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  • NEWS FEATURE
  • 09 July 2024
  • Correction 12 July 2024

How PhD students and other academics are fighting the mental-health crisis in science

  • Shannon Hall

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Illustration: Piotr Kowalczyk

You have full access to this article via your institution.

On the first day of her class, Annika Martin asks the assembled researchers at the University of Zurich in Switzerland to roll out their yoga mats and stand with their feet spread wide apart. They place their hands on their hips before swinging their torsos down towards the mat and back up again. The pose, called ‘wild goose drinking water’ is from Lu Jong, a foundational practice in Tantrayana Buddhism.

Martin, a health psychologist, can sense that some students are sceptical. They are academics at heart, many of whom have never tried yoga, and registered for Martin’s course to learn how to deal with the stress associated with academic research. Over the course of a semester, she teaches her students about stress and its impact on the body before giving them the tools to help cope with it — from yoga, meditation and progressive muscle relaxation to journalling.

It is one of many initiatives designed to combat the mental-health crisis that is gripping science and academia more broadly. The problems are particularly acute for students and early-career researchers, who are often paid meagre wages, have to uproot their lives every few years and have few long-term job prospects. But senior researchers face immense pressure as well. Many academics also experience harassment, discrimination , bullying and even sexual assault . The end result is that students and academics are much more likely to experience depression and anxiety than is the general population.

But some universities and institutions are starting to fight back in creative ways.

The beginning of a movement

The University of Zurich now offers academics several popular courses on mental health. Beyond Martin’s class, called ‘Mindfulness and Meditation’, one helps students learn how to build resilience and another provides senior researchers with the tools they need to supervise PhD candidates.

The courses are in high demand. “We have way more registrations than we have actual course spots,” says Eric Alms, a programme manager who is responsible for many of the mental-health courses at the University of Zurich. “I’m happy that my courses are so successful. On the other hand, it’s a sign of troubling times when these are the most popular courses.”

Several studies over the past few years have collectively surveyed tens of thousands of researchers and have documented the scope and consequences of science’s mental-health crisis.

In 2020, the biomedical research funder Wellcome in London, surveyed more than 4,000 researchers (mostly in the United Kingdom) and found that 70% felt stressed on the average work day . Specifically, survey respondents said that they felt intense pressure to publish — so much so that they work 50–60 hours per week, or more. And they do so for little pay, without a sense of a secure future. Only 41% of mid-career and 31% of early-career researchers said that they were satisfied with their career prospects in research.

Students painting.

The International Max Planck Research School for Intelligent Systems run bootcamps involving activities such as painting. Credit: Alejandro Posada

A survey designed by Cactus Communications , a science-communication and technology company headquartered in Mumbai, India, analysed the opinions of 13,000 researchers in more than 160 countries in 2020 and found that 37% of scientists experienced discrimination, harassment or bullying in their work environment. This was especially true for researchers from under-represented groups and was the case for 42% of female researchers, 45% of homosexual researchers and 60% of multiracial researchers.

Yet some experts are hopeful that there is change afoot. As well as the University of Zurich, several other institutions have started to offer courses on mental health. Imperial College London, for example, conducts more than two dozen courses, workshops and short webinars on topics as diverse as menstrual health and seasonal depression. Most of these have been running for at least five years, but several were developed in response to the COVID-19 pandemic. “At that time, the true dimension of the mental-health crisis in science was unveiled and potentially exacerbated by the lockdowns,” says Ines Perpetuo, a research-development consultant for postdocs and fellows at Imperial College London.

Desiree Dickerson, a clinical psychologist with a PhD in neuroscience who leads workshops at the University of Zurich, Imperial College London and other institutes around the world, says she has a heavier workload than ever before. “Before COVID, this kind of stuff wasn’t really in the spotlight,” she says. “Now it feels like it is gaining a solid foothold — that we are moving in the right direction.”

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A mental-health crisis is gripping science — toxic research culture is to blame

Some of this change has been initiated by graduate students and postdocs. When Yaniv Yacoby was a graduate student in computer science at Harvard University in Cambridge, Massachusetts, for example, he designed a course to teach the “hidden curriculum of the PhD”. The goal was to help students to learn how to succeed in science (often by breaking down preconceived ideas), while creating an inclusive and supportive community. An adapted form of that course is now offered by both Cornell University in Ithaca, New York, and the University of Washington in Seattle. And Yacoby has worked with other universities to develop single-session workshops to jump-start mental-health advocacy and normalize conversations about it in academia.

Similarly, Jessica Noviello, a planetary scientist at NASA’s Goddard Space Flight Center in Greenbelt, Maryland, built a workshop series designed to target a key stressor for academics’ mental health: job insecurity, or specifically, the ability to find a job that aligns with career plans and life goals. She argues that most advisers lack experience outside academia, “making it hard for them to advise students about other career options”, and most institutes don’t have the resources to bring in outside speakers. Yet it is a key issue. The 2020 Wellcome survey found that nearly half of the respondents who had left research reported difficulty in finding a job.

So Noviello established the Professional Advancement Workshop Series (PAWS) in August 2021. The programme has run workshops and panel discussions about careers at national laboratories and in science journalism and media communications, science policy, data science, NASA management and more. And it has hosted two sessions on mental-health topics. “PAWS isn’t a programme that specifically set out to improve mental health in the sciences, but by building a community and having conversations with each other, the experts, and ourselves, I think we are giving ourselves tools to make choices that benefit us, and that is where mental health begins,” Noviello says.

Beyond the classroom

Although these courses and workshops mark a welcome change, say researchers, many wonder whether they are enough.

Melanie Anne-Atkins, a clinical psychologist and the associate director of student experience at the University of Guelph in Canada, who gives talks on mental health at various universities, says that she rarely sees universities follow through after her workshops. “People are moved to tears,” she says. “But priorities happen afterward. And even though they made a plan, it never rises to that. Because dollars will always come first.”

David Trang, a planetary geologist based in Honolulu, Hawaii, at the Space Science Institute, is currently working towards a licence in mental-health counselling to promote a healthier work environment in the sciences. He agrees with Anne-Atkins — arguing that even individual researchers have little incentive to make broad changes. “Caring about mental health, caring about diversity, equity and inclusion is not going to help scientists with their progress in science,” he says. Although they might worry about these matters tremendously, Trang argues, mental-health efforts won’t help scientists to win a grant or receive tenure. “At the end of the day, they have to care about their own survival in science.”

Still, others argue that these workshops are a natural and crucial first step — that people need to de-stigmatize these topics before moving forward. “It is quite a big challenge,” Perpetuo says. “But you have to understand what’s under your control. You can control your well-being, your reactions to things and you can influence what’s around you.”

Two PhD students doing a relay race, once carrying the other in a wheel barrel on the grass.

PhD students compete in a team-building relay race at a bootcamp run by the International Max Planck Research School for Intelligent Systems. Credit: Alejandro Posada

That is especially pertinent to the typical scientist who tends to see their work as a calling and not just a job, argues Nina Effenberger, who is studying computer science at the University of Tübingen in Germany. The Wellcome survey found that scientists are often driven by their own passion — making failure deeply personal. But a solid mental-health toolkit (one that includes the skills taught in many of the new workshops) will help them to separate their work from their identity and understand that a grant denial or a paper rejection is not the end of their career. Nor should it have any bearing on their self-worth, Effenberger argues. It is simply a part of a career in science.

Moreover, Dickerson argues that although systemic change is necessary, individuals will drive much of that change. “My sense is that if I can empower the individual, then that individual can also push back,” she says.

Many researchers are starting to do just that through efforts aimed at improving working conditions for early-career researchers, an area of widespread concern. The Cactus survey found that 38% of researchers were dissatisfied with their financial situation. And another survey of 3,500 graduate students by the US National Science Foundation in 2020 (see go.nature.com/3xbokbk) found that more than one-quarter of the respondents experienced food insecurity, housing insecurity or both.

In the United States, efforts to organize unions have won salary increases and other benefits, such as childcare assistance, at the University of California in 2022, Columbia University in New York City in 2023 and the University of Washington in 2023. These wins are part of a surge in union formation. Last year alone, 26 unions representing nearly 50,000 graduate students, postdocs and researchers, formed in the United States.

There has also been collective action in other countries. In 2022, for example, graduate students ran a survey on their finances, and ultimately won an increase in pay at the International Max Planck Research School for Intelligent Systems (IMPRS-IS), an interdisciplinary doctoral programme within the Max Planck Society in Munich, Germany.

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Why the mental cost of a STEM career can be too high for women and people of colour

Union drives are only part of the changes that are happening beyond the classroom. In the past few years, Imperial College London has revamped its common rooms, lecture halls and other spaces to create more places in which students can congregate. “If they have a space where they can go and chat, it is more conducive to research conversations and even just personal connection, which is one of the key aspects of fostering mental health,” Perpetuo says. Imperial also introduced both one-day and three-day voluntary retreats for postdocs and fellows to build personal relationships.

The IMPRS-IS similarly runs ‘bootcamps’ or retreats for many of its doctoral students and faculty members. Dickerson spoke at the one last year. The programme also mandates annual check-ins at which students can discuss group dynamics and raise any issues with staff. It has initiated thesis advisory committees so that no single academic supervisor has too much power over a student. And it plans to survey its students’ mental health twice a year for the next three years to probe the mental health of the institute. The institute has even set various mental-health goals, such as high job satisfaction among PhD students regardless of gender.

Dickerson applauds this change. “One of the biggest problems that I see is a fear of measuring the problem,” she says. “Many don’t want to ask the questions and I think those that do should be championed because I think without measuring it, we can’t show that we are actually changing anything.”

She hopes that other universities will follow suit and provide researchers with the resources that they need to improve conditions. Last year, for example, Trang surveyed the planetary-science community and found that imposter syndrome and feeling unappreciated were large issues — giving him a focus for many future workshops. “We’re moving slowly to make changes,” he says. “But I’m glad we are finally turning the corner from ‘if there is a problem’ to ‘let’s start solving the problem.’”

Nature 631 , 496-498 (2024)

doi: https://doi.org/10.1038/d41586-024-02225-8

Updates & Corrections

Correction 12 July 2024 : An earlier version of this story incorrectly said that Nina Effenberger was involved in a survey on graduate-student finances that won an increase in pay.

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55 research questions about mental health

Last updated

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Brittany Ferri, PhD, OTR/L

Short on time? Get an AI generated summary of this article instead

Research in the mental health space helps fill knowledge gaps and create a fuller picture for patients, healthcare professionals, and policymakers. Over time, these efforts result in better quality care and more accessible treatment options for those who need them.

Use this list of mental health research questions to kickstart your next project or assignment and give yourself the best chance of producing successful and fulfilling research.

  • Why does mental health research matter?

Mental health research is an essential area of study. It includes any research that focuses on topics related to people’s mental and emotional well-being.

As a complex health topic that, despite the prevalence of mental health conditions, still has an unending number of unanswered questions, the need for thorough research into causes, triggers, and treatment options is clear.

Research into this heavily stigmatized and often misunderstood topic is needed to find better ways to support people struggling with mental health conditions. Understanding what causes them is another crucial area of study, as it enables individuals, companies, and policymakers to make well-informed choices that can help prevent illnesses like anxiety and depression.

  • How to choose a strong mental health research topic

As one of the most important parts of beginning a new research project, picking a topic that is intriguing, unique, and in demand is a great way to get the best results from your efforts.

Mental health is a blanket term with many niches and specific areas to explore. But, no matter which direction you choose, follow the tips below to ensure you pick the right topic.

Prioritize your interests and skills

While a big part of research is exploring a new and exciting topic, this exploration is best done within a topic or niche in which you are interested and experienced.

Research is tough, even at the best of times. To combat fatigue and increase your chances of pushing through to the finish line, we recommend choosing a topic that aligns with your personal interests, training, or skill set.

Consider emerging trends

Topical and current research questions are hot commodities because they offer solutions and insights into culturally and socially relevant problems.

Depending on the scope and level of freedom you have with your upcoming research project, choosing a topic that’s trending in your area of study is one way to get support and funding (if you need it).

Not every study can be based on a cutting-edge topic, but this can be a great way to explore a new space and create baseline research data for future studies.

Assess your resources and timeline

Before choosing a super ambitious and exciting research topic, consider your project restrictions.

You’ll need to think about things like your research timeline, access to resources and funding, and expected project scope when deciding how broad your research topic will be. In most cases, it’s better to start small and focus on a specific area of study.

Broad research projects are expensive and labor and resource-intensive. They can take years or even decades to complete. Before biting off more than you can chew, consider your scope and find a research question that fits within it.

Read up on the latest research

Finally, once you have narrowed in on a specific topic, you need to read up on the latest studies and published research. A thorough research assessment is a great way to gain some background context on your chosen topic and stops you from repeating a study design. Using the existing work as your guide, you can explore more specific and niche questions to provide highly beneficial answers and insights.

  • Trending research questions for post-secondary students

As a post-secondary student, finding interesting research questions that fit within the scope of your classes or resources can be challenging. But, with a little bit of effort and pre-planning, you can find unique mental health research topics that will meet your class or project requirements.

Examples of research topics for post-secondary students include the following:

How does school-related stress impact a person’s mental health?

To what extent does burnout impact mental health in medical students?

How does chronic school stress impact a student’s physical health?

How does exam season affect the severity of mental health symptoms?

Is mental health counseling effective for students in an acute mental crisis?

  • Research questions about anxiety and depression

Anxiety and depression are two of the most commonly spoken about mental health conditions. You might assume that research about these conditions has already been exhausted or that it’s no longer in demand. That’s not the case at all.

According to a 2022 survey by Centers for Disease Control and Prevention (CDC), 12.5% of American adults struggle with regular feelings of worry, nervousness, and anxiety, and 5% struggle with regular feelings of depression. These percentages amount to millions of lives affected, meaning new research into these conditions is essential.

If either of these topics interests you, here are a few trending research questions you could consider:

Does gender play a role in the early diagnosis of anxiety?

How does untreated anxiety impact quality of life?

What are the most common symptoms of anxiety in working professionals aged 20–29?

To what extent do treatment delays impact quality of life in patients with undiagnosed anxiety?

To what extent does stigma affect the quality of care received by people with anxiety?

Here are some examples of research questions about depression:

Does diet play a role in the severity of depression symptoms?

Can people have a genetic predisposition to developing depression?

How common is depression in work-from-home employees?

Does mood journaling help manage depression symptoms?

What role does exercise play in the management of depression symptoms?

  • Research questions about personality disorders

Personality disorders are complex mental health conditions tied to a person’s behaviors, sense of self, and how they interact with the world around them. Without a diagnosis and treatment, people with personality disorders are more likely to develop negative coping strategies during periods of stress and adversity, which can impact their quality of life and relationships.

There’s no shortage of specific research questions in this category. Here are some examples of research questions about personality disorders that you could explore:

What environments are more likely to trigger the development of a personality disorder?

What barriers impact access to care for people with personality disorders?

To what extent does undiagnosed borderline personality disorder impact a person’s ability to build relationships?

How does group therapy impact symptom severity in people with schizotypal personality disorder?

What is the treatment compliance rate of people with paranoid personality disorder?

  • Research questions about substance use disorders

“Substance use disorders” is a blanket term for treatable behaviors and patterns within a person’s brain that lead them to become dependent on illicit drugs, alcohol, or prescription medications. It’s one of the most stigmatized mental health categories.

The severity of a person’s symptoms and how they impact their ability to participate in their regular daily life can vary significantly from person to person. But, even in less severe cases, people with a substance use disorder display some level of loss of control due to their need to use the substance they are dependent on.

This is an ever-evolving topic where research is in hot demand. Here are some example research questions:

To what extent do meditation practices help with craving management?

How effective are detox centers in treating acute substance use disorder?

Are there genetic factors that increase a person’s chances of developing a substance use disorder?

How prevalent are substance use disorders in immigrant populations?

To what extent do prescription medications play a role in developing substance use disorders?

  • Research questions about mental health treatments

Treatments for mental health, pharmaceutical therapies in particular, are a common topic for research and exploration in this space.

Besides the clinical trials required for a drug to receive FDA approval, studies into the efficacy, risks, and patient experiences are essential to better understand mental health therapies.

These types of studies can easily become large in scope, but it’s possible to conduct small cohort research on mental health therapies that can provide helpful insights into the actual experiences of the people receiving these treatments.

Here are some questions you might consider:

What are the long-term effects of electroconvulsive therapy (ECT) for patients with severe depression?

How common is insomnia as a side effect of oral mental health medications?

What are the most common causes of non-compliance for mental health treatments?

How long does it take for patients to report noticeable changes in symptom severity after starting injectable mental health medications?

What issues are most common when weaning a patient off of an anxiety medication?

  • Controversial mental health research questions

If you’re interested in exploring more cutting-edge research topics, you might consider one that’s “controversial.”

Depending on your own personal values, you might not think many of these topics are controversial. In the context of the research environment, this depends on the perspectives of your project lead and the desires of your sponsors. These topics may not align with the preferred subject matter.

That being said, that doesn’t make them any less worth exploring. In many cases, it makes them more worthwhile, as they encourage people to ask questions and think critically.

Here are just a few examples of “controversial” mental health research questions:

To what extent do financial crises impact mental health in young adults?

How have climate concerns impacted anxiety levels in young adults?

To what extent do psychotropic drugs help patients struggling with anxiety and depression?

To what extent does political reform impact the mental health of LGBTQ+ people?

What mental health supports should be available for the families of people who opt for medically assisted dying?

  • Research questions about socioeconomic factors & mental health

Socioeconomic factors—like where a person grew up, their annual income, the communities they are exposed to, and the amount, type, and quality of mental health resources they have access to—significantly impact overall health.

This is a complex and multifaceted issue. Choosing a research question that addresses these topics can help researchers, experts, and policymakers provide more equitable and accessible care over time.

Examples of questions that tackle socioeconomic factors and mental health include the following:

How does sliding scale pricing for therapy increase retention rates?

What is the average cost to access acute mental health crisis care in [a specific region]?

To what extent does a person’s environment impact their risk of developing a mental health condition?

How does mental health stigma impact early detection of mental health conditions?

To what extent does discrimination affect the mental health of LGBTQ+ people?

  • Research questions about the benefits of therapy

Therapy, whether that’s in groups or one-to-one sessions, is one of the most commonly utilized resources for managing mental health conditions. It can help support long-term healing and the development of coping mechanisms.

Yet, despite its popularity, more research is needed to properly understand its benefits and limitations.

Here are some therapy-based questions you could consider to inspire your own research:

In what instances does group therapy benefit people more than solo sessions?

How effective is cognitive behavioral therapy for patients with severe anxiety?

After how many therapy sessions do people report feeling a better sense of self?

Does including meditation reminders during therapy improve patient outcomes?

To what extent has virtual therapy improved access to mental health resources in rural areas?

  • Research questions about mental health trends in teens

Adolescents are a particularly interesting group for mental health research due to the prevalence of early-onset mental health symptoms in this age group.

As a time of self-discovery and change, puberty brings plenty of stress, anxiety, and hardships, all of which can contribute to worsening mental health symptoms.

If you’re looking to learn more about how to support this age group with mental health, here are some examples of questions you could explore:

Does parenting style impact anxiety rates in teens?

How early should teenagers receive mental health treatment?

To what extent does cyberbullying impact adolescent mental health?

What are the most common harmful coping mechanisms explored by teens?

How have smartphones affected teenagers’ self-worth and sense of self?

  • Research questions about social media and mental health

Social media platforms like TikTok, Instagram, YouTube, Facebook, and X (formerly Twitter) have significantly impacted day-to-day communication. However, despite their numerous benefits and uses, they have also become a significant source of stress, anxiety, and self-worth issues for those who use them.

These platforms have been around for a while now, but research on their impact is still in its infancy. Are you interested in building knowledge about this ever-changing topic? Here are some examples of social media research questions you could consider:

To what extent does TikTok’s mental health content impact people’s perception of their health?

How much non-professional mental health content is created on social media platforms?

How has social media content increased the likelihood of a teen self-identifying themselves with ADHD or autism?

To what extent do social media photoshopped images impact body image and self-worth?

Has social media access increased feelings of anxiety and dread in young adults?

  • Mental health research is incredibly important

As you have seen, there are so many unique mental health research questions worth exploring. Which options are piquing your interest?

Whether you are a university student considering your next paper topic or a professional looking to explore a new area of study, mental health is an exciting and ever-changing area of research to get involved with.

Your research will be valuable, no matter how big or small. As a niche area of healthcare still shrouded in stigma, any insights you gain into new ways to support, treat, or identify mental health triggers and trends are a net positive for millions of people worldwide.

Should you be using a customer insights hub?

Do you want to discover previous research faster?

Do you share your research findings with others?

Do you analyze research data?

Start for free today, add your research, and get to key insights faster

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Why the reliance on data? Findings and statistics from research studies can impact us emotionally, add credibility to an article, and ground us in the real world. However, the importance of research findings reaches far beyond providing knowledge to the general population. Research and evaluation studies — those studies that assess a program’s impact — are integral to promoting mental health and reducing the burden of mental illness in different populations.

Mental health research identifies biopsychosocial factors — how biological, psychological and social functioning are interacting — detecting trends and social determinants in population health. That data greatly informs the current state of mental health in the U.S. and around the world. Findings from such studies also influence fields such as public health, health care and education. For example, mental health research and evaluation can impact public health policies by assisting public health professionals in strategizing policies to improve population mental health.

Research helps us understand how to best promote mental health in different populations. From its definition to how it discussed, mental health is seen differently in every community. Thus, mental health research and evaluation not only reveals mental health trends but also informs us about how to best promote mental health in different racial and ethnic populations. What does mental health look like in this community? Is there stigma associated with mental health challenges? How do individuals in the community view those with mental illness? These are the types of questions mental health research can answer.

Data aids us in understanding whether the mental health services and resources that are available meet mental health needs. Many times the communities where needs are the greatest are the ones where there are limited services and resources available. Mental health research and evaluation informs public health professionals and other relevant stakeholders of the gaps that currently exist so they can prioritize policies and strategies for communities where gaps are the greatest.

Research establishes evidence for the effectiveness of public health policies and programs. Mental health research and evaluation help develop evidence for the effectiveness of healthcare policies and strategies as well as mental health promotion programs. This evidence is crucial for showcasing the value and return on investment for programs and policies, which can justify local, state and federal expenditures. For example, mental health research studies evaluating the impact of Mental Health First Aid (MHFA) have revealed that individuals taking the course show increases in knowledge about mental health, greater confidence to assist others in distress, and improvements in their own mental wellbeing. They have been fundamental in assisting organizations and instructors in securing grant funding to bring MHFA to their communities.

The findings from mental health research and evaluation studies provide crucial information about the specific needs within communities and the impacts of public education programs like MHFA. These studies provide guidance on how best to improve mental health in different contexts and ensure financial investments go towards programs proven to improve population mental health and reduce the burden of mental illness in the U.S.

In 2021, in a reaffirmation of its dedication and commitment to mental health and substance use research and community impact, Mental Health First Aid USA introduced MHFA Research Advisors. The group advises and assists Mental Health First Aid USA on ongoing research and future opportunities related to individual MHFA programs, including Youth MHFA, teen MHFA and MHFA at Work.

Through this advisory group and evaluation efforts at large, Mental Health First Aid USA will #BeTheDifference for mental health research and evaluation across communities in the US.

Learn more about MHFA Research Advisors and how you can share your research with us.

Get the latest MHFA blogs, news and updates delivered directly to your inbox so you never miss a post.

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Guidance on Conducting Research Involving Mental Health Topics

In human subjects research, many studies utilize questionnaires and assessments that address mental health, behavior or quality of life. These may include questions and assessments of the subject’s intent to harm him/herself or others. As part of its responsibility to protect research subjects, COUHES evaluates the risks and benefits of asking study participants about these topics.

This guidance document is intended to help researchers determine the appropriateness of including mental health topics in their research and considerations in developing acceptable plans for mitigating any potential risk.

Identifying Risk of Harm

Intentional identification.

Studies may be designed to gauge intent to harm self or others. This may be done through assessments such as behavioral evaluations, interviews, surveys or other measures for depression and suicidality.

When using such clinical diagnostic measures, researchers should consider if the study setting and population are appropriate with regards to the safety, risk-benefit ratio, and knowledge to be gained. If these measures identify study participants as clinically at-risk, or the study targets populations at high risk for injury to self or others, the COUHES application must include a a safety plan that describes what actions will be taken to ensure the safety of at-risk participants.

Unintentional Identification

For studies that include quality-of-life assessments or questionnaires that ask about sadness, anxiousness, or stress, the identification of a participant at-risk for harm to self or others may be unintentional. This is because these assessments are not typically designed for diagnostic purposes.

COUHES evaluates if a safety plan is needed for such studies on a case-by-case basis. A plan may be required if responses reveal acute risk (e.g. imminent danger to self or severe low mood) or if the study population is at elevated risk (e.g. receiving mental health treatment for depression, mood, or anxiety disorders).

In-Person vs. Remote Identification

When conducting research related to mental health, researchers should consider the physical environment where the study procedures will take place, and how participants will be adequately protected in that environment. Safety and ethical considerations can differ depending on whether the participants complete the intervention remotely or in-person, and whether the researchers know the identity of the participant or study participation is anonymous.

Creating a Participant Safety Plan

For studies that may identify a participant is at immediate or emerging risk for harming self or others, researchers must develop a safety plan.

The key to a safety plan is an assessment of how imminent is the risk. How this assessment is made can vary depending on: whether study procedures are carried out remotely or in-person; in a clinical, laboratory, or other setting; or whether the information is collected anonymously or not tied to an individual.

The COUHES application must explain:

  • How the risk will be assessed;
  • When investigators will review a subject’s response to questionnaires and assessments, and the frequency at which this review will occur; and
  • By whom the level and immediacy of risk will be assessed.

If participants’ responses will not be individually assessed, the COUHES application should explain why the investigators believe an individually identifiable assessment will not be included.

Any researchers administering the clinical measures and assessments, or reviewing a subject’s responses, should be appropriately qualified to assess the measures and assessments, and be familiar with the safety plan. In particular, individuals that are assessing participants’ risk of harm to self or others must have appropriate training in the assessment and implementation of the safety plan.

Intervention

Safety plans described in a COUHES application may include the follow, as appropriate:

  • If participants will be provided mental health or other resources, a copy of the resource referral document, and an explanation of how/when the resources will be made accessible to participants. 
  • For assessments that determine imminent risk, procedures on transferring the participant to appropriate crisis intervention or de-escalation resources.
  • For assessments that determine less than imminent risk, referral or intervention procedures and how this information is communicated to participants.
  • For research that gathers anonymous information or where responses are not tied to an individual the plan should provide for a resource referral document to be given to participants that includes mental health resources, crisis intervention services, or hotline information depending on the type of risk.
  • Qualifications of researchers and/or clinicians involved in participant interactions, assessments, and safety interventions.
  • Confirmation that research staff directly interacting with participants will be adequately trained on the safety plan.
  • If participants and parents/legal guardians, as applicable, will be notified of findings.
  • If information is reportable under state or federal law, plans for notifying the relevant authorities and/or agencies under mandated reporting requirements.

Consent Process

As part of the consent process, consent forms should:

  • Clearly explain to potential participants the sensitive nature of any interviews or questionnaires;
  • Describe what will happen if participants acknowledge/disclose harm to self or others;
  • Have information on the risks and benefits of participating in this type of research. For example, for research with populations at elevated risk, include that the involvement in the research does not provide participants with “protection” against future harmful behavior, and how potential risk is mitigated; and
  • Include any limitations on data confidentiality in the Privacy and Confidentiality section. If information collected during research must be disclosed under mandated reporting requirements, this must be included. Language regarding mandated reporting may be reviewed by MIT Office of General Counsel.

Appendix: Suggested Consent Language

For research that gathers anonymous information and researchers plan only to provide resources, the consent process should not lead participants to think that the researchers will provide immediate assistance. Suggested language to add in the risk section is as follows:

There are no anticipated risks from your participation in this study. However, some people become anxious or upset when answering questions about (behaviors, well-being, mood, views). Your responses will not be individually identified, so we cannot provide you with personal feedback or intervention based on any of your answers. If you are worried about your mood, please refer to the attached resource referral information sheet.

If responses will be individually assessed and can be linked back to participants, the consent form should explain what options the participant will have if they become upset or uncomfortable during study activities. For example:

In the event that you tell the research team you are thinking about harming yourself or others, the research team will provide you resources and may ask you more questions about these thoughts. Based on your responses, the research team may provide you will additional resources or assistance to identify appropriate follow-up. This may include working with you to contact your doctor, contacting a trusted family member or therapist to discuss your thoughts, or working with you on a plan that may include getting you to a hospital for safety.

When using clinical diagnostic or symptom severity measures, participants scores above a pre-defined threshold of the measure should be reported back to the participant with an offer for referrals and/or counseling resources. The threshold for intervention needs to be defined in the COUHES application along with when and how the study findings will be shared with participants. Researchers should be prepared to offer appropriate counseling resources, assistance in making appointments, and/or offering a list of referrals. An example email message is below:

I am part of the team for a research study you recently completed. Based in your responses to some of the questions we asked, you seem to be experiencing (sadness, stress, blue moods, etc.). We provided you some information about mental health resources, but I wanted to follow-up and offer any other information you might want to get help.

To assist investigators with identifying counseling resources, COUHES provides the following:

Conducting Research on Mental Health Topics - Participant Counseling Resources [PDF]

The links below provide additional guidance for engaging participants on the topic of mental health.

  • National Institute of Mental Health (NIMH): Conducting Research with Participants at Elevated
  • Risk for Suicide: Considerations for Researchers
  • NIMH Clinical Research Toolbox
  • NIMH Guidance on Risk-Based Monitoring
  • FDA Guidance for Industry, Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials
  • FDA Guidance for Industry, Major Depressive Disorder: Developing Drugs for Treatment
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  • Additional Standard Language for Informed Consent
  • Basic Elements of Informed Consent
  • Waiver or Alteration of Informed Consent or Waiver of Documentation of Informed Consent
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Can marijuana ease mental health conditions?

New studies seek to deliver a better understanding of how cannabis may help reduce pain, PTSD and anxiety

By Sara Zaske

December 2018, Vol 49, No. 11

Print version: page 22

Marijuana plant

  • Substance Use, Abuse, and Addiction

So far, medical marijuana has been legalized in 31 states and nine have legalized its recreational use. The Marijuana Policy Project estimates that more than 2.8 million people in the United States are using marijuana, or cannabis, as medicine. Recreational use is even higher, with more than 22.2 million users, according to a 2015 national survey .

As one researcher, neuroscientist Staci Gruber, PhD, an associate professor of psychiatry at Harvard Medical School, puts it, "Marijuana is like rock ’n’ roll; it’s here to stay."

While the popularity of marijuana has surged, research on its therapeutic properties has lagged well behind, especially when it comes to mental health and other outcomes. That disconnect has compelled researchers like Gruber to study cannabis despite the many obstacles posed by its unsettled legal status.

"Given that so many people are using marijuana, it’s my job to help patients and consumers figure out the very best ways in which they might be able to use these products safely and effectively," Gruber says.

In 2017, the National Academies of Sciences, Engineering, and Medicine produced an extensive review on the health effects of cannabis and its 113 chemical constituents, called cannabinoids. While looking at a wide range of studies published since 1999, the review found that only three therapeutic uses were backed by substantial or conclusive evidence: treating chronic pain, reducing nausea induced by chemotherapy treatment and decreasing the spasticity associated with multiple sclerosis.

"Despite what we hear in the media and despite popular belief, there actually is very little known about the therapeutic effects in the human population," says behavioral pharmacologist Ziva Cooper, PhD, one of the review’s authors and an associate professor of clinical neurobiology at Columbia University Medical Center.

The review noted that chronic pain is the most common reason people cite for seeking medical marijuana—94 percent of Colorado medical marijuana ID cardholders said they had "severe pain." At the same time, the review identified 27 randomized trials involving a total of nearly 2,500 participants with chronic pain, mostly related to neuropathy, that showed cannabis and cannabinoids provided significant pain relief over that of a placebo.

Given this evidence, Cooper decided to take a closer look at whether cannabinoids might help reduce, or even replace, the use of opioids for pain relief. She also noted that animal studies have indicated that cannabinoids can help decrease the dose of opioids needed to reduce pain. In states that have legalized medical marijuana, prescription opioid use and rates of opioid-related deaths have decreased, according to studies published in JAMA Internal Medicine ( Vol. 174, No. 10, 2014 , and Vol. 178, No. 5, 2018 ).

To test the efficacy of cannabis for pain relief, Cooper and colleagues conducted a double-blind placebo-controlled study looking at cannabis use in conjunction with opioids ( Neuropsychopharmacology , Vol. 43, 2018). The study measured healthy participants’ pain thresholds and tolerance levels by immersing their hands in cold water. The researchers found that when combining cannabis with a very small dose of an opioid—one that was not analgesic on its own—patients had robust pain relief.

"It was very encouraging," Cooper says. "It shows cannabinoids might actually be an adjunct for opioids for pain relief and could potentially decrease the adverse effects of the opioids."

Her next study, which will take a similar approach, will look at the potential impact of cannabis with different amounts of cannabinoids in conjunction with opioids. Specifically, Cooper wants to know if tetrahydrocannabinol, or THC, the primary psychoactive component of cannabis, is necessary to achieve pain relief. She is planning to test whether another non­psychoactive cannabinoid known as cannabidiol, or CBD, could also achieve the same effect.

The research gap

Marcel Bonn-Miller, PhD, an adjunct assistant professor of psychology in psychiatry at the University of Pennsylvania, is also examining the effects of these same two cannabinoids, but to address a different kind of pain: the psychological suffering caused by post-traumatic stress disorder (PTSD).

When Bonn-Miller first started conducting research on the disorder 15 years ago at the University of Vermont, he heard many patients report using marijuana to ease their symptoms, but he could find only two published studies on cannabis and PTSD. "It seemed like such a huge gap that needed to be addressed," he says.

Currently, PTSD patients are often treated with behavioral therapies, such as prolonged exposure and cognitive processing therapy. While these treatments work well for some people, they don’t work for everyone. "A lot of people are looking for medication," Bonn-Miller says. "And there really aren’t any medications that work well."

Bonn­-Miller is leading two of the largest and longest studies ever done on cannabinoids and PTSD. The first study is a double-blind controlled trial that compares different cannabinoids. In the trial, about 76 participants, mostly veterans with PTSD, are being put in one of four groups, receiving either cannabis with high THC, cannabis with high CBD, a strain with equal levels, or a placebo.

The cannabis used in this study is all grown at the University of Mississippi, the only federally approved source for cannabis administered in research labs. (It’s worth noting, however, that the types of cannabis people actually use are often much stronger and come in more varieties than that grown at the university.)

Bonn-Miller’s second project attempts to address this problem. It’s an observational study in which half of the 150 study participants use cannabis purchased at dispensaries in Denver. The other half are nonusers. Bonn-Miller’s team will analyze the types of cannabis used and track participants’ PTSD symptoms every three months for a year.

In related work, Mallory Loflin, PhD, a research scientist with the Center of Excellence for Stress and Mental Health at the VA San Diego Healthcare System, is launching a double-blind placebo-controlled study to test the efficacy of CBD in conjunction with prolonged exposure therapy. While it’s considered to be one of the most effective PTSD treatments, prolonged exposure therapy does not always result in full remission of symptoms and can be emotionally challenging for some patients. Loflin will test the hypothesis that using CBD can increase the efficiency and efficacy of prolonged exposure therapy in PTSD patients as well as improve its tolerability.

The study, which will involve 136 military veterans with PTSD, is a landmark one not only because of its subject matter but also because of its funder: It is the first research project involving cannabinoids to be funded by the Department of Veterans Affairs.

Beyond the high

Gruber also heads a privately funded project, Marijuana Investigations for Neuroscientific Discovery (MIND). Started in 2014, MIND’s mission is to study the effects of cannabis and cannabinoids on patients’ cognitive performance, conventional medication use, sleep, quality of life, measures of brain structure and function, mental health and other variables.

Gruber, who is also the director of the Cognitive and Clinical Neuroimaging Core at McLean Hospital’s Brain Imaging Center, has worked with recreational marijuana users for over 20 years, but the MIND program focuses on medical marijuana users—and the two populations are very different.

Recreational consumers are happy to say they use marijuana because they want to change their mental states, but many of Gruber’s medical marijuana patients tell her they don’t want to get high: They just want to feel better.

MIND has conducted a number of studies on patients using cannabis for medical purposes, looking at the impact on their cognitive performance over time, starting before use and following them at three- and six-month intervals for up to two years.

These studies have found that the patients, who used cannabis to treat a range of medical problems including anxiety, had largely improved cognitive performance, reduced clinical symptoms and anxiety-related symptoms as well as a reduced use of conventional medications, including opioids, benzodiazepines, and other mood stabilizers and antidepressants.

Those results inspired and informed Gruber’s open-label to double-blind clinical trial on patients with anxiety using a whole-plant, high-CBD tincture. While some studies have found a negative connection between smoked whole-plant marijuana and social anxiety specifically, there has yet to be a double- blind placebo-controlled trial looking at CBD and anxiety. Gruber is hoping this first-ever clinical trial will provide much-needed information on CBD. The trial is in the beginning stages of enrolling participants.

Studying medical marijuana remains challenging, but like many researchers in this field, Gruber is optimistic.

"This is a difficult landscape to navigate," she says, "and while the potential of cannabis and cannabinoid-based therapies for a multitude of indications, symptoms and conditions is extraordinary, we are in desperate need of empirically sound data."

Further reading

The Role of Cannabis Legalization in the Opioid Crisis Hill, K.P., et al., JAMA Internal Medicine , 2018

Impact of Co-administration of Oxycodone and Smoked Cannabis on Analgesia and Abuse Liability Cooper, Z.D., et al., Neuropsycho­pharmacology , 2018

Marijuana Use in the United States National Institute on Drug Abuse, www.drugabuse.gov/publications/research-reports/marijuana/what-scope-marijuana-use-in-united-states

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A new strategy to cope with emotional stress

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A woman in uniform sitting in a locker room with helmet in lap, head down, and eyes closed, being consoled by a colleague.

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Some people, especially those in public service, perform admirable feats: Think of health-care workers fighting to keep patients alive or first responders arriving at the scene of a car crash. But the emotional weight can become a mental burden. Research has shown that emergency personnel are at elevated risk for mental health challenges like post-traumatic stress disorder. How can people undergo such stressful experiences and also maintain their well-being?

A new study from the McGovern Institute for Brain Research at MIT revealed that a cognitive strategy focused on social good may be effective in helping people cope with distressing events. The research team found that the approach was comparable to another well-established emotion regulation strategy, unlocking a new tool for dealing with highly adverse situations.

“How you think can improve how you feel,” says  John Gabrieli , the Grover Hermann Professor of Health Sciences and Technology and a professor of brain and cognitive sciences at MIT, who is a senior author of the paper. “This research suggests that the social good approach might be particularly useful in improving well-being for those constantly exposed to emotionally taxing events.”

The study, published today in PLOS ONE , is the first to examine the efficacy of this cognitive strategy. Nancy Tsai, a postdoc in  Gabrieli’s lab at the McGovern Institute, is the lead author of the paper.

Emotion regulation tools

Emotion regulation is the ability to mentally reframe how we experience emotions — a skill critical to maintaining good mental health. Doing so can make one feel better when dealing with adverse events, and emotion regulation has been shown to boost emotional, social, cognitive, and physiological outcomes across the lifespan.

One emotion regulation strategy is “distancing,” where a person copes with a negative event by imagining it as happening far away, a long time ago, or from a third-person perspective. Distancing has been well-documented as a useful cognitive tool, but it may be less effective in certain situations, especially ones that are socially charged — like a firefighter rescuing a family from a burning home. Rather than distancing themselves, a person may instead be forced to engage directly with the situation.

“In these cases, the ‘social good’ approach may be a powerful alternative,” says Tsai. “When a person uses the social good method, they view a negative situation as an opportunity to help others or prevent further harm.” For example, a firefighter experiencing emotional distress might focus on the fact that their work enables them to save lives. The idea had yet to be backed by scientific investigation, so Tsai and her team, alongside Gabrieli, saw an opportunity to rigorously probe this strategy.

A novel study

The MIT researchers recruited a cohort of adults and had them complete a questionnaire to gather information including demographics, personality traits, and current well-being, as well as how they regulated their emotions and dealt with stress. The cohort was randomly split into two groups: a distancing group and a social good group. In the online study, each group was shown a series of images that were either neutral (such as fruit) or contained highly aversive content (such as bodily injury). Participants were fully informed of the kinds of images they might see and could opt out of the study at any time.

Each group was asked to use their assigned cognitive strategy to respond to half of the negative images. For example, while looking at a distressing image, a person in the distancing group could have imagined that it was a screenshot from a movie. Conversely, a subject in the social good group might have responded to the image by envisioning that they were a first responder saving people from harm. For the other half of the negative images, participants were asked to only look at them and pay close attention to their emotions. The researchers asked the participants how they felt after each image was shown.

Social good as a potent strategy

The MIT team found that distancing and social good approaches helped diminish negative emotions. Participants reported feeling better when they used these strategies after viewing adverse content compared to when they did not, and stated that both strategies were easy to implement.

The results also revealed that, overall, distancing yielded a stronger effect. Importantly, however, Tsai and Gabrieli believe that this study offers compelling evidence for social good as a powerful method better-suited to situations when people cannot distance themselves, like rescuing someone from a car crash, “Which is more probable for people in the real world,” notes Tsai. Moreover, the team discovered that people who most successfully used the social good approach were more likely to view stress as enhancing rather than debilitating. Tsai says this link may point to psychological mechanisms that underlie both emotion regulation and how people respond to stress.

Additionally, the results showed that older adults used the cognitive strategies more effectively than younger adults. The team suspects that this is probably because, as prior research has shown, older adults are more adept at regulating their emotions, likely due to having greater life experiences. The authors note that successful emotion regulation also requires cognitive flexibility, or having a malleable mindset to adapt well to different situations.

“This is not to say that people, such as physicians, should reframe their emotions to the point where they fully detach themselves from negative situations,” says Gabrieli. “But our study shows that the social good approach may be a potent strategy to combat the immense emotional demands of certain professions.”

The MIT team says that future studies are needed to further validate this work, and that such research is promising in that it can uncover new cognitive tools to equip individuals to take care of themselves as they bravely assume the challenge of taking care of others.

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Study: AANHPI less likely to seek mental health help

Mental health challenges affect Asian Americans, Native Hawaiians and Pacific Islanders (AANHPI) communities disproportionately, yet they are less likely to seek help, a recent University of California, Los Angeles Center for Health Policy Research study found. The research, which analyzed mental health experiences of these communities in California, found that half of respondents reported daily discrimination, and a fifth of Asian Americans experienced hate crimes.

Ninez A. Ponce

How small lifestyle changes can improve teen mental health over time

Judging by  recent headlines  and  policy ideas , you might think screen time is the only lifestyle behaviour influencing teen wellbeing.

But with young people struggling to deal with mounting  mental health issues , it’s crucial we don’t get tunnel vision and instead remember all the lifestyle levers that can play a role.

The research,  published here , tracked Australian high school students from 71 schools across New South Wales, Queensland and Western Australia. Over time, improvements in sleep, fruit and vegetable intake, and exercise were associated with small but significant improvements in mental health.

The reverse was also true when it came to unhealthy behaviours like screen time, junk food, alcohol use and tobacco.

A comprehensive look at adolescent lifestyles

Our new study of more than 4,400 Australian high school students looks at a suite of lifestyle behaviours: sleep, moderate-to-vigorous physical activity, sedentary (inactive) recreational screen time, fruit and vegetable intake, consumption of junk food and sugary drinks, alcohol use and smoking.

Firstly, we asked year 7 (students aged 12–13) to report their levels of these lifestyle behaviours and to rate their psychological distress (a general indicator of mental ill-health) using a well-known measurement scale.

Then we examined how changes in each of the lifestyle behaviours between year 7 and year 10 (age 15–16) were linked to psychological distress levels in year 10. Importantly, we accounted for the level of psychological distress participants reported in year 7, as well as their lifestyle behaviours in year 7. This means we can see the average benefits associated with behaviour change, no matter where people started out.

Our research showed increases over time in healthy behaviours were associated with lower psychological distress. Conversely, increases in health risk behaviours were associated with higher psychological distress.

How much makes a difference?

On average, when looking at the change between year 7 and 10, every one-hour increase in sleep per night was linked to a 9% reduction in psychological distress.

Each added day of 60 minutes of moderate-to-vigorous physical activity per week was linked to a 3% reduction in psychological distress. Each added daily serve of fruit or vegetables was linked to 4% lower psychological distress.

By contrast, each added hour of screen time was linked to a 2% increase in psychological distress, as was each unit increase in junk food or sugary drinks.

Because drinking alcohol and smoking are less common in early adolescence, we only looked at whether they had or hadn’t drank alcohol or smoked in the past six months. We saw that switching from not drinking in year 7 to drinking in year 10 was associated with a 17% increase in psychological distress. Switching from not smoking to smoking was linked to a 36% increase in psychological distress.

It’s important to note our study can’t definitively say lifestyle behaviour change caused the change in distress. The study also can’t account for changes in a student’s circumstances such as in their home life or relationships. With the baseline survey done in 2019 and the year 10 survey done in 2022, there was also the potential impact of COVID.

But our longitudinal design (tracking the same subjects over an extended period) and the way we structured the analysis does help illustrate the relationship over time.

Our study didn’t measure vaping, but evidence shows that, like smoking, it has clear links with adolescent mental health.

What does this mean for teens and parents?

National guidelines for these behaviours set out aspirational targets based on optimum health goals. But  movement guidelines  and  dietary guidelines  might seem out of reach for many teens. Indeed, most participants in our study were not meeting guidelines for physical activity, sleep, screen time, and vegetable consumption in year 10.

What our research shows is that a healthy lifestyle change doesn’t have to be all or nothing.

Even relatively small changes – getting an extra hour of sleep each night, eating one extra serve of fruit or vegetables each day, cutting out one hour of screen time, or adding an extra day of moderate-to-vigorous physical activity per week – are linked to improvements in mental health. And stacking changes in multiple areas is likely to stand you in even better stead.

Parents can play a major role in shaping lifestyle behaviours (even into the teenage years!). Expense and time can be barriers, but anything parents can do within their means is a step in the right direction.

For example,  modelling healthy social media use , making  affordable changes to your grocery shop  to improve nutritional content, or even  introducing set bedtimes . And parents can gather information so young people can make  positive choices  around alcohol, tobacco and other substance use including vaping.

The bigger picture

Lifestyle changes can support better adolescent mental health, but they’re only one piece of the puzzle. We can’t place the burden of addressing the youth mental health crisis solely on teen lifestyles. There is plenty to be done at a school, community, and policy level to create a society that supports youth mental health.

Young people who are struggling with their mental health may need professional support, which parents and carers can support them  to access . Teenagers or young people can also contact  ReachOut  or  Kids Helpline  directly for resources and support.

The article was originally published in The Conversation as "New research shows small lifestyle changes are linked to differences in teen mental health over time." written by PhD Candidate Scarlett Smout from the Matilda Centre, Katrina Champion, Senior Research Fellow & Sydney Horizon Fellow the Matilda Centre and Lauren Gardner Senior Research Fellow & Program Lead of School-Based Health Interventions, the University of Sydney. 

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Role of Physical Activity on Mental Health and Well-Being: A Review

Aditya mahindru.

1 Department of Psychiatry, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences, Wardha, IND

Pradeep Patil

Varun agrawal.

In addition to the apparent physical health benefits, physical activity also affects mental health positively. Physically inactive individuals have been reported to have higher rates of morbidity and healthcare expenditures. Commonly, exercise therapy is recommended to combat these challenges and preserve mental wellness. According to empirical investigations, physical activity is positively associated with certain mental health traits. In nonclinical investigations, the most significant effects of physical exercise have been on self-concept and body image. An attempt to review the current understanding of the physiological and psychological mechanisms by which exercise improves mental health is presented in this review article. Regular physical activity improves the functioning of the hypothalamus-pituitary-adrenal axis. Depression and anxiety appear to be influenced by physical exercise, but to a smaller extent in the population than in clinical patients. Numerous hypotheses attempt to explain the connection between physical fitness and mental wellness. Physical activity was shown to help with sleep and improve various psychiatric disorders. Exercise in general is associated with a better mood and improved quality of life. Physical exercise and yoga may help in the management of cravings for substances, especially in people who may not have access to other forms of therapy. Evidence suggests that increased physical activity can help attenuate some psychotic symptoms and treat medical comorbidities that accompany psychotic disorders. The dearth of literature in the Indian context also indicated that more research was needed to evaluate and implement interventions for physical activity tailored to the Indian context.

Introduction and background

Physical activity has its origins in ancient history. It is thought that the Indus Valley civilization created the foundation of modern yoga in approximately 3000 B.C. during the early Bronze Age [ 1 ]. The beneficial role of physical activity in healthy living and preventing and managing health disorders is well documented in the literature. Physical activity provides various significant health benefits. Mechanical stress and repeated exposure to gravitational forces created by frequent physical exercise increase a variety of characteristics, including physical strength, endurance, bone mineral density, and neuromusculoskeletal fitness, all of which contribute to a functional and independent existence. Exercise, defined as planned, systematic, and repetitive physical activity, enhances athletic performance by improving body composition, fitness, and motor abilities [ 2 ]. The function of physical activity in preventing a wide range of chronic illnesses and premature mortality has been extensively examined and studied. Adequate evidence links medical conditions such as cardiovascular disease and individual lifestyle behaviours, particularly exercise [ 3 ]. Regular exercise lowered the incidence of cardiometabolic illness, breast and colon cancer, and osteoporosis [ 4 ]. In addition to improving the quality of life for those with nonpsychiatric diseases such as peripheral artery occlusive disease and fibromyalgia, regular physical activity may help alleviate the discomforts of these particular diseases [ 5 ]. Exercise also helps with various substance use disorders, such as reducing or quitting smoking. As physical exercise strongly impacts health, worldwide standards prescribe a weekly allowance of "150 minutes" of modest to vigorous physical exercise in clinical and non-clinical populations [ 6 ]. When these recommendations are followed, many chronic diseases can be reduced by 20%-30%. Furthermore, thorough evaluations of global studies have discovered that a small amount of physical exercise is sufficient to provide health benefits [ 7 ].

Methodology

In this review article, a current understanding of the underlying physiological and psychological processes during exercise or physical activity that are implicated in improving mental health is presented. Search terms like "exercise" or "physical activity" and "mental health", "exercise" or "physical activity" and "depression", "exercise" or "physical activity" and "stress", "exercise" or "physical activity" and "anxiety", "exercise" or "physical activity" and "psychosis," "exercise" or "physical activity" and "addiction" were used as search terms in PubMed, Google Scholar, and Medline. An overwhelming majority of references come from works published within the past decade.

The impact of physical health on mental health

There is an increasing amount of evidence documenting the beneficial impacts of physical activity on mental health, with studies examining the effects of both brief bouts of exercise and more extended periods of activity. Systematic evaluations have indicated better outcomes for mental diseases with physical activity. Numerous psychological effects, such as self-esteem, cognitive function, mood, depression, and quality of life, have been studied [ 8 ]. According to general results, exercise enhances mood and self-esteem while decreasing stress tendencies, a factor known to aggravate mental and physical diseases [ 9 ]. Studies show that people who exercise regularly have a better frame of mind. However, it should be highlighted that a consistent link between mood enhancement and exercise in healthy individuals has not been established.

Additionally, human beings produce more of these two neurochemicals when they engage in physical activity. Human bodies manufacture opioids and endocannabinoids that are linked to pleasure, anxiolytic effects, sleepiness, and reduced pain sensitivity [ 10 ]. It has been shown that exercise can improve attention, focus, memory, cognition, language fluency, and decision-making for up to two hours [ 11 ]. Researchers state that regular physical activity improves the functioning of the hypothalamus-pituitary-adrenal (HPA) axis, lowering cortisol secretion and restoring the balance of leptin and ghrelin (Figure ​ (Figure1) 1 ) [ 12 ].

An external file that holds a picture, illustration, etc.
Object name is cureus-0015-00000033475-i01.jpg

HPA: hypothalamus-pituitary-adrenal

This image has been created by the authors.

Regular exercise has immunomodulatory effects such as optimising catecholamine, lowering cortisol levels, and lowering systemic inflammation. Physical activity has been shown to increase plasma brain-derived neurotrophic factor (BDNF), which is thought to reduce amyloid-beta toxicity linked to Alzheimer's disease progression [ 13 ].

Although no causal correlations have been proven, methodologically sound research has discovered a related improvement in mentally and physically ill populations. These findings are based on research and studies conducted all across the globe, particularly in the Western Hemisphere. In order to address a widespread health problem in India, it is useful to do a literature review that draws on research conducted in a variety of settings. In addition, the prevalence of these mental illnesses and the benefits of exercise as a complementary therapy might be made clear by a meta-analysis of research undertaken in India [ 14 ].

This review also analysed published literature from India to understand the effects of exercise on mental health and the implications for disease management and treatment in the Indian context. Results from Indian studies were consistent with those found in global meta-analyses. The Indian government has made public data on interventions, such as the effects of different amounts of physical exercise. Exercising and yoga have been shown to be effective adjunct therapies for a variety of mental health conditions [ 12 ]. Though yoga may not require a lot of effort to perform, other aspects of the program, such as breathing or relaxation exercises, may have an impact on a practitioner's mental health at the same time. Due to its cultural significance as a common physical practice among Indians and its low to moderate activity level, yoga would be an appropriate activity for this assessment [ 15 ].

Yoga as an adjunctive treatment 

Although yoga is a centuries-old Hindu practice, its possible therapeutic effects have recently been studied in the West. Mind-body approaches have been the subject of a lot of studies, and some of the findings suggest they may aid with mental health issues on the neurosis spectrum. As defined by the National Center for Complementary and Alternative Medicine, "mind-body interventions" aim to increase the mind's potential to alter bodily functions [ 16 ]. Due to its beneficial effects on the mind-body connection, yoga is used as a treatment for a wide range of conditions. Possible therapeutic benefits of yoga include the activation of antagonistic neuromuscular systems, stimulation of the limbic system, and a reduction in sympathetic tone.

Anxiety and depression sufferers might benefit from practising yoga. Yoga is generally safe for most people and seldom causes unintended negative consequences. Adding yoga to traditional treatment for mental health issues may be beneficial. Many of the studies on yoga included meditation as an integral part of their methodology. Meditation and other forms of focused mental practice may set off a physiological reaction known as the relaxation response. Functional imaging has been used to implicate certain regions of the brain that show activity during meditation. According to a wealth of anatomical and neurochemical evidence, meditation has been shown to have far-reaching physiological effects, including changes in attention and autonomic nervous system modulation [ 17 ]. Left anterior brain activity, which is associated with happiness, was shown to rise considerably during meditation. There's also some evidence that meditation might worsen psychosis by elevating dopamine levels [ 18 - 20 ]. We do not yet know enough about the possible downsides of meditation for patients with mental illness, since this research lacks randomised controlled trials.

Physical activity and schizophrenia

Schizophrenia is a debilitating mental disorder that often manifests in one's early years of productive life (late second decade). Remission of this disorder occurs in just a small fraction of cases. More than 60% will have relapses, and they might occur with or without noticeable deficits. Apart from delusions, hallucinations, and formal thought disorders, many patients exhibit cognitive deficits that emerge in the early stages of the disease and do not respond adequately to therapy [ 21 ].

Treatment for schizophrenia is challenging to master. Extrapyramidal side effects are a problem with first-generation antipsychotic drugs. Obesity and dyslipidemia have been related to second-generation drugs, which may cause or exacerbate these conditions. The majority of patients do not achieve complete remission, and many do not even experience satisfactory symptom relief. Even though certain antipsychotic medications may alleviate or even exacerbate negative and cognitive symptoms, these responses are far less common. This means that patients may benefit from cognitive rehabilitation. Because of their illness or a negative reaction to their medicine, they may also have depressive symptoms. This would make their condition even more disabling. Many patients also deal with clinical and emotional complications. Tardive extrapyramidal illnesses, metabolic syndromes, defect states, and attempted suicide are all in this category. Patient compliance with treatment plans is often poor. The caregivers take on a lot of stress and often get exhausted as a result.

Evidence suggests that increased physical activity can aid in attenuating some psychotic symptoms and treating medical comorbidities that accompany psychotic disorders, particularly those subject to the metabolic adverse effects of antipsychotics. Physically inactive people with mental disorders have increased morbidity and healthcare costs. Exercise solutions are commonly recommended to counteract these difficulties and maintain mental and physical wellness [ 22 ].

The failure of current medications to effectively treat schizophrenia and the lack of improvement in cognitive or negative symptoms with just medication is an argument in favour of utilising yoga as a complementary therapy for schizophrenia. Even without concomitant medication therapy, co-occurring psychosis and obesity, or metabolic syndrome, are possible. The endocrine and reproductive systems of drug abusers undergo subtle alterations. Numerous studies have shown that yoga may improve endocrine function, leading to improvements in weight management, cognitive performance, and menstrual regularity, among other benefits. In this context, the role of yoga in the treatment of schizophrenia has been conceptualized. However, yoga has only been studied for its potential efficacy as a therapy in a tiny number of studies. There might be several reasons for this. To begin with, many yoga academies frown against the practice being adapted into a medical modality. The second misconception is that people with schizophrenia cannot benefit from the mental and physical aspects of yoga practised in the ways that are recommended. Third, scientists may be hesitant to recommend yoga to these patients because of their lack of knowledge and treatment compliance.

In a randomised controlled experiment with a yoga group (n = 21) and an exercise group (n = 20), the yoga group exhibited a statistically significant reduction in negative symptoms [ 2 ]. In accordance with the most recent recommendations of the National Institute for Health and Care Excellence (NICE), the above research provides substantial evidence for the use of yoga in the treatment of schizophrenia. According to a meta-analysis of 17 distinct studies [ 23 ] on the subject, frequent physical activity reduces the negative symptoms associated with schizophrenia considerably.

Physical activity and alcohol dependence syndrome

Substance abuse, namely alcohol abuse, may have devastating effects on a person's mental and physical health. Tolerance and an inability to control drinking are some hallmarks of alcoholism. Research shows that physical activity is an effective supplement in the fight against alcohol use disorder. In addition to perhaps acting centrally on the neurotransmitter systems, physical exercise may mitigate the deleterious health consequences of drinking. Evidence suggests that persons with alcohol use disorder are not physically active and have low cardiorespiratory fitness. A wide number of medical comorbidities, like diabetes mellitus, hypertension, and other cardiovascular illnesses, occur with alcohol use disorders. Physical exercise may be highly useful in aiding the management of these comorbidities [ 24 ].

Physical exercise and yoga may help in the management of cravings for substances when other forms of therapy, such as counselling or medication for craving management are not feasible or acceptable. Physical exercise has been shown to have beneficial effects on mental health, relieve stress, and provide an enjoyable replacement for the substance. However, the patient must take an active role in physical activity-based therapies rather than passively accept the process as it is, which is in stark contrast to the approach used by conventional medicine. Since most substance use patients lack motivation and commitment to change, it is recommended that physical activity-based therapies be supplemented with therapies focusing on motivation to change to maximise therapeutic outcomes.

One hundred seventeen persons with alcohol use disorder participated in a single-arm, exploratory trial that involved a 12-minute fitness test using a cycle ergometer as an intervention. Statistically, significantly fewer cravings were experienced by 40% [ 24 ]. Exercise programmes were found to significantly reduce alcohol intake and binge drinking in people with alcohol use disorder in a meta-analysis and comprehensive review of the effects of such therapies [ 25 ].

Physical activity and sleep

Despite widespread agreement that they should prioritise their health by making time for exercise and sufficient sleep, many individuals fail to do so. Sleep deprivation has negative impacts on immune system function, mood, glucose metabolism, and cognitive ability. Slumber is a glycogenetic process that replenishes glucose storage in neurons, in contrast to the waking state, which is organised for the recurrent breakdown of glycogen. Considering these findings, it seems that sleep has endocrine effects on the brain that are unrelated to the hormonal control of metabolism and waste clearance at the cellular level. Several factors have been proposed as potential triggers for this chain reaction: changes in core body temperature, cytokine concentrations, energy expenditure and metabolic rate, central nervous system fatigue, mood, and anxiety symptoms, heart rate and heart rate variability, growth hormone and brain-derived neurotrophic factor secretion, fitness level, and body composition [ 26 ].

After 12 weeks of fitness training, one study indicated that both the quantity and quality of sleep in adolescents improved. Studies using polysomnography indicated that regular exercise lowered NREM stage N1 (very light sleep) and raised REM sleep (and REM sleep continuity and performance) [ 22 ]. As people age, both short- and long-term activities have increasingly deleterious effects on sleep. In general, both short- and long-term exercise were found to have a favourable effect on sleep quality; however, the degree of this benefit varied substantially among different sleep components. On measures of sleep quality, including total sleep time, slow-wave sleep, sleep onset latency, and REM sleep reduction, acute exercise had no effect. But both moderate and strenuous exercise has been shown to increase sleep quality [ 27 ]. According to a meta-analysis of randomised controlled trials, exercise has shown a statistically significant effect on sleep quality in adults with mental illness [ 28 ]. These findings emphasise the importance that exercise plays in improving outcomes for people suffering from mental illnesses.

Physical activity in depressive and anxiety disorders

Depression is the leading cause of disability worldwide and is a major contributor to the global burden of disease, as per the World Health Organization. However, only 10%-25% of depressed people actually seek therapy, maybe due to a lack of money, a lack of trained doctors, or the stigma associated with depression [ 29 ]. For those with less severe forms of mental illness, such as depression and anxiety, regular physical exercise may be a crucial part of their treatment and management. Exercise and physical activity might improve depressive symptoms in a way that is comparable to, if not more effective than, traditional antidepressants. However, research connecting exercise to a decreased risk of depression has not been analysed in depth [ 30 ]. Endorphins, like opiates, are opioid polypeptide compounds produced by the hypothalamus-pituitary system in vertebrates in response to extreme physical exertion, emotional arousal, or physical pain. The opioid system may mediate analgesia, social bonding, and depression due to the link between b-endorphins and depressive symptoms (Figure ​ (Figure2 2 ).

An external file that holds a picture, illustration, etc.
Object name is cureus-0015-00000033475-i02.jpg

The "endorphin hypothesis" states that physical activity causes the brain to produce more endogenous opioid peptides, which reduce pain and boost mood. The latter reduces feelings of worry and hopelessness. A recent study that demonstrated endorphins favourably improved mood during exercise, and provided support for these theories suggested that further research into the endorphin theory is required [ 31 ].

Physical activity and exercise have been shown to improve depressive symptoms and overall mood in people of all ages. Exercise has been implicated in lowering depressive and anxious symptoms in children and adolescents as well [ 32 ]. Pooled research worldwide has revealed that physical exercise is more effective than a control group and is a viable remedy for depression [ 33 ]. Most forms of yoga that start with a focus on breathing exercises, self-awareness, and relaxation techniques have a positive effect on depression and well-being [ 34 ]. Despite claims that exercise boosts mood, the optimal kind or amount of exercise required to have this effect remains unclear and seems to depend on a number of factors [ 35 ].

Exercise as a therapy for unipolar depression was studied in a meta-analysis of 23 randomised controlled trials involving 977 subjects. The effect of exercise on depression was small and not statistically significant at follow-up, although it was moderate in the initial setting. When compared to no intervention, the effect size of exercise was large and significant, and when compared to normal care, it was moderate but still noteworthy [ 36 ]. A systematic evaluation of randomised controlled trials evaluating exercise therapies for anxiety disorders indicated that exercise appeared useful as an adjuvant treatment for anxiety disorders but was less effective than antidepressant treatment [ 37 ].

Conclusions

The effects of exercise on mental health have been shown to be beneficial. Among persons with schizophrenia, yoga was shown to have more positive effects with exercise when compared with no intervention. Consistent physical activity may also improve sleep quality significantly. Patients with alcohol dependence syndrome benefit from a combination of medical therapy and regular exercise since it motivates them to battle addiction by decreasing the craving. There is also adequate evidence to suggest that physical exercise improves depressive and anxiety symptoms. Translating the evidence of the benefits of physical exercise on mental health into clinical practice is of paramount importance. Future implications of this include developing a structured exercise therapy and training professionals to deliver it. The dearth of literature in the Indian context also indicates that more research is required to evaluate and implement interventions involving physical activity that is tailored to the Indian context.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

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Nielsen-backed report finds 80% of women feel employers aren’t doing enough to support womens’ mental health at work, 3 minute read | july 2024, liptember foundation’s annual women’s mental health research report delivers crucial insights into australian womens’ mental health.

Nielsen Pacific MD speaks with The Liptember Foundation’s Head of Strategy & Operations, Katrina Locandro about the positive impact of data on womens’ health

Sydney – 15 July, 2024 – Liptember Foundation’s annual Women’s Mental Health Research Report has revealed that the most common mental health issues facing Australian women, regardless of age, are depression (46%), anxiety and generalised anxiety disorder (GAD) (41%), followed by body image issues (29%). 

The extensive research, undertaken by Nielsen custom research, also found that 25% of Australian women are likely living with a severe disorder, echoing the findings from research done by the Liptember Foundation in the prior 2 years.

It also highlights a major gap in how employers are seen to be supporting womens’ mental health in the workplace, with 80% saying, “…there’s more employers can do”. 

Meanwhile, only 45% of working women say they’re aware of the mental health services offered by their employer.

In addition, the research shows that while 54% of women say they’re currently living with mental health issues, only half of them are seeking professional help – largely due to barriers such as financial constraints, fear of social judgement, and a lack of awareness regarding available resources. 

The research also showed that 71% of women feel there isn’t a significant enough acknowledgment of mental health issues, confounded by a persistent stigma associated with seeking help, highlighting the need for better education on the issue.

Other important findings include:

  • A higher proportion of those affected with a severe disorder are likely to be under 39 years old

The 50-59 age group is most affected by depression (50%) and psychological distress (20%) compared to any other age group, where factors such as menopause, ageing, physical ailments resulting in

  •  low confidence, financial pressures and lack of societal acceptance serve as significant triggers

A notable decrease in body image issues across all ages (currently 29%), compared to 38% in 2022. There has also been a directional decline in figures for societal expectations, unrealistic ideals

  • of body image, and media pressure

CEO and Founder of Liptember, Luke Morris said: “Of remarkable note, there is a major gap in how employers are supporting womens’ mental health in the workplace. 80% feel there’s more employers can do, and only 45% of employers are known to offer mental health services. There has been a persistent blind spot when it comes to women’s mental health and the lack of research, programs, and support focused on women’s mental health is something we’re committed to improving.”

Nielsen Pacific Managing Director, Monique Perry, added: “Nielsen is proud to have worked with the Liptember Foundation over the last three years to deliver custom research with potentially life-changing impact. This year’s report highlights a need for greater awareness, education, and resources for all women, regardless of their life stage.

While data and insights can reveal unpleasant truths, they provide the opportunity to act in an informed way, ensure resources are directed where they need to be, make meaningful change, and improve the quality of life for all Australian women.”

To better understand the state of women’s mental health in Australia, download your free copy of the full report here.

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Abortion restrictions harm mental health, with low-income women hardest hit

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People living in states that enacted tighter abortion restrictions in the wake of the Dobbs v. Jackson Women’s Health decision, which returned regulation of abortion access to state legislatures , are more likely to report elevated levels of mental distress. This is particularly true for people of lower socioeconomic means.

These are the key takeaways of our July 2024 paper published in Science Advances .

We mined two years’ worth of data from the National Household Pulse Survey and analyzed 21 survey waves, each with more than 60,000 respondents. We were able to trace how newly introduced gestational restrictions and abortion bans affected mental health outcomes such as anxiety, worry, disinterest and depression on a state-by-state basis. The increase in self-reported mental health issues amounts to an approximate 3% relative rise over the pre-Dobbs baseline of 18% to 26% – a troubling increase by any measure.

Why it matters

Two years after the Dobbs decision, the country is still coming to grips with its societal repercussions. Some states have tightened restrictions on abortion , while others have taken measures to preserve access, leading thousands of women to travel across state lines each month to obtain these services. As of July 2024, 21 states have passed abortion bans or enacted more restrictive gestational limits.

The decision to overturn a half-century of legal precedent has deeply affected women’s reproductive care and is altering the legal landscape that governs people’s decisions on whether and when to have children. These decisions are often stressful, as they involve navigating complex emotional, social and legal landscapes.

Accordingly, these sudden changes in access to abortion services may carry significant mental health consequences. Breaking down our results by demographic, we found consistent effects across birth-assigned gender, sexual orientation, age, marital status and race. However, we also found striking differences dependent on respondents’ income level and education.

Put plainly, abortion restrictions had a greater negative impact on the mental health of respondents of lesser economic means and the less educated. Those with more wealth and education, by contrast, were largely insulated.

As more states consider adopting restrictions of their own, with possible federal restrictions on abortion not off the table , it helps to have a more holistic sense of what that might mean for Americans.

In addition, our study underscores the need to think about women’s health across various subgroups of the population, especially as it pertains to sex assigned at birth and socioeconomic class.

What still isn’t known

We do not know exactly why socioeconomic class played such a pivotal role in our study, but we can speculate.

One possible explanation has to do with anticipatory stress about the financial burdens associated with carrying an unwanted pregnancy to term, or traveling out of state for an abortion. Financial concerns of this sort are likely more impactful on the mental health of Americans who are least able to bear these costs.

An alternative theory is that poorer women constitute a disproportionate percentage of the patient base receiving abortion care. According to a 2014 report from the Guttmacher Institute, an advocacy group, 75% of abortion patients qualified as low-income .

What other research is being done

Our work builds on findings from The Turnaway Study, which observed a marked decline in the short-term mental health of women who were denied an abortion because their pregnancy just exceeded the gestational limit. Our unique contribution resides in assessing the effect of abortion restrictions on mental health more broadly.

It’s important to realize that this paper is part of a growing body of work that shows the issues with mental health in the post-Dobbs era. Some studies have looked exclusively at women while others have begun to compare younger men and women . Whereas those works found effects were concentrated primarily among women of childbearing age, our results imply that a broader swath of the population has been affected.

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Can encouraging substance abuse patients to participate in self-help groups reduce demand for health care? A quasi-experimental study

Affiliation.

  • 1 Veterans Affairs Palo Alto Health Care System, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California 94025, USA. [email protected]
  • PMID: 11371720

Background: Twelve-step-oriented inpatient treatment programs emphasize 12-step treatment approaches and the importance of ongoing attendance at 12-step self-help groups more than do cognitive-behavioral (CB) inpatient treatment programs. This study evaluated whether this difference in therapeutic approach leads patients who are treated in 12-step programs to rely less on professionally provided services and more on self-help groups after discharge, thereby reducing long-term health care costs.

Methods: A prospective, quasi-experimental comparison of 12-step-based (N = 5) and cognitive-behavioral (n = 5) inpatient treatment programs was conducted. These treatments were compared on the degree to which their patients participated in self-help groups, used outpatient and inpatient mental health services, and experienced positive outcomes (e.g., abstinence) in the year following discharge. Using a larger sample from an ongoing research project, 887 male substance-dependent patients from each type of treatment program were matched on pre-intake health care costs (N = 1774). At baseline and 1-year follow-up, patients' involvement in self-help groups (e.g., Alcoholics Anonymous), utilization and costs of mental health services, and clinical outcomes were assessed.

Results: Compared with patients treated in CB programs, patients treated in 12-step programs had significantly greater involvement in self-help groups at follow-up. In contrast, patients treated in CB programs averaged almost twice as many outpatient continuing care visits after discharge (22.5 visits) as patients treated in 12-step treatment programs (13.1 visits), and also received significantly more days of inpatient care (17.0 days in CB versus 10.5 in 12-step), resulting in 64% higher annual costs in CB programs ($4729/patient, p < 0.001). Psychiatric and substance abuse outcomes were comparable across treatments, except that 12-step patients had higher rates of abstinence at follow-up (45.7% versus 36.2% for patients from CB programs, p < 0.001).

Conclusions: Professional treatment programs that emphasize self-help approaches increase their patients' reliance on cost-free self-help groups and thereby lower subsequent health care costs. Such programs therefore represent a cost-effective approach to promoting recovery from substance abuse.

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NIMH Clinical Research Toolbox

NIMH Clinical Research Toolbox

The NIMH Clinical Research Toolbox serves as an information repository for NIMH staff and the clinical research community, particularly those receiving NIMH funding. The Toolbox contains resources such as NIH and NIMH policy and guidance documents, templates, sample forms, links to additional resources, and other materials to assist clinical investigators in the development and conduct of high-quality clinical research studies.

Use of these templates and forms is optional; the resources can be used as-is or customized to serve study team needs. In cases where institutions provide research teams with institution-specific templates and forms for clinical research documentation, NIMH expects researchers to follow their institutional policies for document use. Nevertheless, the materials on this page can be consulted to assure that study teams are meeting NIMH expectations.

Protocol Templates

Protocol associated documents, regulatory documents and associated case report forms, clinical research education, support, and training (crest) program overview.

  • Human Subject Risk

Data and Safety Monitoring for Clinical Trials

Reportable events, recruitment, suicide prevention research, good clinical practice training, data sharing, educational presentations, clinical research start up.

NIMH encourages investigators to consider using one of the protocol templates below when developing a clinical research protocol. In cases where an institutional review board (IRB) has a recommended or required protocol template, reviewing the documents included below is still suggested as there may be sections that a study team may opt to include in an effort to develop a comprehensive research protocol.

NIH has developed a Clinical e-Protocol Writing Tool  to support the collaborative writing and review of protocols for behavioral and social sciences research involving humans, and of phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application.

NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template  

This clinical trial protocol template is a suggested format for Phase 2 and 3 clinical trials funded by NIH that are being conducted under a FDA IND or IDE Application.

Investigators for such trials are encouraged to use this template when developing protocols for NIH-funded clinical trial(s). This template may also be useful to others developing phase 2 and 3 IND/IDE clinical trials.

NIH Behavioral and Social Clinical Trials Template  

This clinical trial protocol template is a suggested format for behavioral or psychosocial clinical trials funded by NIH. Investigators for such studies are encouraged to use this template when developing protocols for NIH-funded clinical trial(s). This template may also be useful to others developing behavioral of psychosocial research studies.

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NIMH Clinical Manual of Procedures (MOP) Template [Word]

This template provides a recommended structure for developing consistent instructions on study procedure implementation and data collection across participant and clinical site activities. It details the study’s organization, operations, procedures, data management, and quality control.

NIMH Clinical Monitoring Plan Template [Word]

This template provides a recommended structure for a plan to conduct internal or independent review of Good Clinical Practices (GCP), human subject safety, and data integrity throughout the lifecycle of a study.

Informed Consent Materials

Often study teams will be provided with informed consent form templates and guidance on requirements for the informed consent process by their institutions. Below is additional guidance and materials to support a thorough informed consent process.

Sample NDA Informed Consent Language

The NIMH Data Archive (NDA) receives de-identified human subjects data collected from hundreds of research projects across many scientific domains, and makes these data available to enable collaborative science. This NDA sample informed consent language for data sharing can be adapted when using one of the NDA platforms.

Regulatory Document Checklists by Study Type The following checklists are intended to help the investigator community identify a set of core documents to be organized within a single study specific folder, either electronically, hard copy, or a mixture of both formats. NIMH encourages study teams to verify what additional documents, or alternative formats of the documents in the checklists, their institution and IRB require.

NIMH Regulatory Document Checklist for non-Clinical Trial Human Subjects Research [Word]

Study teams can use this checklist to compile essential documents for the conduct of a NIMH-funded study that does not meet the NIH definition of a clinical trial  and is research on human subjects.

NIMH Regulatory Document Checklist for Clinical Trials without Investigational Product [Word]

Study teams can use this checklist to compile essential documents for the conduct of a NIMH-funded NIH defined clinical trial  that does not involve an investigational drug or device.

NIMH Regulatory Document Checklist for Human Subjects Research Clinical Trials with Investigational Product not under a FDA IND/IDE [Word]

Study teams can use this checklist to compile essential documents for the conduct of a NIMH-funded NIH defined clinical trial  with an investigational drug or device that is not under a FDA IND or IDE.

NIMH Regulatory Document Checklist for a Study under a FDA IND or IDE [Word]

Study teams can use this checklist to compile essential documents for the conduct of a NIMH-funded NIH defined clinical trial  or non-clinical trial with an investigational drug or device under a FDA IND or IDE.

Necessary Documents for Reportable Events

NIMH Reportable Events Log Template [Word]

This document provides a log template for documenting reportable events. The types of events that require reporting may vary by institution, IRB, sponsor, state, and other factors.

NIMH Study-Wide Protocol Deviation Log Template [Word]

This document provides a log template for tracking all protocol deviations/violations across a study.

NIMH Subject-Specific Protocol Deviation Log Template [Word]

This document provides a log template for tracking subject-specific protocol deviations/violations. If captured electronically, subject-specific deviation logs can be exported into a study-wide deviation log.

NIMH Study-Wide Adverse Events (AE) Log Template [Word]

This document provides a log template for tracking all adverse events (AEs), including serious adverse events (SAEs), across a study.

NIMH Subject-Specific Adverse Event (AE) Log Template [Word]

This document provides a log template for tracking adverse events (AEs), including serious adverse events (SAEs), for each subject. If captured electronically, subject-specific AE logs can be exported into an electronic study-wide AE log.

Necessary Documents for Studies with Pharmacy/Investigational Product

FDA Form 1572 Statement of Investigator  

This FDA form should be signed by the investigator prior to study initiation to provide certain information to the sponsor, and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic.

NIMH Investigational Product (IP) Management Standard Operating Procedure (SOP) Template [Word]

This document provides a sample standard operating procedures (SOP) template to document how investigational product (IP) will be received, stored, monitored, labeled, dispensed, and destroyed.

NIMH Investigational Product Storage Temperature Log Template [Word]

This document provides a log template for recording the daily temperatures for investigational product (IP).

NIMH Master Investigational Product Dispensing and Accountability Log Template [Word]

This document provides a log template for capturing all investigational product (IP) dispensed to and returned by participants for the duration of the study.

NIMH Subject-Specific Investigational Product Dispensation and Accountability Log Template [Word]

This document provides a log template for capturing all investigational product (IP) dispensed to an individual participant and returned by that participant. This log is typically placed in each subject’s study binder (study blind is maintained, if applicable).

Screening and Enrollment Logs and Materials

NIMH Participant Pre-Screening Log Template [Word]

This document provides a log template for all potential participants who have completed initial screening procedures (i.e. phone screens or internet screening surveys; typically, prior to signing written informed consent). This log should capture the number of participants eligible for an official screening visit, as well as the number ineligible with the reasons for ineligibility listed.

NIMH Participant Enrollment Log Template [Word]

This document provides a log template for chronologically documenting the participants who have been enrolled in the study.

NIMH Inclusion/Exclusion Checklist Template [Word]

This document provides a sample checklist to customize according to protocol-specific eligibility criteria. A qualified and appropriately-delegated study team member should sign and date to confirm eligibility once all criteria have been assessed. If criteria are assessed on different visit dates, this checklist should be reformatted to reflect which criteria are assessed on which visit dates, and who is responsible for assessing them.

NIMH Documentation of Informed Consent Template [Word]

This document provides a sample form template for documenting the informed consent process.

Additional Participant Tracking Logs and Materials

NIMH Concomitant Medication Log Template [Word]

This document provides a log template for recording each participant’s medications throughout the study. This log is typically reviewed at all subject study visits and is located in each participant’s study binder.

NIMH Research Sample Inventory/Tracking Log [Word]

This document provides a log template for tracking the collection and storage of research samples.

Staff Training and Administrative Tracking Logs and Materials

NIMH Good Clinical Practice (GCP) Training Log Template [Word]

This document provides a log template for documenting completion of Good Clinical Practice (GCP) training requirements. Note: all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). Individual institutions may require GCP training regardless of funding source or clinical trial status.

NIMH Study Training Log Template [Word]

This document provides a log template for documenting staff trainings for study-specific procedures (i.e., trainings for diagnostic interview administration, study protocol adherence, phlebotomy, outcomes measures, OSHA Bloodborne Pathogens, etc.).

NIMH Delegation of Authority Log Template [Word]

This document can be used to record all study staff members’ significant study-related duties, as delegated by the Principal Investigator (PI). Most studies opt to use a log format, such as the Delegation of Authority log, because it captures study staff on one page and includes space to document the addition or removal of specific study tasks for individual staff members.

NIMH Monitoring Visit Log Template [Word]

This document is typically completed by the clinical site monitor to document dates and purpose of clinical site monitoring visits.

NIMH Note to File (NTF) Template [Word]

This document provides a sample template for generating notes-to-file, which are written to acknowledge a discrepancy or problem with the study’s conduct, or for other administrative purposes (such as to document where study materials are stored).

On-Site Monitoring

Even though it is the NIMH’s expectation that grantees will provide adequate oversight of their clinical research, NIMH Program Officials may require additional levels of on-site monitoring conducted by NIMH staff. Clinical monitoring helps ensure the rights and well-being of human subjects are protected; the reported clinical research study data are accurate, complete, and verifiable; and the conduct of the study is in compliance with the study protocol, Good Clinical Practice (GCP), and the regulations of applicable agencies.

The NIMH Clinical Research Education, Support, and Training (CREST) Program provides ongoing educational and technical support from NIMH staff for clinical research project grants selected for consultation and/or site visit(s). The CREST Program aims to ensure that the reported clinical research study data are accurate, complete, and verifiable, the conduct of the study is in compliance with the study protocol, Good Clinical Practice (GCP) and the regulations of applicable agencies, and the rights and well-being of human subjects are protected, in accordance with 45 CFR 46 (Protection of Human Subjects) and, as applicable, 21 CFR part 50 (Protection of Human Subjects).

To promote clinical research that is compliant with GCP and human subject regulations, the CREST Program includes phone conversations, email consultation, and/or site visit(s) from NIMH staff, as needed, to assess and provide written feedback and recommendations on planned or ongoing clinical research protocols. Documents relating to the conduct of the clinical research, such as current IRB approved protocols, informed consent documents, source documents, and drug accountability records, as applicable, may be reviewed for compliance with applicable Federal regulations, and institutional and IRB policies.

Research project grants selected for inclusion in the CREST Program might include clinical research studies with “significantly-greater-than-minimal risk” to subjects (e.g., an intervention or invasive procedure with high potential for serious adverse events; see NIMH Risk-Based Monitoring Guidance ); a study intervention under a FDA Investigational New Drug or Investigational Device Exemption; or other studies identified by NIMH staff that may benefit from inclusion in CREST. CREST is separate and distinct from “for cause” audits of clinical research. Research grants may be included in CREST at any time during the study lifecycle, although projects are generally identified and selected for the program at the initiation of the grant.

NIMH Clinical Research Education Support and Training (CREST) Program Overview

This page provides a description of the NIMH CREST Program’s purpose, process for inclusion, and operating procedures.

Site Visits

NIMH Clinical Research Education, Support, and Training Program (CREST): Comprehensive Visit Report Template [Word]

This template provides a recommended structure for a CREST site visit report, as well as a sample matrix of regulatory criteria that CREST monitors look at while at site initiation visits (SIVs), interim monitoring visits (IMVs) and close out visits (COVs). It is to be used as a starting point for preparing for a CREST site visit or for writing a site visit report.

NIMH CREST Site Initiation Visit (SIV) Sample Agenda [Word]

This document provides a sample site initiation visit agenda to be customized by the Principal Investigator (PI) and site monitor prior to the visit.

Human Subjects Research

This section provides resources, including policy and guidance documents related to the conduct of human subject research. The resources included below represent those frequently of interest to NIMH investigators, specifically: overviews of human subject research, data and safety monitoring, human subject risk, reportable events, and recruitment. There are numerous other NIH webpages devoted to human subjects research; see Research Involving Human Subjects  , NIH Human Subjects Policies and Guidance  , and New Human Subjects and Clinical Trial Information Form  .

Human Subject Regulations Decision Charts 

The Office for Human Research Protections (OHRP) has developed graphic aids to help guide investigators in deciding if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations ( 45 CFR 46  ).

Human Subjects in Research: Things to Consider

This NIMH webpage presents items which investigators should pay particular attention to when proposing to use human subjects in NIMH-funded studies.

Human Subjects Risk

NIMH Guidance on Risk-Based Monitoring

This NIMH guidance aims to clarify risk level definitions and the NIMH’s monitoring expectations to mitigate these risks. This guidance will assist study teams in determining the level of data and safety monitoring that should be established for a study based on the probability and magnitude of anticipated harm and discomfort.

The policies, guidance and documentation in this section outline NIMH expectations for data and safety monitoring of clinical trials  . For human subject research that does not meet criteria for NIH clinical trial designation, investigators still have an option of including a data and safety monitoring plan (DSMP; i.e., in studies that may have significant risk to participants). The initial links below apply to all NIMH-funded clinical trials, while the second section provides documentation for clinical trials under the oversight of a NIMH-constituted data and safety monitoring board (DSMB).

All Clinical Trials

NIMH Policy Governing the Monitoring of Clinical Trials

This NIMH policy outlines NIH and NIMH expectations for data and safety monitoring of clinical trials. This policy also assures that the NIMH is notified by NIMH-funded researchers in a timely manner of all directives emanating from monitoring activities.

Guidance for Developing a Data and Safety Monitoring Plan for Clinical Trials Sponsored by NIMH

This guidance was created to aid investigators developing a data and safety monitoring plan (DSMP) to ensure the safety of research participants and to protect the validity and integrity of study data in clinical trials supported by NIMH. This guidance applies to data and safety monitoring for all NIMH-supported clinical trials (including grants, cooperative agreements, and contracts).

NIMH Policy Governing Independent Safety Monitors and Independent Data and Safety Monitoring Boards

This policy establishes expectations for the monitoring of NIMH-supported clinical trials by Independent Safety Monitors (ISMs) and/or independent data and safety monitoring boards (DSMBs) to assure the safety of research participants, regulatory compliance, and data integrity.

Trials Reviewed by a NIMH-Constituted DSMB

The materials below are for studies designated for review by a NIMH-constituted DSMB. Study teams developing materials for a study-constituted independent DSMB may benefit from reviewing the data report template and the protocol amendment memo.

NIMH Clinical Trials Operations Branch Liaison Orientation Letter [Word]

This letter provides an orientation to working with the NIMH Clinical Trials Operations Branch which supports study teams reporting to the NIMH DSMB.

NIMH DSMB Reporting Guide Full Report Template [PDF]

This template provides a recommended structure for data reports used for DSMB review and oversight. The report template includes standard data tables. Study teams are encouraged to utilize this template as a starting point, and use, remove, and/or modify the existing tables as appropriate for the study under review.

NIMH DSMB Amendment Memo Template [Word]

This template may be used when submitting a study protocol or consent document amendment to the NIMH DSMB.

NIMH Reportable Events Policy

This policy outlines the expectations of NIMH-funded researchers relating to the submission of reportable events (i.e., Adverse Events  (AEs); Serious Adverse Events  (SAEs); Unanticipated Problems Involving Risks to Subjects or Others  ; protocol violations; non-compliance  (serious or continuing); suspensions or terminations by monitoring entities  (i.e., Institutional Review Board (IRB), Independent Safety Monitor (ISM)); and suspensions or terminations by regulatory agencies (i.e., Office for Human Research Protections  (OHRP) or the Food and Drug Administration (FDA)).

( For associated documentation, see: Guidance on Regulatory Documents and Associated Case Report Forms )

NIMH Policy for the Recruitment of Participants in Clinical Research

This policy is intended to support effective and efficient recruitment of participants into all NIMH extramural-funded clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size.

NIMH Recruitment of Participants in Clinical Research Policy

This policy outlines NIMH expectations regarding the establishment of recruitment plans and milestones for overall study enrollment, and as appropriate, recruitment plans for females and males, members of racial and ethnic minority groups, and children, as well as recruitment reporting.

Frequently Asked Questions (FAQ) about Recruitment Milestone Reporting (RMR)

This NIMH FAQ document provides responses to several of the most common questions surrounding RMR.

Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study

These “points to consider” are meant to serve as a resource as investigators plan a clinical research study and a NIMH grant application. It also outlines common barriers that can impact clinical recruitment and retention.

Additional Resources and Trainings

Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers

This web document is intended to support the development of NIMH research grant applications in suicide research, including those related to clinical course, risk and detection, and interventions and implementation, as well as to support research conduct that is safe, ethical and feasible.

Based on the NIH Good Clinical Practice (GCP) policy  , all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials are requirement to be trained in GCP. Below are links to some GCP courses that meet NIH GCP training expectations.

Good Clinical Practice for Social and Behavioral Research – E-Learning Course 

The NIH Office of Behavioral and Social Sciences Research (OBSSR) offers a self-paced Good Clinical Practice (GCP) training course with nine video modules. Learners complete knowledge checks and exercises throughout the course.

National Institute of Allergies and Infectious Diseases (NIAID) GCP Learning Center 

NIAID has created a self-paced Good Clinical Practice (GCP) training course that includes four modules. These modules educate the learner on the history of human subject research, the regulatory framework, planning human subject research, and conducting human subject research.

National Drug Abuse Treatment (NDAT) Clinical Trials Network  

This NDAT course includes 12 modules based on International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and the Code of Federal Regulations (CFR) for clinical research studies in the U.S. The course is self-paced and takes approximately six hours to complete.

The following notices and links present NIMH expectations and tools for data sharing.

Data Sharing Expectations for NIMH-Funded Clinical Trials 

This notice establishes NIMH’s data sharing expectations, including the request to include a detailed data sharing plan as part of grant applications.

Data Harmonization 

This notice encourages investigators in the mental health research community to utilize data collection protocols using a common set of tools and resources to facilitate sharing, comparing, and integration of data from multiple sources.

NIMH Data Archive 

The NIMH Data Archive is an informatics platform for the sharing of de-identified human subject data from all clinical research funded by the NIMH.

Educational Materials

The following educational materials are provided to support the training of NIMH-funded clinical research investigators and staff.

Good Clinical Practices (GCP) for NIMH-Sponsored Studies [PowerPoint]

This training presentation defines Good Clinical Practice (GCP) and describes its application in NIMH-funded research. Topics include: investigator responsibilities, training and qualifications, resources and staffing, delegation of responsibilities, informed consent, documentation and storage of data, assessment and reporting, protocol adherence, drug accountability, adverse events/unanticipated problems and noncompliance. Note that this presentation does not replace the Good Clinical Practice (GCP) training required for NIH funded investigators.

Good Documentation Practices for NIMH-Sponsored Studies [PowerPoint]

This training presentation provides an overview of good documentation practices to follow throughout the duration of NIMH-funded research. The presentation defines and gives examples of good documentation practices.

Introduction to Site-Level Quality Management for NIMH-Sponsored Studies [PowerPoint]

This training presentation provides an overview of the process of establishing and ensuring the quality of processes, data, and documentation associated with clinical research activities. Quality Management (QM) is defined in relationship to site-level documentation, processes, and activities. Tools that are available to support site-level QM are also described.

NIMH Clinical Monitoring and Clinical Research Education, Support, and Training Program (CREST) Overview [PowerPoint]

This training presentation provides an overview of Clinical Monitoring, types of site monitoring visits and what takes place during these visits as well as an overview of follow-up activities. The presentation specifically describes the NIMH Clinical Research Education Support and Training (CREST) Program, its goals, study portfolio selection process, and standard procedures.

Additional NIMH Links and Contacts:

  • Office of Clinical Research
  • Clinical Trials Operations Branch (CTOB)
  • NIMH Clinical Research Policies, Guidance, and Resources
  • Human Research Protection Branch (HRPB)
  • Open access
  • Published: 09 July 2024

“If you’re struggling, you don’t really care” – what affects the physical health of young people on child and adolescent mental health inpatient units? A qualitative study with service users and staff

  • Rebekah Carney 1 , 2 ,
  • Shermin Imran 3 ,
  • Heather Law 1 ,
  • Parise Carmichael-Murphy 1 , 2 ,
  • Leah Charlton 1 , 2 &
  • Sophie Parker 1 , 2  

BMC Psychiatry volume  24 , Article number:  498 ( 2024 ) Cite this article

158 Accesses

Metrics details

Physical health inequalities of people with serious mental illness (SMI) have been labelled an international scandal; due to the 15–20-year reduction in life expectancy associated with poor physical health. This occurs at an early stage and evidence shows young people with and at risk for SMI are a particularly vulnerable group requiring intervention and support. However, most work has been conducted with adults and little is known about what affects physical health for young people, specifically those receiving inpatient care.

We conducted semi-structured qualitative interviews with 7 service users and 6 staff members (85% female, age 14–42) on a generic mental health inpatient unit for children and adolescents. Interviews aimed to identify how young people viewed theirphysical health and factors affecting physical health and lifestyle and identify any support needed to improve physical health. Thematic analysis was conducted. .

Thematic analysis revealed the main factors affecting physical health and lifestyle for young people. Three main themes were individual factors (subthemes were mental health symptoms, knowledge, attitudes and beliefs), environmental factors (subthemes were opportunities in a restricted environment and food provision), and the influence of others (subthemes were peers, staff, family members). These factors often overlapped and could promote a healthy lifestyle or combine to increase the risk of poor physical health. Young people discussed their preferences for physical health initiatives and what would help them to live a healthier lifestyle.

Conclusions

Promoting physical health on inpatient units for young people is an important, yet neglected area of mental health research. We have identified a range of complex factors which have an impact on their physical health, and there is a pervasive need to address the barriers that young people experience to living a healthy lifestyle. There is an increasingly strong evidence base suggesting the benefits of physical health interventions to improve outcomes, and future work should identify ways to implement such interventions considering the barriers discussed in this article. Further collaborative research is needed with young people, clinical teams, caregivers, and commissioners to ensure improvements are made to clinical care provision and optimisation of the inpatient environment.

Peer Review reports

The poor physical health of people with serious mental illness (SMI) has long been established. People with SMI experience significant physical health inequalities compared with the general population [ 1 , 2 , 3 ]. A 15–20-year mortality gap arises from an increased risk of developing non-communicable diseases such as diabetes and obesity, increased likelihood of engaging in behaviours which produce adverse health outcomes, reduced access to and provision of physical health care, and medication side effects [ 1 , 2 , 4 ]. This has been labelled an international ‘human rights scandal’ as much of this risk is preventable [ 5 ]. Various national and international health bodies have responded by producing guidelines to reduce the incidence and impact of physical comorbidities in people with SMI. Recommendations include increased access to physical health interventions, implementation of exercise initiatives across clinical settings and improving detection, monitoring, and treatment of physical health [ 3 , 4 , 6 , 7 ].

Children and young people with SMI and/or those receiving treatment from mental health services are particularly vulnerable, requiring additional support to look after their physical health and wellbeing. They are more likely to engage in adverse health behaviours such as smoking, less likely to be physically active and consume a balanced diet [ 8 , 9 , 10 , 11 ]. Individuals on child and adolescent mental health service (CAMHS) inpatient units are particularly at risk for poor physical health, given their restricted living environment, high levels of psychological distress and likelihood of being prescribed antipsychotic medication [ 12 , 13 , 14 ]. Our recent meta-analysis of international studies found almost half of young people on CAMHS inpatient units were overweight or obese, and over half smoked tobacco. Concerningly, they also showed early signs of metabolic risk and metabolic syndrome, and high levels of modifiable risk including low levels of physical activity [ 9 ]. Although there is increasing evidence to show physical health problems are common in young people with SMI or those receiving CAMHS mental health care, they often go undetected or untreated, and existing guidelines can be unclear or not child focused [ 10 , 15 ]. Therefore, physical health care is often inconsistent, with staff often lacking clarity over whether it should be their responsibility, meaning more research is needed to optimise physical healthcare.

Despite extensive evidence promoting the use of physical health interventions for adults with SMI [ 3 , 16 , 17 ] there is a paucity of research for young people, particularly in inpatient settings, and little work has been done with a physical health focus in this setting. Our recent systematic review revealed very few physical health interventions had been conducted on CAMHS inpatient units and little is known about the feasibility of implementing such interventions in inpatient settings [ 14 , 18 ]. However, studies that do exist suggest physical health interventions can improve social functioning, physical health outcomes and quality of life [ 14 , 18 , 19 , 20 , 21 ]. More research is needed to inform policy and practice to improve care provision and identify acceptable ways for implementation in inpatient units. Previous qualitative work with young people with SMI (and those at-risk for SMI) have investigated the barriers and facilitators to living a healthy lifestyle [ 22 , 23 , 24 ]. Various psychological barriers such as poor self-efficacy, anxiety and low motivation are often reported, as well as practical issues such as access and financial implications [ 25 ]. Young people on inpatient units may also experience these barriers, however, the inpatient environment, despite presenting a unique opportunity to intervene, may pose additional difficulties that need to be considered prior to designing and implementing physical health initiatives.

Through qualitative interviews with service users and staff, we aimed to identify:

How young people view their physical health when on CAMHS inpatient units.

Factors affecting physical health and lifestyle for young people on CAMHS inpatient units.

Support that would be useful to help young people on CAMHS inpatient units improve their physical health.

This study was reported according to Standards for Reporting Qualitative Studies (SPRQ [ 26 ]). Approvals were granted by North-West and Greater Manchester East Ethics Committee (ref:19/NW/0458; August 2019).

The study took place within CAMHS inpatient services at Greater Manchester Mental Health NHS Foundation Trust (GMMH NHS FT). The service consists of a 20-bed mixed-gender, adolescent inpatient unit for young people with complex health needs. Individuals are admitted to the unit with severe or acute mental health symptoms meaning they are unable to keep themselves safe. Referrals are received via CAMHS or adult mental health services treating adolescents aged 13–18 years whose needs cannot be met safely within the community, who have a range of diagnoses and mental health needs and experience high levels of psychological distress. Evidence based treatments are provided in line with National Institute for Health and Care Excellence (NICE) guidelines and individuals have access to a range of psychological therapies (individual/group), occupational therapy-based activities and family interventions.

Participants

Convenience sampling was used. Eligible service users were aged 14–18 and had received inpatient care within the service for at least two weeks. Service users who did not have capacity to consent, had a primary diagnosis of an eating disorder or who had language/communication difficulties were excluded. All potentially eligible participants were given the opportunity to be involved. All staff members were approached who had worked within the service for longer than two weeks. At least two weeks’ experience of the inpatient ward was required to ensure participants had insight into the factors affecting physical health.

Staff were approached at team meetings and through clinical networks with the research team. Staff members were also informed of the inclusion criteria for service users and given information leaflets to give to any potentially eligible participants and obtain consent to contact. Researchers met with any eligible participants to discuss the study and answer any questions. Written informed consent was sought prior to the interview. Service users were reimbursed for their time with a £10 voucher.

Demographics and sampling

Age, gender, ethnicity, diagnoses, length of stay (service users) and job role (staff) were obtained using a purpose-built demographic form.

Thirteen participants were interviewed ( n  = 7 service users; n  = 6 staff), See Table  1 for demographics.

Qualitative interviews

A qualitative design was employed using semi-structured interviews. Topic guides were developed by the study team based on previous research and consultations with young people within the service [ 15 , 27 ] (topic guides available on request). Semi-structured interviews were conducted by the lead author and psychiatrist within the clinical service. They covered a range of pre-specified topics about physical health for young people within the service. This included questions about diet, exercise, and physical health care. They were also asked about barriers and facilitators to living a healthy lifestyle on inpatient mental health units, as well as their beliefs about physical health, and what would help promote physical health in the inpatient environment. The interview schedules were adapted to staff and service users and lasted approximately 1-hour. Interview guides were flexible, used prompts and open-ended questions to encourage participants to talk in-depth about their experiences. Interviews were recorded on an encrypted dictaphone and transcribed verbatim for analysis. Pseudonyms were used to maintain anonymity.

Qualitative analysis

There were some pre-specified areas of interest which included identifying the main barriers and facilitators to living a healthy lifestyle on inpatient mental health units, and how to optimise physical health care. This means that we aimed to identify the main themes in these areas which came from the data. Thematic analysis was conducted on the transcripts to analyse the data. Thematic analysis is a systematic approach whereby patterns and common themes are identified to describe a data set and understand more about a given phenomenon [ 28 ]. An inductive approach was adopted to identify common themes in the data, according to Braun and Clarke’s (2006) method which was conducted as follows:

Transcripts were read and re-read by researchers until they were familiar with the data and could anticipate what the respondent would say next.

Researchers systematically coded line by line to identify common features in the data.

Codes were reviewed to determine potential themes.

Themes were reviewed through discussion for internal homogeneity and external heterogeneity and ensure they were distinctive and rational.

Themes were defined and named.

All researchers were involved in the analytic process, and transcripts were coded individually by multiple researchers. Data analysis was conducted using nVivo (Version 12, Qualitative Data Analysis Software, 2015). Several processes were followed to ensure trustworthiness. Credibility was achieved by researchers adhering to a set protocol and following the rigorous methods as described by Braun and Clarke above. Themes and codes were discussed throughout, as well as how authors predispositions may be affecting decisions about codes and themes and all discrepancies were resolved through discussion to ensure confirmability. Quotes are presented within the results section to illuminate findings and add context to themes. Codes from the two groups were synthesized to identify overarching themes. To ensure transferability a detailed description of the service and setting has been reported and people with clinical expertise and knowledge of CAMHS were involved in the analytic process to ensure validity.

Factors affecting physical health

A wide range of factors affecting physical health were discussed. They could be broken down into three themes: “Individual Factors”, “Environment”, and “Influence of Others”. See Table  2 for supporting quotes, and Fig.  1 for a descriptive diagram.

figure 1

Factors affecting physical health of young people on CAMHS inpatient units

Individual factors

The first theme was ‘Individual Factors’ which was defined as anything that was associated with the young person as an individual and linked to their personal experiences. This was broken down into specific subthemes such as their current mental health, knowledge, attitudes and beliefs.

Current mental health symptoms

Current mental health symptoms had a major impact on physical health and lifestyle. Symptoms of depression such as low motivation, apathy/disinterest, and a preference to stay in their rooms affected physical activity levels.

YP4:“sometimes I just you know, just can’t get out of bed and don’t want to do anything.

They described feeling anxious, particularly in a social group, and preferring to be alone. Social withdrawal was common and meant they sometimes avoided group activities such as running/walking/smoothie making.

Staff discussed direct links between mental health and physical health, via side effects of medication. The theme of weight gain was prominent, with staff attributing this to metabolic side effects such as “increased appetite” and “sedative effects” reducing energy and motivation. Young people also reported gaining weight since being on the unit, that medication “makes you really hungry” , and that they were more self-conscious, and unhappy with their appearance.

ST6:“one of the lads currently he is on medication which increases his hunger, and he is saying like I’m eating 8 loads of bread in between dinner and supper… and he is quite paranoid about putting on weight.

Knowledge, attitudes and beliefs

Young people were aware of some of the benefits of living a healthy lifestyle (exercising and eating a balanced diet). They reflected on personal positive impacts such as improved mood, “feeling so much better and having a lot more energy”YP3 . Yet, achieving this was difficult, and they described many barriers to doing so including feeling unable to live a healthy lifestyle. When asked about their understanding, many referred to exercising, eating a balanced diet, getting enough sleep, and avoiding smoking and alcohol use. However, descriptions were often vague, and some struggled to provide examples. This was reinforced by staff who claimed that young people had basic knowledge and skills (e.g., ability to cook a meal), but less awareness of the importance of a healthy lifestyle.

ST4:“I think it’s the lack of knowledge about food actually, you know what, it’s what sort of it is really you know as opposed to yeah, I just fancy that, or well I didn’t eat anything yesterday, so I can have 6 cheeseburgers today… that unfortunately I do see that mentality in a lot of them.”

Young people expressed their preferences for a dynamic approach to exercise, with a variety of options (e.g., groups such as yoga, netball, football). Making sure activities were accessible for everyone was also important, via an individualized approach based on “ what people love and enjoy” and activities that “make it look fun and easy” so anyone can take part. There was also a desire from both young people and staff to pursue activities that improve their knowledge and skills, and promote autonomy over their physical health.

YP4:“how to cook healthier meals…. what kind of exercises are the best”. YP3:“run some like training like first aid, like little programmes for young people to do, so that we can like take charge of our own and maybe like might know how to manage our own physical health”.

Physical health was viewed as less important than their mental health. Although many acknowledged they could be doing more, physical health was not described as being “at the top of their priorities” and young people claiming “ if you’re struggling you don’t really care ”. Similarly, other activities held higher value, such as engaging in social activities or leaving the ward (including “ the cinema ” or “ bowling ”).

Environmental factors

The second theme was ‘Environmental Factors’ which was defined as anything that affected young people as a direct result of living and receiving treatment on a CAMHS inpatient unit and their wider environment. Specific subthemes related to environmental restrictions of the unit, included opportunities available to engage in activities in a restricted environment defined as lack of access to outdoor spaces the food provision and the changing dynamics of the environment and pressures on staff.

Opportunities in a restricted environment

A range of facilities were available including a sports hall, exercise equipment, and a communal kitchen. However, access was limited, for example, “ sport stuff was locked because it was reserved for college” . Some individuals could not leave the unit and would be reliant on ward-based activities, which required staff availability. However, staff claimed “the main problem is trying to get people engaged” particularly for those who did not have leave. Therefore, young people stressed the importance of making sure there is an “activity for everyone” on and off the wards. However, staff claimed they would get bored easily, particularly if they did not have anything to aim towards, or were given repetitive tasks.

ST3"it was quite hard maintaining the motivation to try and get people doing it regularly”.

A discrepancy occurred between the views of staff and young people. Staff claimed activities were “always off the cuff, informal and really does benefit” because “ they’ve got options, but they get bored of them really quick” , compared with structured activities where attendance at groups was not guaranteed. However, this contrasted somewhat with the views of young people who although did have a desire for a “ variety” of activities, they wanted consistent and organized activities. However, activities were viewed as inconsistent and sometimes cancelled at short notice meaning young people thought “ why bother it’s going to get cancelled” , thus reducing their willingness to engage.

YP7:“The walking group it doesn’t happen often as I would like it to and the netball group has stopped as well so there’s nothing much"… “in here generally there isn’t much to do… So what people would do is stay here and eat.”

Physical restrictions and limited space in a smaller, confined environment resulted in individuals being more inactive, and therefore, day-to-day activity was limited.

ST6:“if you haven’t got leave then you’re not even walking anywhere. Your college is at the bottom of the corridor and the dining room is at the door, so it is quite difficult for them. They have got the sports hall, but college do lock quite a lot of it away.”

The ward environment was also described as unpredictable, with frequent admissions and discharges, and a changing presence of young people/staff. Planning activity sessions was difficult, despite attempting to fit within the usual ward schedule, they were often inconsistent, and attendance varied. Young people claimed incidents occurred frequently, which had a detrimental effect on their ability to engage in activities for example, “ if there’s an incident and you’re meant to go out then you can’t go out”.

Food availability

Food came from the hospital catering department, as well as items bought on leave or brought in by visitors. A negative view was taken of the food available with frequent descriptions of food being:

beige”, “bland”, “stodgy”, “carby”, “unhealthy”, “pre-packaged crap”, “reheated.

Healthier options were provided, yet were described as unappealing (e.g., “ limp salads ”). Young people claimed “ the choice of food would stop someone eating a healthy diet” and that “ half of us don’t like the look of it so won’t eat it”. They wanted fresh and healthy home-cooked food, and the opportunity to prepare meals themselves. Staff claimed that “ There is the option for us to let young people choose their meals, it’s just very difficult when the ward is so busy” and therefore it was not always feasible to achieve this as young people may be unavailable when the order needed to be made or staff were under clinical pressure. Staff liaised with catering to make specific requests; however, time did not always permit this approach, and many described ordering “ quick ” and “ safe options ”, acknowledging that it was not the healthiest, but what they knew would get eaten, e.g., pizza, chips, burgers, pastas. Snack foods such as biscuits/toast were also readily available, and although fruit was provided staff claimed young people avoided it.

Although kitchen facilities were available, staff claimed it was not always easy to use due to time/funding restrictions, and practical barriers such as “ missing equipment ”. Staff also claimed it required “ a lot of hoops to jump through ”. This is despite them reporting high levels of enjoyment and engagement in cooking activities, and young people wanting “ fresh home-cooked food ” options. Additionally, for those who were able to leave the opportunities to purchase food were limited due to the hospital location being “ surrounded by fast-food places” and a local supermarket.

ST2:“nearby things are like Tesco and they will go and buy like chocolates, crisps whatever just cause it’s convenient. YP1:“it’s really hard, doing it here you can’t just go to the gym, … like at home you have like loads of different foods in and you can make your own food here it get brought up”.

Influence of others

The third theme was the influence other people had on young people’s physical health and how this could be both positive and negative and included subthemes of staff members, peers, and family. Receiving encouragement, guidance and advice was a supporting factor for physical health. For example, being guided to make better food choices, encouraging physical activities or helping them attend group exercise sessions by alleviating worries or concerns.

“ YP3:“being encouraged would help, maybe by other young people as well, bit of reassurance” ”.

Staff attitudes had a significant effect. When staff displayed an interest and passion for physical health, exercise, or nutrition, this had a positive impact on young people and the ward environment.

ST5:“one of the new support workers is a yoga teacher and they really like getting involved in that”.

Working collaboratively, such as staff and service users exercising together was seen to “break down barriers” , as they would “ all look like each other” . Examples included netball tournaments for staff and young people, group cooking or smoothie sessions, and walking/running groups.

Staff beliefs about their job role had an impact, some claiming physical health was not their responsibility or their role. They also described feeling a lack of control over young people and their actions; a dynamic which was further compounded by young people being treated as adults, with staff wanting to avoid too many restrictions, but equally being limited by trying to adopt a caregiver role in the absence of a parental figure.

ST2:“I guess it’s just difficult because we are not parents, we can’t sort of shout at them and be like that’s bad for you cause they are not going to… that’s like as much as we can do!”

One example discussed by many of the staff related to the ordering of takeaways, and the lack of control staff felt like they had, some referring to young people as ‘adults’, despite being under 18.

ST4:“Yeah it is difficult, at one point we did try to monitor it and we did initially say takeaways were limited to once a week or on a Saturday you know. But it was very, very, difficult to maintain that because of restrictive practice and you know they are adults, and the capacity, lots of the loopholes prevented us really from actually being able to stop that.

When staff were available and could provide support and encouragement this was seen as particularly valuable, for example “the staff push me, and I always feel a lot better afterwards ”. Staff claimed they tried to encourage young people by being responsive to their needs and problem-solving barriers.

ST4:“if they’ve got the swimming group… goes down really well here, they do enjoy it. Some of them are reluctant due to body image, which can cause a problem sometimes, in which case we just support with buying more suitable swimwear.”.

However, ongoing clinical pressures meant they were not always able to do their job to the best of their ability and got pulled into different duties. This meant that activities such as exercise groups were cancelled, suggesting that physical activities were not a clinical priority.

Peers had a profound impact on the behaviors of young people. They valued encouragement and validation from others, wanting to fit in, to not be seen as “ weird ” or “ outcast” if they behaved differently to their friends and worrying about being judged. They were conscious of how they were perceived by others and being accepted by their peers through ‘doing what everyone else is doing’ . This was echoed by staff who claimed they were doing what ‘normal teenagers do’ , particularly in the context of following trends and being influenced by peers.

ST6:“I don’t know when you’re a teenager and stuff it’s important what your mates are doing.“ YP3:“I think I have quite low self-esteem so sometimes that stops me from wanting to go and play netball, because I’m little bit scared of being judged… I think being encouraged would help, maybe by other young people as well, bit of reassurance.

Group dynamics significantly affected participation in groups. Staff described “ difficult dynamics” and “ if one person… has a lot of influence on the ward, if they won’t take part a lot of the other young people won’t take part”. Similarly, if someone stopped attending a group it would have a detrimental impact on engagement, highlighting how impressionable peers were.

ST3:“I think we do find especially with the activities; you need a strong influence to participate, you know with that one young person who will get on board and then 4 or 5 of the others might come too.

The risk of not being accepted in a peer group played a role in what young people saw as important activities, sometimes preferring to stay in communal areas to socialize, rather than engaging in health activities.

YP2:“maybe other people might not want to do it so that they can spend time with other people…. they might not want to go out to do exercise because they want to stay on the ward to be friendly”.

Parents/Guardians

The influence of parents/guardians was discussed, particularly in relation to bringing in food. Staff stated parents often brought in “really unhealthy food” or treats in an act of “over caregiving a child who is in hospital” to “ elicit care and affection”. Examples of these included “share-size chocolate bars”, “fast-food”, “multipacks of crisps”, “sweets ”. Some young people described at home their parents would provide them with healthier home-cooked foods, compared to when they are eating with their peers, for example, “… me and my friends get pizza and like McDonalds, and then my mum makes like vegetables and just like you know home-cooked stuff” . They suggested the food was different at home when cooked by their parents to what they have access to in hospital, or when with peers which was not as fresh/home cooked. However, it could also be an improvement for people who had a difficult home environment, as it meant they had access to regular hot food.

The aim of this study was to conduct a qualitative exploration of the physical health of young people on CAMHS inpatient units, specifically identifying what factors affect it and what support would be helpful. Young people on mental health inpatient units experience multiple complex factors which contribute to the onset of poor physical health. The main themes were individual factors (such as their attitudes, knowledge, beliefs, mental health), influence of others (peers, staff, family), and the complexities of the inpatient environment. Young people and staff suggested ways to optimise the inpatient environment and identified approaches which may benefit their physical health.

The factors influencing physical health were complex with young people central to all internal and external influences (see Fig.  1 for an overview of theme names and subthemes). This fits within an ecological systems theory, which explains how an individual’s development and behaviour is shaped, given the influence of other people, the environment, policy, and societal systems [ 29 ]. This can map on to our findings and themes of individual factors (such as mental health, attitudes and beliefs and knowledge), the CAMHS inpatient environment and the influence of other people namely peers, care teams and families. Considering how these factors combine can help understand and explain the main underlying issue, which is the reason why young people on CAMHS inpatient units are at increased risk for physical co-morbidities. For example, if the environment is restrictive, chaotic, and inconsistent, people exert negative influence through peer pressure/lack of encouragement and if the young person has low motivation, poor mental health will only exacerbate the risk of developing physical health conditions. Conversely, looking at how these factors interact in a positive and conducive way can result in important recommendations to optimise clinical practice and care for young people (See Fig.  2 for an example of how these factors may combine to result in a positive or negative outcome).

figure 2

Combination of factors and impact on physical health

Clinical implications

This study has important clinical implications. It adds to ongoing research which suggests that young people on inpatient units face a myriad of challenges to living a healthy lifestyle [ 9 , 15 , 18 , 30 ]. Given the high rates of premature mortality and preventable ill-health experienced by people with SMI, it is imperative that we address this inequality for young people. Our study adds further concern regarding the ‘obesogenic’ nature of inpatient environments [ 12 , 13 ]. Yet, it is important to note many barriers are modifiable, and can be improved through changes to policy, practice, and optimisation of health care provision. Admission to an inpatient unit is a distressing time for individuals, yet it is also a key opportunity to intervene to change lifetime behaviours. The structured nature of the environment can be used to an advantage whereby care providers have the control to equip young people with life skills and knowledge. According to the WHO, physical health behaviours adopted during adolescence (such as poor diet, smoking, inactivity), are likely to persist into adulthood [ 31 ]. For example, during adolescence sedentary behaviour often replaces light activity, and increases the risk of depression later in life [ 32 ].Therefore, it is essential that physical health is considered in inpatient units to avoid iatrogenic harm, for example, by increasing physical activity levels.

There are many factors relating to staff which carry important clinical implications. There were several instances where the views of young people contrasted to staff, (such as structured approach compared to ad-hoc), and where staff views conflicted, claiming they wanted to treat young people as adults but feeling like they had no control over their behaviours. This can be explained using the principles of attachment theory which argues the importance of secure attachments during adolescence particularly in a post pandemic world [ 33 ], as well as previous research of mental health recovery in young people [ 34 ]. Additionally, in line with research in other clinical populations [ 22 , 35 , 36 , 37 ], some staff did not view physical health as part of their job role/responsibility in a mental health setting. This suggests a further training/education is needed for mental health professionals targeting confidence and attitudes towards physical health. An example of where this has been successful is the ‘Keeping our Staff in Mind’ study where a brief lifestyle intervention for staff had a positive impact on physical health outcomes in both staff and young people [ 38 , 39 ]. Additionally, staff have a duty of care as the main caregiver in the absence of a parental figure to support individuals with mental and physical health. Our findings suggest that young people value the encouragement and support from staff, despite wanting to become autonomous. Future work should build on this to improve the ward culture through equipping staff with skills and modelling positive behaviours for young people through shared dining and getting involved in physical activities, whilst also engaging in collaborative planning through discussions on the ward.

Clinical recommendations

Table  3 contains several examples of clinical recommendations to optimise service provision and care for young people, using some specific examples from the themes and subthemes which we found in our study.

Strengths and limitations

To the best of our knowledge this is the first study to consider opinions of both young people and staff on CAMHS inpatient units. Qualitative analysis gives a deep and rich account of the data. This provides us with important clinical information and has real world implications, adding to the growing movement to improve physical health of people with SMI. However, our study sample was not representative of the area the trust serves, or the range of occupations at the trust. For example, we did not manage to recruit any male service users, however, at the time service users were mainly female. Additionally, interviews were conducted in one hospital, which means operational barriers may differ nationally and internationally. Some of the interviews were conducted by a CAMHS consultant psychiatrist which has the potential to affect responses and introduce a power imbalance. However, the psychiatrist involved in the study was not directly involved in clinical care and decision making for these service users. Additionally, in an attempt to mitigate any other risk of bias, all participants were notified in advance and informed that they could request to be interviewed by another member of the research team. Furthermore, this study took place prior to the covid pandemic, which has resulted in changes to clinical care delivery [ 40 , 41 ]. However, the growing evidence base suggests our findings may have utility to other health providers.

Future research

There is an imperative need to address the barriers that young people experience to living a healthy lifestyle on inpatient units. There is an increasingly strong evidence base arising to show the benefits of using physical health interventions to improve outcomes for young people [ 9 , 14 , 18 ]. Future work should explore the development and implementation of initiatives considering the views of young people, clinicians, caregivers, and commissioners. This may include changes to clinical practice and procedures to remove operational barriers, and development of training/education programmes. Further attention should be given to address the conflicting views of young people and staff, by sharing research findings and encourage collaborative working. Any future work should adopt a developmental approach, due to the overarching influence of adolescence discussed in the interviews (such as the high value placed on peer influence and social desirability). This is a well-known critical factor included in public health programmes for young people for example, in areas such as sexual health, substance use, drink/drug driving awareness, knife crime and anti-bullying [ 42 ]. Therefore, there is a need to identify how to balance factors related to adolescent development such as increasing autonomy, independence, and choice, whilst allowing and encouraging staff to guide and shape the choices young people are making, acting as therapeutic caregivers in the absence of parents/guardians.

There is an urgent need to develop interventions to reduce the risk of young people developing preventable illness and disease and improve long-term physical health outcomes. Young people’s physical health is affected by multiple factors, and fall into three main themes individual factors, the environment and influence of others. Clinical teams cannot care for mental health without considering physical health as the two are intrinsically intertwined, therefore it is vital that the barriers identified in this study are addressed, and suggestions for clinical improvements are explored. More work is needed, including collaborative research with young people and clinical teams, improvements to clinical care provision and optimisation of the inpatient environment. This will ensure all young people with SMI will have the opportunity to live an active, healthy, and fulfilled life, and ultimately reduce the inequality gap in physical health care provision.

Data availability

The datasets analysed during the current study are available from the corresponding author should a reasonable request be made.

Abbreviations

Child and Adolescent Mental Health Services

Children and Young People

Greater Manchester Mental Health NHS Foundation Trust

National Health Service

National Institute for Health and Care Excellence; SMI: Serious Mental Illness

World Health Organisation

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Acknowledgements

We acknowledge the contributions of all service users and staff members who took part. We are grateful to the clinical teams who allowed this research to take place by assisting with recruitment and allowing staff members time to meet with the research team. We acknowledge all former team members who assisted during the data collection and early analysis phase.

The funding for this research came from internal NHS Research Capability Funding at Greater Manchester Mental Health NHS Foundation Trust.

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Rebekah Carney, Heather Law, Parise Carmichael-Murphy, Leah Charlton & Sophie Parker

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Rebekah Carney, Parise Carmichael-Murphy, Leah Charlton & Sophie Parker

Greater Manchester Mental Health NHS Foundation Trust, Bury New Road, Prestwich, M13 3BL, UK

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Contributions

Interviews were conducted by RC and SI. Data analysis and interpretation was conducted by RC, HL, SI, SP. RC drafted the first version of the manuscript. LC PCM RC developed the initial concept for the diagrams and RC created the first draft which was reviewed by all authors and the final versions approved. All authors contributed to and approved the final manuscript.

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Correspondence to Rebekah Carney .

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This study was approved by North-West and Greater Manchester East Ethics Committee (ref:19/NW/0458; August 2019). All participants provided written informed consent prior to taking part in the study and parental or caregiver consent/assent for young people under the age of 16.

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Carney, R., Imran, S., Law, H. et al. “If you’re struggling, you don’t really care” – what affects the physical health of young people on child and adolescent mental health inpatient units? A qualitative study with service users and staff. BMC Psychiatry 24 , 498 (2024). https://doi.org/10.1186/s12888-024-05858-1

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Received : 09 August 2023

Accepted : 21 May 2024

Published : 09 July 2024

DOI : https://doi.org/10.1186/s12888-024-05858-1

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  • Physical health
  • Qualitative
  • Mental health

BMC Psychiatry

ISSN: 1471-244X

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