Award Title: The clinical and cost-effectiveness of exercise intervention for depression in adolescents: a phased multi-site randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Depression in adolescents is a serious problem that can lead to poor mental health and stigma throughout a person’s life. Depression is reported in around 20% of young people by the time they are 18 years of age. Over half continue to be depressed into adulthood, with many attempting suicide. Problems include difficulties at home and school, maintaining friendships and taking part in social activities, including exercise. Young people with depression often delay seeking psychological support. Antidepressants can help some, but they have negative side effects. Research shows that adults with depression benefit from exercise, but it is not known whether exercise is helpful for young people who are depressed. _x000D_
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The aim of this research is to find out whether exercise is an effective treatment for young people with depression and whether it is good value for money for the NHS. We will recruit young people, aged 13-17 years, diagnosed with depression, from Child & Adolescent Mental Health Services and GP practices. The young people will continue to receive their usual health care. Those suitable for exercise will be allocated randomly (e.g. throwing a dice) to one of 3 groups:_x000D_
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1. High intensity exercise, through vigorous activities (basketball, football, dance, boxing) _x000D_
2. Low intensity exercise, through moderate activities (table tennis, yoga, bowling, gymnastics) _x000D_
3. An active control of social non-exercise based activities (playing games, watching films)_x000D_
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Participants in groups 1 & 2 will be offered 2 x 60-minute exercise sessions per week for 12 weeks. All groups will also receive education and support on healthy living.  Exercise sessions will be delivered by Registered Exercise Professionals (REPs) supported by Peer Support Workers (PSWs) at local sports and community centres. The research team will collect information from participants at the start, and at 14, 26, and 52 weeks. This will include questionnaires on depression, quality of life, self-esteem, service use, session attendance and changes in physical activity. We will ask some participants, parents/carers, REPs and PSWs about their experience of the exercise sessions and participation. _x000D_
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The research will be conducted in 2 phases over 5 years:_x000D_
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1. In the first 18 months we will explore how best to undertake this research (feasibility trial). We will recruit 60 young people (20 per group) from 3 sites to test the recruitment of young people, attendance and exercise achieved and completion of questionnaires.  This will help us improve the study design and feasibility.  _x000D_
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2. We will then conduct the main study over the next 42 months in 8 locations.  In the first 8 months a pilot study with 150 young people will be complete to check that the study procedures are working as expected.  Over the next 34 months 1044 young people will be recruited and the data analysed to complete the study at month 60._x000D_
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We have talked to young people, some with depression, and a Public Involvement Research group at the University of Hertfordshire (UH) about this research; their advice has shaped the study. We will continue to involve them and various stakeholders including parents/carers, health professionals and policy makers in the research.  They will also help us to share our findings at the end of the study.  The project will be led by UH in collaboration with the Universities of Bedfordshire and East Anglia, various NHS Mental Health Trusts and County Sports Partnerships.

Lay Abstract: Existing research demonstrates that depression among young people is highly prevalent and increasing(1–3).  Recent research suggests that adolescents who seek help do benefit from contact with mental health services(4,5).  Depression among young people presents a significant burden to Health Care Services, the young person and their family, and future potential cost where untreated over the longer term. Provision of care for young people with mental health problems is a current Department of Health priority(6-8)._x000D_
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Exercise provides a treatment option for health care services, that avoids problems associated with pharmacological interventions, and does not rely on hard pressed services providing psychological therapy(9,10). There is a growing body of evidence that exercise is potentially an effective treatment intervention for depression in young people, but there remains considerable uncertainty, with poor quality, small scale trials, and little evidence addressing the intensity of exercise required(11-15)._x000D_
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The current proposal is for a multi-site, single blinded, superiority, cluster randomised effectiveness RCT with nested process and economic evaluations. The study is designed to address whether:_x000D_
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- Physical exercise of a high, or a low intensity compared with an active control improves depression symptoms in young people,_x000D_
- The cost-effectiveness of an exercise interventions delivered in a community setting, and_x000D_
- The extent to which adherence to exercise differs between high and low intensity exercise._x000D_
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The study will compare 3 interventions consisting of a high intensity exercise intervention, compared to a low intensity intervention, and an active control group.  All intervention groups will include an education component (Healthy Living) with behaviour change techniques facilitating exercise adherence and maintenance over the longer term. The study includes a feasibility randomised trial, and an effectiveness trial including an internal pilot study with appropriate stop-go criteria(16–18)._x000D_
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The feasibility randomised trial (N=60) will be undertaken in the first 18 months to evaluate the feasibility of delivering the main trial as planned.  Information gained from this study will inform protocol development and demonstrate the ability to recruit sufficient patients into a larger scale trial (with planned stop, revise, go criteria)._x000D_
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The main trial (N=1044), with internal pilot study (N=150), will provide definitive evidence of the clinical and cost effectiveness of the intervention for the treatment of depression in young people aged 13 to 17._x000D_
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The interventions will be delivered through the national network of County Sports Partnerships in local community settings.  Young people seeking support for depression will be referred from GP Practices, and Child and Adolescent Mental Health Services.  The interventions will be delivered by Registered Exercise Professionals supported by Peer Support Workers. Young people are followed up at 14, 26 and 52 weeks. This will include questionnaires on depression, quality of life, self-esteem, and service use. Some young people and intervention staff will be interviewed to understand their experience of the exercise sessions and participation._x000D_
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Young people (PPI) have influenced the design of the study, and along with parents and other stakeholders, will continue to provide significant input throughout the study, and provide support for dissemination.

Research Activity Codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health Categories: MENTAL HEALTH