University of Hertfordshire

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Original languageEnglish
Article number6
Pages (from-to)6
JournalBMC Pilot and Feasibility Studies
Volume7
Issue1
DOIs
Publication statusPublished - 4 Jan 2021

Abstract

BACKGROUND: Prevalence of depression is increasing in young people, and there is a need to develop and evaluate behavioural interventions which may provide benefits equal to or greater than talking therapies or pharmacological alternatives. Exercise could be beneficial for young people living with depression, but robust, large-scale trials of effectiveness and the impact of exercise intensity are lacking. This study aims to test whether a randomised controlled trial (RCT) of an intervention targeting young people living with depression is feasible by determining whether it is possible to recruit and retain young people, develop and deliver the intervention as planned, and evaluate training and delivery.

METHODS: The design is a three-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be help-seeking young people, aged 13-17 years experiencing mild to moderate low mood or depression, referred from three counties in England. The intervention will be delivered by registered exercise professionals, supported by mental health support workers, twice a week for 12 weeks. The three arms will be high-intensity exercise, low-intensity exercise, and a social activity control. All arms will receive a 'healthy living' behaviour change session prior to each exercise session and the two exercise groups are energy matched. The outcomes are referral, recruitment, and retention rates; attendance at exercise sessions; adherence to and ability to reach intensity during exercise sessions; proportions of missing data; adverse events, all measured at baseline, 3, and 6 months; resource use; and reach and representativeness.

DISCUSSION: UK National Health Service (NHS) policy is to provide young people with advice about using exercise to help depression but there is no evidence-based exercise intervention to either complement or as an alternative to medication or talking therapies. UK National Institute for Health and Care Excellence (NICE) guidelines suggest that exercise can be an effective treatment, but the evidence base is relatively weak. This feasibility trial will provide evidence about whether it is feasible to recruit and retain young people to a full RCT to assess the effectiveness and cost-effectiveness of an exercise intervention for depression.

TRIAL REGISTRATION: ISRCTN, ISRCTN66452702 . Registered 9 April 2020.

Notes

Funding Information: We would like to acknowledge the role of Maria Leathersich, Cecile Guillard, and Antony Colles in the design, set-up, and management of the READY trial database. We would also like to thank the PPI and young people?s groups who have provided valuable advice and support that has shaped the design of this study, including the following: the Public Involvement in Research group (PIRg) at the University of Hertfordshire; the Youth Council of Hertfordshire Partnership University NHS Foundation Trust; Young people?s groups from Active Luton and YC Hertfordshire. Funding Information: This trial is being funded by the Health Technology Assessment funding stream of the NIHR (Reference Number: 17/78/10). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Publisher Copyright: © 2021, The Author(s).

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