A randomised controlled trial of energetic activity for depression in young people (READY): a multi-site feasibility trial protocol
Authors
Howlett, NeilBottoms, Lindsay
Chater, Angel M.
Clark, A.B.
Clarke, T.
David, L.
Irvine, K.
Jones, A.
Jones, J.
Mengoni, S.E.
Murdoch, J.
Pond, M.
Sharma, S.
Sims, E.J.
Turner, D.A.
Wellsted, D.
Wilson, J.
Wyatt, S.
Trivedi, Daksha
Affiliation
University of HertfordshireUniversity of Bedfordshire
University of East Anglia
Norfolk and Suffolk NHS Foundation Trust
Issue Date
2021-01-04Subjects
depressionfeasibility trial
exercise
behaviour change
low mood
physical activity
Subject Categories::C600 Sports Science
Metadata
Show full item recordAbstract
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.Citation
Howlett N, Bottoms L, Chater A, Clark AB, Clarke T, David L, Irvine K, Jones A, Jones J, Mengoni SE, Murdoch J, Pond M, Sharma S, Sims EJ, Turner DA, Wellsted D, Wilson J, Wyatt S, Trivedi D (2021) 'A randomised controlled trial of energetic activity for depression in young people (READY): a multi-site feasibility trial protocol', Pilot and Feasibility Studies, 7 (1), pp.-.Publisher
BioMed Central LtdJournal
Pilot and Feasibility StudiesPubMed ID
33390189PubMed Central ID
PMC7779325/Additional Links
https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00734-7https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779325/
Type
ArticleLanguage
enISSN
2055-5784EISSN
2055-5784ae974a485f413a2113503eed53cd6c53
10.1186/s40814-020-00734-7
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