Energetic activity for depression in young people aged 13-17 years: the READY feasibility RCT

Smith, Megan, James, Ryan, Howlett, Neil, Mengoni, Silvana E, Jones, Julia, Sims, Erika ORCID: https://orcid.org/0000-0002-7898-0331, Turner, David ORCID: https://orcid.org/0000-0002-1689-4147, Grant, Kelly, Clark, Allan ORCID: https://orcid.org/0000-0003-2965-8941, Murdoch, Jamie, Bottoms, Lindsay, Wilson, Jonathan, Sharma, Silvani, Chater, Angel, Guillard, Cecile, Clarke, Timothy, Jones, Andrew, David, Lee, Wyatt, Solange, Rourke, Claire, Wellsted, David and Trivedi, Daksha (2024) Energetic activity for depression in young people aged 13-17 years: the READY feasibility RCT. NIHR Journals Library. (In Press)

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Abstract

Background: Prevalence of depression is increasing in young people (YP). Behaviour change interventions providing benefits equal to or greater than talking therapies or pharmacological alternatives are needed. Exercise could be beneficial for YP with depression, but we lack robust, trials of effectiveness.   Objective(s): Test whether an exercise intervention targeting YP with depression is feasible, including recruitment and retention of YP, recruitment and training of exercise professionals and intervention delivery.   Design: Three-arm cluster feasibility Randomised Controlled Trial (RCT) with embedded process evaluation and health economic data collection.   Setting: Local community venues in Hertfordshire, Bedfordshire, and Norfolk.   Participants: Young people aged 13-17 years experiencing mild to moderate low mood or depression (indicated by scoring 17-36 on the Child Depression Inventory version 2 (CDI 2)) identified by mental health services, schools or by self-referral. Interventions: Participants were randomised to one of three groups: high intensity exercise, low intensity exercise, or a social activity control. Group sessions ran twice weekly for 12 weeks delivered by registered exercise professionals (REP), supported by mental health support workers (MHSW).   Main outcome measures: Referral, recruitment, and retention rates; attendance at group sessions; adherence to and ability to reach intensity during exercise sessions, proportions of missing data, and adverse events measured at baseline, 3, and 6 months; resource use; reach and representativeness.   Results: Of 321 referrals to the study, 173 were assessed for eligibility and of the target sample size of 81, 15 were recruited and 14 randomised (1 withdrawal). Retention rate was 71.4% and attendance at intervention sessions was >67%; data completeness was >80% for baseline assessments. Follow up completion rate at 14 weeks was >80% for most outcomes, with 50% for accelerometer data in the low intensity group. Trial processes and the intervention were acceptable to YP. Barriers and facilitators to intervention delivery were identified.   Limitations: Findings highlighted challenges around recruitment, delivery of exercise interventions and informed ways of addressing barriers to recruitment for future studies. The study was conducted between October 2020 and August 2022 and consequently COVID-19 had a disruptive impact on implementation.   Conclusions: A large, randomised trial of the effectiveness of the intervention is not feasible using the current study design, but issues relating to recruitment could be addressed with further work. Future work: Developing appropriate recruitment strategies via triage services, GP practices, schools and social media and early engagement with local CRN (Clinical Research Network) to support the recruitment into the study would address significant shortfalls identified. YP who are deemed unsuitable for mental health services should be followed up to offer participation in such interventions. Collaborations between the NHS services and sports delivery partners should consider in-person contact with YP rather than remote consultations. Recruiting through GP practices is effective and relatively inexpensive. The role of community engagement (social-media, public health agencies, community groups) needs to be further explored. Strong PPI (Public and Patient Involvement) and engagement via YP Advisory Groups is important to ensure that research is relevant to YP.   Study Registration: ISRCTN, ISRCTN66452702. Registered 9 April 2020, http://www.isrctn.com/ISRCTN66452702 Funding details: This project was funded by the Health Technology Assessment (Reference Number: 17/78/10) The views expressed are those of the author(s) and not necessarily of the NIHR or the Department of Health and Social Care.

Item Type:	Article
Additional Information:	Funding information: This project was funded by the Health Technology Assessment (Reference Number: 17/78/10) The views expressed are those of the author(s) and not necessarily of the NIHR or the Department of Health and Social Care.
Uncontrolled Keywords:	sdg 3 - good health and well-being ,/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being
Faculty \ School:	Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups:	Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit Faculty of Medicine and Health Sciences > Research Centres > Population Health Faculty of Medicine and Health Sciences > Research Groups > Health Economics Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care Faculty of Medicine and Health Sciences > Research Groups > Epidemiology and Public Health
Depositing User:	LivePure Connector
Date Deposited:	28 Aug 2024 13:30
Last Modified:	28 Aug 2024 13:30
URI:	https://ueaeprints.uea.ac.uk/id/eprint/96377
DOI:

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