Clinical and cost-effectiveness of social recovery therapy for the prevention and treatment of long-term social disability among young people with emerging severe mental illness (PRODIGY): Randomised controlled trial

Berry, Clio, Hodgekins, Joanne, French, Paul, Clarke, Tim, Shepstone, Lee, Barton, Garry, Banerjee, Robin, Byrne, Rory, Fraser, Rick, Grant, Kelly, Greenwood, Kathryn, Notley, Caitlin, Parker, Sophie, Wilson, Jon, Yung, Alison R. and Fowler, David (2022) Clinical and cost-effectiveness of social recovery therapy for the prevention and treatment of long-term social disability among young people with emerging severe mental illness (PRODIGY): Randomised controlled trial. The British Journal of Psychiatry, 220 (3). pp. 154-162. ISSN 0007-1250

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Abstract

Background Young people with social disability and severe and complex mental health problems have poor outcomes, frequently struggling with treatment access and engagement. Outcomes may be improved by enhancing care and providing targeted psychological or psychosocial intervention. Aims We aimed to test the hypothesis that adding social recovery therapy (SRT) to enhanced standard care (ESC) would improve social recovery compared with ESC alone. Method A pragmatic, assessor-masked, randomised controlled trial (PRODIGY: ISRCTN47998710) was conducted in three UK centres. Participants (n = 270) were aged 16-25 years, with persistent social disability, defined as under 30 hours of structured activity per week, social impairment for at least 6 months and severe and complex mental health problems. Participants were randomised to ESC alone or SRT plus ESC. SRT was an individual psychosocial therapy delivered over 9 months. The primary outcome was time spent in structured activity 15 months post-randomisation. Results We randomised 132 participants to SRT plus ESC and 138 to ESC alone. Mean weekly hours in structured activity at 15 months increased by 11.1 h for SRT plus ESC (mean 22.4, s.d. = 21.4) and 16.6 h for ESC alone (mean 27.7, s.d. = 26.5). There was no significant difference between arms; treatment effect was -4.44 (95% CI -10.19 to 1.31, P = 0.13). Missingness was consistently greater in the ESC alone arm. Conclusions We found no evidence for the superiority of SRT as an adjunct to ESC. Participants in both arms made large, clinically significant improvements on all outcomes. When providing comprehensive evidence-based standard care, there are no additional gains by providing specialised SRT. Optimising standard care to ensure targeted delivery of existing interventions may further improve outcomes.

Item Type: Article
Additional Information: Author Acknowledgements: We are very grateful to the young people who participated in the trial and all family members, friends, referring services, clinicians and other people who supported their involvement. We thank the PRODIGY Advisory Team, Trial Steering Committee, and Data Monitoring and Ethics Committee members for their invaluable involvement and guidance throughout this trial. We wish to acknowledge the support of our National Institute for Health Research programme manager. We thank all staff in the sponsoring and hosting organisations for supporting the project. We are grateful to Norwich Clinical Trials Unit for their support with data management, statistical and health economic analysis. Finally, we thank all the PRODIGY therapists and research assistants for their enthusiasm and dedication to supporting participants in their involvement with PRODIGY.
Uncontrolled Keywords: anxiety disorders,cognitive-behavioural therapies,depressive disorders,psychosocial interventions,social functioning,psychiatry and mental health,sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2738
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 07 Jan 2022 09:30
Last Modified: 24 May 2022 14:46
URI: https://ueaeprints.uea.ac.uk/id/eprint/82920
DOI: 10.1192/bjp.2021.206

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