TY - JOUR
T1 - 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
AU - Berry, Clio
AU - Hodgekins, Joanne
AU - French, Paul
AU - Clarke, Tim
AU - Shepstone, Lee
AU - Barton, Garry
AU - Banerjee, Robin
AU - Byrne, Rory
AU - Fraser, Rick
AU - Grant, Kelly
AU - Greenwood, Kathryn
AU - Notley, Caitlin
AU - Parker, Sophie
AU - Wilson, Jon
AU - Yung, Alison R.
AU - Fowler, David
N1 - 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.
PY - 2022/3
Y1 - 2022/3
N2 - 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.
AB - 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.
KW - anxiety disorders
KW - cognitive-behavioural therapies
KW - depressive disorders
KW - psychosocial interventions
KW - Social functioning
UR - http://www.scopus.com/inward/record.url?scp=85124022857&partnerID=8YFLogxK
U2 - 10.1192/bjp.2021.206
DO - 10.1192/bjp.2021.206
M3 - Article
SN - 0007-1250
VL - 220
SP - 154
EP - 162
JO - The British Journal of Psychiatry
JF - The British Journal of Psychiatry
IS - 3
ER -