TY - JOUR
T1 - Open Dialogue compared to treatment as usual for adults experiencing a mental health crisis: Protocol for the ODDESSI multi-site cluster randomised controlled trial
AU - Pilling, Stephen
AU - Clarke, Katherine
AU - Parker, Georgie
AU - James, Kirsty
AU - Landau, Sabine
AU - Weaver, Timothy
AU - Razzaque, Russell
AU - Craig, Tom
N1 - Funding Information:
Funding for this research programme is provided by the National Institute for Health Research (NIHR) PGfAR Project Number: RP-PG-0615-2002 . SL and KJ's contributions represent independent research part funded by the NIHR Biomedical Research Centre (South London and Maudsley NHS Foundation Trust and King's College London ) and the NIHR Applied Research Collaboration South London ( King's College Hospital NHS Foundation Trust ). SP is also supported by the UCLH Biomedical Research Centre .
Publisher Copyright:
© 2021 The Authors
PY - 2022/2
Y1 - 2022/2
N2 - Background ‘Open Dialogue’ is a social network model of crisis and continuing mental healthcare which involves elements of service delivery such as immediate response and a style of therapeutic meeting called network meetings. Although there are indications from non-randomised studies that it may help people in their recovery from severe mental health crises and improve long-term outcomes, this has yet to be tested in a randomised controlled trial. Methods This paper outlines the protocol for a multi-site cluster-randomised control trial assessing the clinical and cost-effectiveness of Open Dialogue compared to treatment as usual (TAU) for individuals presenting in crisis to six mental health services in England. The primary outcome is time to relapse, with secondary outcomes including measures of recovery and service use. Participants will be followed-up for two years, with data collected from electronic medical records and researcher-led interviews. The analysis will compare outcomes between treatment groups as well as investigating potential mediators of effect: shared decision-making and social network quality and size. Carers of a subsample of participants will be asked about their experiences of shared decision-making, carer burden, and satisfaction. Discussion This trial will provide evidence of whether Open Dialogue services implemented in the English mental health system is an effective alternative to current care and may have important implications for the organization of community mental health services. Trial registration: retrospectively registered (108 participants recruited of 570 target) on 20/12/2019, ISRCTN52653325.
AB - Background ‘Open Dialogue’ is a social network model of crisis and continuing mental healthcare which involves elements of service delivery such as immediate response and a style of therapeutic meeting called network meetings. Although there are indications from non-randomised studies that it may help people in their recovery from severe mental health crises and improve long-term outcomes, this has yet to be tested in a randomised controlled trial. Methods This paper outlines the protocol for a multi-site cluster-randomised control trial assessing the clinical and cost-effectiveness of Open Dialogue compared to treatment as usual (TAU) for individuals presenting in crisis to six mental health services in England. The primary outcome is time to relapse, with secondary outcomes including measures of recovery and service use. Participants will be followed-up for two years, with data collected from electronic medical records and researcher-led interviews. The analysis will compare outcomes between treatment groups as well as investigating potential mediators of effect: shared decision-making and social network quality and size. Carers of a subsample of participants will be asked about their experiences of shared decision-making, carer burden, and satisfaction. Discussion This trial will provide evidence of whether Open Dialogue services implemented in the English mental health system is an effective alternative to current care and may have important implications for the organization of community mental health services. Trial registration: retrospectively registered (108 participants recruited of 570 target) on 20/12/2019, ISRCTN52653325.
UR - http://www.scopus.com/inward/record.url?scp=85122314687&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.cct.2021.106664
DO - https://doi.org/10.1016/j.cct.2021.106664
M3 - Article
SN - 1551-7144
VL - 113
JO - CONTEMPORARY CLINICAL TRIALS
JF - CONTEMPORARY CLINICAL TRIALS
M1 - 106664
ER -
