Abstract

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.MethodsThis 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.DiscussionThis 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.

Highlights

  • Mental health conditions often involve notable changes in behav­ iour, thinking and emotion associated with distress, functional impair­ ment and reduced quality of life [4,21,57]

  • A mental health crisis in this study is defined as a mental health emergency, requiring an urgent response arising from a high risk of harm to self or others or a rapid increase in symptoms of psychosis or severe mood disorder, and which have a significant impact on personal or social functioning

  • This paper presents details of the trial design, intervention delivery, and research processes of the first large-scale multi-site cluster rando­ mised controlled trial of Open Dialogue, a person-centred, social network model of crisis and continuing mental healthcare

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Summary

Introduction

Mental health conditions often involve notable changes in behav­ iour, thinking and emotion associated with distress, functional impair­ ment and reduced quality of life [4,21,57]. A mental health crisis in this study is defined as a mental health emergency, requiring an urgent response arising from a high risk of harm to self or others or a rapid increase in symptoms of psychosis or severe mood disorder, and which have a significant impact on personal or social functioning. Those experiencing a mental health ‘crisis’, who are deemed to be at immediate risk to themselves (including suicide) or others or whose symptoms are rapidly worsening often require urgent specialist mental health support [53]. In the English mental health care system this led to the development of Crisis and Home Treatment Teams [31] to provide short-term, intensive support as an alternative to hospital admission, alongside Community Mental Health Teams [17] which could provide long-term care if needed

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