COPe-support - a multi-component digital intervention for family carers for people affected by psychosis: study protocol for a randomized controlled trial

Jacqueline Sin,Steve Gillard,Jack Elkes,Rachel Batchelor,Claire Henderson,Tao Chen,Victoria Cornelius,Luke A Woodham,Dominique Spence-Polin,Aurora Sesé Hernández

doi:10.1186/s12888-020-02528-w

Abstract

BackgroundPsychosis often causes significant distress and impacts not only in the individuals, but also those close to them. Many relatives and friends (‘carers’) provide long-term support and need resources to assist them. We have co-produced a digital mental health intervention called COPe-support (Carers fOr People with Psychosis e-support) to provide carers with flexible access to high quality psychoeducation and interactive support from experts and peers. This study evaluates the effectiveness of COPe-support to promote mental wellbeing and caregiving experiences in carers.MethodsThis study is a single-blind, parallel arm, individually randomized controlled trial (RCT) comparing COPe-support, with attention control. Both groups continue to receive usual care. COPe-support provides interactive web-based psychoeducation on psychosis-related issues, wellbeing-promotion and network support through forums. The attention-control is a non-interactive online information resource pack. Carers living in England are eligible if they provide at least weekly support to a family member or close friend affected by psychosis, and use internet communication (including emails) daily. All trial procedures are run online, including collection of outcome measurements which participants will directly input into our secure platform. Following baseline assessment, a web-based randomization system will be used to allocate 360 carers to either arm. Participants have unlimited access to the allocated condition for 40 weeks. Data collection is at three time points (10, 20, and 40 weeks after randomization). Analyses will be conducted by trial statisticians blinded to allocation. The primary outcome is mental wellbeing measured by Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), at 20 weeks. As well as an intention-to-treat analysis, a complier average causal effect (CACE) analysis will be conducted to estimate the intervention effect in participants who have accessed COPe-support content twice or more. The secondary objectives and analysis will examine other health and caregiving-related outcomes and explore mechanisms. In a process evaluation, we will interview 20% of the intervention arm participants regarding the acceptability of COPe-support. We will explore in detail participants’ usage patterns.DiscussionThe results of this trial will provide valuable information about the effectiveness of COPe-support in promoting wellbeing and caregiving experiences in carers.Trial registrationThe RCT is registered with the Current Controlled Trials registration (ISRCTN 89563420, registration date: 02/03/2018).

Highlights

Psychosis often causes significant distress and impacts in the individuals, and those close to them
Despite clinical guidelines recommending psychoeducation, especially those delivered to carers using a group format as an effective support for carers, its provision remains scarce [2, 16]
Given carers’ wellbeing is correlated with their caregiving capacity, which can affect the quality of support the cared-for person receives, it is paramount that carers have access to an effective treatment

Summary

Introduction

Psychosis often causes significant distress and impacts in the individuals, and those close to them. Many relatives and friends (‘carers’) provide long-term support and need resources to assist them. In the UK, it is estimated that approximately 1.5 million people are caring for a family member or friend with a mental illness [2,3,4]. Of these illnesses, psychosis is recognised as among the most common and severe [2, 3]. The responsibility of caring often means that carers of people with psychosis experience high levels of distress and increased vulnerability to ill health [9,10,11,12]. Carers who are unwell themselves or feel they lack resources to cope are less likely to engage in caring for their loved ones in a positive manner [6]

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