Title: An online randomised controlled trial to evaluate the clinical and cost effectiveness of a peer supported self-management intervention for relatives of people with psychosis or bipolar disorder: Relatives Education And Coping Toolkit (REACT)
Funder: Department of Health and Social Care

Abstract: We propose a single blind 2 arm pragmatic online RCT to compare “REACT (including Resource Directory) +Treatment As Usual ” versus “Resource Directory +Treatment As Usual“. REACT is an online self-management intervention for relatives (defined as family or friends) of people with psychosis/BD, supported by Expert Relatives. The Resource Directory (RD) provides information on how to access all currently available online support. Eligibility criteria are as inclusive as possible and require relatives to be over 18, living in the UK, supporting someone with psychosis/BD, distressed, help seeking, and connected to the internet. Recruitment will be national through a wide range of routes including NHS services, third sector organisations, and self-referral. Following online consent relatives will complete baseline measures prior to individual randomisation. Three and 6 months after randomisation, relatives will be invited to repeat the measures and analysis will be a direct comparison under the intention to treat principle between the 2 arms adjusting for baseline scores. The primary outcome is relatives’ distress (GHQ-28) and secondary outcome is carer well-being and support (CWS). An adapted version of the Client Service Receipt Inventory (CSRI) will assess treatment as usual, and inform a cost effectiveness analysis. Cost utility using quality adjusted life years will be assessed using the EQ-5D-5L. Based on feasibility data, and accommodating for design adaptations, we estimate the mean difference between arms to be 5.0 units (s.d. 16.60). A conventional power calculation shows us that a total sample of 466 participants would give us 90% power to reject the null hypothesis (p<.05) when the true effect size is 5.0 units. Based on a review of online trials [17] we allow for a 30% dropout rate, although we describe a number of strategies we will employ to reduce this. Our total sample size becomes 666. Our estimated total population size of relatives of people with psychosis/BD (total 750,000), regularly using the internet (76%), and showing significant levels of distress (approx. one third) is 190,000 relatives. Our recruitment strategy is broad and over 18 months so, based on recruitment rates from other online trials, we are confident we can achieve this. Our team has extensive methodological experience in conducting large RCTs (Liverpool CTU, Hollingsworth) specifically in mental health (Lobban/Jones/Johnson) and in online trial methodology (Murray). We include a relative with expertise in using her lived experience to inform research, and clinical service development (Minns).

Lay abstract: Psychosis and bipolar disorder are very serious mental health problems, which affect over 6 million people in the UK. Relatives (family and friends) provide the vast amount of care, which would otherwise cost the NHS over a billion pounds each year. However, this caring role also puts high levels of practical, financial and emotional strain on relatives who often struggle to cope. The UK government have made a commitment to assess the needs of relatives and provide them with the information and support they need. However, finding ways to provide this support is a challenge. Structured face to face Family Interventions have been shown to be both clinically effective (i.e. they work) for both service users and relatives, and cost effective (i.e. they are worth the cost of delivering them), but they are very hard to access in clinical services, and support for relatives is often very poor. REACT is an online toolkit that provides relatives with the information and support they need. It was co-designed with relatives, consists of easy to navigate modules, and is supported online by Expert Relatives (experts by lived experience) and peer support forums. NIHR funded the development and feasibility testing of the intervention in a small trial in the North West of England, which showed that REACT was acceptable to relatives, and reduced their distress. We have adapted the toolkit in light of feedback and designed an online trial to test its clinical and cost effectiveness across the UK. In the online trial, relatives will be directed to the study website through a wide range of routes including clinical services, voluntary sector organisations, and web searches. We plan to recruit 666 relatives who will be allocated at random to either receive access to the REACT website, or to an online Resource Directory which includes information about all currently available services. They will be asked to complete questionnaires to assess their distress levels and wellbeing at the beginning, and after 3&6 months. We will test whether there is a difference in how REACT or the Resources Directory impact on distress and wellbeing levels. Collecting the data online means that the trial costs a lot less to run (£636,204) than if it was done face to face (£2,032,667). Our team has considerable expertise in running large online trials and in supporting people with mental health problems and their relatives and we are confident we can successfully deliver this trial.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH