Remote psychosocial interventions to prevent avoidable psychiatric hospital admissions in people with serious mental health problems: a multi-arm multi-stage trial

Research question Which brief, remote psychosocial interventions for people with Serious Mental Health Problems (SMHP) who report recent suicidal ideation or a suicide attempt are most clinically effective and cost-effective in preventing avoidable admissions in comparison to treatment as usual (TAU)? Background People with SMHP are more likely to be admitted to psychiatric hospital following contact with crisis services (Home Based Treatment Teams: HBTTs). Admissions can have significant personal costs and be traumatic, and are the most expensive form of mental health care. In the context of COVID-19, admitting someone to hospital can be problematic, since people with SMHP are potentially vulnerable to COVID-19 due to an increased risk of underlying physical health problems and medication side effects. There is a need for treatments to reduce suicidal thoughts and behaviours and, thereby, reduce avoidable hospital admissions. Aims / objectives We aim to conduct a 4-arm, 2 stage randomised controlled trial comparing 3 brief, remote interventions to TAU. We hypothesise they will lead to a reduction in psychiatric hospital admissions over 6 months (primary outcome) and reductions in suicidal ideation, and be cost-effective over 6 months. Methods We will recruit adults with a SMHP diagnosis and have had recent suicidal thoughts or behaviours from HBTTs across 4 UK cities with high levels of diversity and social adversity. Each intervention will be delivered remotely over a 3-month treatment window. The treatments are: structured peer support, which includes suicide prevention strategies from cognitive behaviour therapy, remotely delivered by peer support workers; a safety planning approach delivered remotely by assistant psychologists; and a CBT-based suicide prevention app for smart phones. All participants will receive TAU from HBTTs. Assessments will be conducted at baseline, 3 months and 6 months (primary endpoint). The multi-arm, multi-stage design enables early identification, and subsequent removal, of the least effective novel intervention, thereby increasing trial efficiency. In Stage 1, we will randomise participants, stratified by site, in the ratio 2:1:1:1 in favour of TAU using an independent randomisation system. An interim analysis will be performed using data from the first 559 participants. This will result in one or more arms being dropped for lack of benefit in Stage 2, with subsequent change to the allocation ratio of future participants to 2:1:1. Stage 1 includes an internal pilot. Timelines Months 1-3: study set-up Months 4-7: Internal pilot recruitment (total n=200) Months 8-22: Stage 1 trial recruitment (total n = 939 including pilot) Month 14: Progression criteria data presented Month 23: Interim analysis using first 559 recruited participants will result in one or more interventions being removed from the trial Months 24-29: Stage 2 trial recruitment (total n = 296). Final total sample size will be 1235 Months 4-32: Intervention delivery Months 10–35: 6 month follow-up assessments Months 36-38: Statistical analysis and reporting Anticipated impact and dissemination This research will provide evidence regarding remote psychosocial interventions to help people experiencing suicidal ideation and SMHP, which are both causes of disability and mortality. It will provide manualised interventions and training materials, which will facilitate effective uptake, implementation and sustainability in the NHS