Title: Remote psychosocial interventions to prevent avoidable psychiatric hospital admissions in people with serious mental health problems: a multi-arm multi-stage trial
Funder: Department of Health and Social Care

Abstract: Background: People with serious mental health problems (SMHP) are more likely to be admitted to psychiatric hospital following contact with crisis services. Existing pressure on hospital beds is made worse by the extra impact on crisis care, and hospital admissions can be traumatic. In the context of COVID-19, admitting someone to hospital can be additionally problematic. People with SMHP are vulnerable to COVID-19 due to an increased risk of underlying physical health problems, medication effects and difficulties engaging with mental health services. They may also introduce COVID-19 to the ward, or become infected on the ward, and Mental Health Trusts have to reduce number of beds in use to allow for infection prevention and control. As such, there is an urgent need for treatments to address suicidal thoughts and behaviours and, in turn, reduce avoidable hospital admissions._x000D_ Aims: To conduct a large, multi-site trial to find out which brief and remotely delivered treatments (those not delivered in person) are helpful for people with SMHP who have had recent suicidal thoughts or had a recent suicide attempt. The main question is whether the treatments are more effective in reducing hospital admissions over a 6 month period compared to usual treatment, and if these treatments provide value for money. We will also assess the impact on suicidal thoughts and behaviour, hope, recovery, anxiety and depression._x000D_ Design: We will carry out a trial that has four treatment conditions. All treatments will be delivered remotely. We will compare the following four treatment groups delivered for 3 months:_x000D_ 1) Structured peer support, which includes suicide prevention strategies based on cognitive behaviour therapy (CBT), delivered by peer support workers via telephone or video-conferencing._x000D_ 2) A safety planning approach delivered over the telephone by assistant psychologists._x000D_ 3) A CBT-based suicide prevention app for smartphones._x000D_ 4) Treatment as usual_x000D_ The group a service-user takes part in will be decided by chance. Recruitment will be based in Glasgow, Manchester, Oxford and London (East and North East). First, we will invite 200 people to participate in a smaller trial to see if there is interest for a study of this type. Depending on the results, we will then invite 1035 people to take part in the main trial. To understand whether the trial and treatments are working, we would look at the results when 559 people have been recruited. This means that if one or more of the treatments is not helpful for people, it will be removed from the trial going forward._x000D_ We will complete questionnaires with people when they start the study, at 3 months (end of treatment) and at 6 months (main outcome) to see if the treatments have been helpful. _x000D_ Patient and Public Involvement: The Psychosis Research Unit Service User Reference Group (SURG) have provided feedback on the treatments and outcomes. Peer Support Workers have also provided feedback for the process and content of the treatment groups. Several of the research team have had diagnoses of SMHP and they will be part of the Trial Management Committee. A study-specific SURG will also oversee the running of the trial. _x000D_ Dissemination: We will present results with the support of the SURG at conferences, to user groups and NHS organisations. Results will be published using academic journals, training materials, social media and service-user led organisations. An accessible report will be published online.

Lay abstract: Research question_x000D_ 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)?_x000D_ Background_x000D_ 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._x000D_ Aims / objectives_x000D_ 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._x000D_ Methods_x000D_ 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._x000D_ Timelines_x000D_ Months 1-3: study set-up_x000D_ Months 4-7: Internal pilot recruitment (total n=200)_x000D_ Months 8-22: Stage 1 trial recruitment (total n = 939 including pilot)_x000D_ Month 14: Progression criteria data presented_x000D_ Month 23: Interim analysis using first 559 recruited participants will result in one or more interventions being removed from the trial_x000D_ Months 24-29: Stage 2 trial recruitment (total n = 296). Final total sample size will be 1235_x000D_ Months 4-32: Intervention delivery_x000D_ Months 10–35: 6 month follow-up assessments_x000D_ Months 36-38: Statistical analysis and reporting_x000D_ Anticipated impact and dissemination_x000D_ 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

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH