Title: Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS): A feasibility trial
Funder: Department of Health and Social Care

Abstract: Background: Self-harm (SH) is any act of intentional self-injury or self-poisoning, with or without the intention to die. People who SH are at high risk for future suicide and often suffer considerable emotional distress. Depression is common among people who SH and may be an underlying driver of self-harm behaviour. Treating depression in people who SH has the potential to reduce the risk of further SH and suicide. Self-harm is often repeated, and risk of repetition is highest immediately after an act of self-harm. Readily accessible brief talking therapies show promise in helping people who SH, but further evaluation of these approaches is needed. The Community Outpatient Psychological Engagement Service for Self-Harm (COPESS) is a brief talking therapy intervention for depression and self-harm. This intervention was shown to be feasible and acceptable in hospital emergency department settings, but accessibility was limited; thus, we wish to develop and test a community-based version of this intervention. The COPESS project moves this therapy into a community setting, thereby increasing the number of people who can be helped, especially those in hard-to-reach groups and from disadvantaged areas. Aim: To assess the feasibility of conducting a trial of the COPESS intervention in a community setting, for people with depression who self-harm, in relation to participant recruitment and retention. Therapy, acceptability and safety of the intervention will also be assessed. Methods: Using a Single Blind Randomised Control Trial (RCT) design, we will recruit a sample of n=60 participants with a history of SH within the last six months, who are also currently depressed. Recruitment will take place via GP practices for patients who: 1) seek consultation for self-harm; 2) have consulted for self-harm in the previous 6 months (determined by GPs search of their own data-systems); or 3) self-refer via their GP. Following baseline assessment participants will be randomly allocated to either receive COPESS plus Treatment as Usual [TAU; n = 30)] or TAU alone (n=30). Follow-up assessments will take place at one, two and three months. Recruitment rates, attrition and data completeness will be monitored. Qualitative interviews with participants and stakeholders will further investigate feasibility. Timelines for delivery: Set-up of project and recruitment of researcher (0-3 months); Training for GPs and therapists (0-6 months); Recruitment of patients, delivery of intervention, data collection (6-18 months); Interviews with patients, therapists and GPs (12-20 months); Data analysis (12-21 months); Write up papers and Dissemination (21-24 months). Anticipated Impact and Dissemination: The results will indicate whether it is feasible to conduct a definitive trial to determine whether COPESS is a clinically, cost-effective intervention and inform the design of any future randomised controlled trial of the COPESS intervention. The qualitative and quantitative data will help identify the potential strengths or challenges of brief community based interventions for self-harm. Dissemination of the results of the feasibility trial will be publicised in reports, peer-reviewed journals, posters and presentations. Members of the public will be invited to participate in all research activities throughout the life cycle of the project.

Lay abstract: Self-harm refers to any intentional self-injury (e.g. cutting, scratching, jumping from a height) or self-poisoning (overdose of medication or ingesting other substances), with or without the intention to end one s life. People who self-harm are at high risk of suicide, and often experience a range of social and mental health issues and considerable emotional distress. Depression is common with an estimated 70% of those who self-harm also experiencing depressive symptoms. The aim of the brief intervention being used in this study is to reduce psychological distress and future self-harm. Guidance from the Department of Health on how to help people who self-harm recommends timely access to psychological interventions. However, self-harm services are sparse and many people receive no help at all. To our knowledge, there have been no evaluations of psychological treatments for people with depression who self-harm in the UK, and it is unclear which community-based treatments might work best for people who self-harm. We have developed a brief psychological intervention called the Community Outpatient Psychotherapy Engagement Service for Self-harm (COPESS), which seeks to reduce depression and self-harm. A similar intervention has been successfully piloted in a hospital emergency department, but we plan to base COPESS in a community setting in order to increase access for people who self-harm but who do not go to hospital. We will recruit people aged 16 or over, who have depression and have recently self-harmed and randomly allocate them to either the COPESS intervention or to treatment as usual as defined within National Institute for Health and Care Excellence (NICE) guidance 2018 Managing self-harm in primary care . &ldquo;The main purpose of this study is to find out whether it is possible to recruit people to take part in this intervention, and to see if they will attend all sessions. The results from this study will help the researchers design a larger trial to assess how effective the intervention is at reducing depression and self-harm. We will therefore measure people s willingness to take part in the trial, acceptance of the intervention, completion and dropout rates for both the intervention and the trial itself, as well as safety and outcome measures following the intervention. If COPESS proves to be an effective intervention then this new model of care has the potential to be delivered more widely within the National Health Service, as an effective, low cost, convenient, safe and easily deliverable intervention.

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