Title: Women Offenders Repeat Self-Harm Intervention Pragmatic Trial: WORSHIP III
Funder: Department of Health and Social Care

Abstract: Design: An RCT of Psychodynamic Interpersonal Therapy vs. treatment as usual for self-harming women in prison. Setting: 7-8 UK women’s prisons. Population: Self-harming women in prison. Inclusion: Experiencing self-harm thoughts and on an ACCT in the last month; self-harm in the last month; 18 years or older. Exclusion: Lacking capacity to consent; too distressed or unwell to participate; likely to remain less than 8 weeks in prison; risk of harm to others. Technology: 4-8, 50-minute sessions of manualised PIT adapted for self-harming women prisoners; delivered by supervised psychology/psychiatry trainees. PIT focuses on managing emotions and relationships. Outcomes: Primary: self-harm incidents at 8-weeks (prison records/self-report). Secondary: level of harm caused by self-harm incidents (e.g. requires hospitalisation); self-harm thoughts; BSSI; BDI; BHS; WEMWS; RSES; EQ-5D-5L or SF12. Scales will be completed at baseline/8 weeks from baseline/12 weeks from baseline. There will be an internal stop/go pilot lasting 12 months to assess recruitment, fidelity and treatment completion. Analyses: intention-to-treat following CONSORT principles. Generalised linear mixed models will be fitted to the primary and secondary outcomes, including a random intercept for therapist, and baseline outcome measure and site as fixed effects. There is currently no information on the costs of self-harm in women’s prisons. The incremental cost-effectiveness of PIT vs. TAU will be estimated from a public sector perspective. Secondary analysis will estimate the cost per self-harm-incident averted. Resource use will be collected using SFSUS/bespoke measure from prison/medical notes and self-report. Modelling of potential future costs/benefits of PIT/TAU will be performed. Qualitative: interviews will be completed with prisoners at the end of the pilot (N=12-20) and intervention (N=40) to explore which aspects of PIT/TAU work. Staff focus groups in all prisons (N=7) will explore perceptions of PIT/TAU. Data will be analysed using framework analysis. Size: For comparison of PIT/TAU, calculations are powered to detect a minimal important clinical difference of 33% reduction in self-harm incidents. From MOJ, the average number of self-harm episodes over 8 weeks in the control group was 6.65. We used Monte Carlo simulations with 1000 simulations to estimate the power for a range of sample sizes, with power defined as the proportion of estimated p-values less than 0.05 for null hypothesis testing (treatment effect is 0), against an alternative hypothesis (33% reduction in the outcome log count). With 5% significance, to obtain 90% power, we will require 105 per group for the primary analyses. Based on WORSHIP II we estimate 20% attrition so will recruit 132 per group at baseline. Difference from current care: No standardised, evidence-based self-harm care pathway exists in prisons. Interventions such as CBT are used, but are rarely targeted for self-harm; with none formally evaluated. PIT is targeted and evidence-based. Timetable: Set up (mths 1-9); Pilot (10-21): N=54 based on WORSHIP II [25]; Stop/go (22); Recruit/follow up: N=210 (23-46); quantitative analysis (47-50) qualitative analysis (47-48); write up (49-54); health economics (1; 22; 47-54). Expertise: Gendered mental health (KA), prison research (KA/KG/LR/JS/TW/EP/AB), service user (FE), forensic practice (LR/AB/JS), statistics (RE), health economics (RM) implementation (KL/SA); HMPPS Deputy Director (LS); Prison Governor (MM).

Lay abstract: Aim: To see if a talking therapy developed with women and prison staff for prisoners who self-harm, Psychodynamic Interpersonal Therapy (PIT), will lead to less self-harm and be value for money for the NHS and improve the lives of women who self-harm in prison. Background: Self-harm is an important, growing problem in prisons, especially for women. Only 5% of prisoners are women but they carry out over a quarter of prison self-harm. There are many reasons for self-harm, such as managing distress, trying to control emotions and self-punishment. People who self-harm are more likely to attempt suicide than those who do not. Although self-harm rates are high, there are currently no treatments which have been properly tested in prisons. In PIT, people discuss their feelings, their relationships and how their past has influenced them. The aim is to help them find new ways to manage emotions and relate to others. PIT has been shown to reduce depression, suicidal thoughts and self-harm incidents in the community. It is especially helpful for people who have experienced childhood trauma. Women in prison often have experienced damaging relationships and trauma meaning it should be a therapy well-suited to their needs. We have already adapted PIT for use in prisons and consulted women prisoners who liked the therapy and found it helpful. We also conducted a small feasibility randomised controlled trial (RCT) in three women’s prisons. In an RCT, people are allocated either to the treatment or control group (not having the treatment) and the outcomes are compared. The research showed that running a larger RCT is possible. Based on this study, we want to test if PIT will reduce self-harm incidents. Design/Methods: We shall conduct the RCT in 7-8 women’s prisons, comparing PIT to the treatment already available e.g. self-esteem courses. Therapy will be delivered by supervised clinical/forensic psychology and psychiatry trainees. PIT will last for 4-8, 50-minute sessions, depending on a woman’s preference. We want to find out if PIT reduces self-harm incidents more than usual treatment. We shall collect this information from prison records and the women. We are also interested in the effect of PIT on the level of harm caused by self-harm incidents, self-harm thoughts, mood, hopelessness, suicidal thoughts, self-esteem and wellbeing. We shall measure these before treatment, after treatment ends (8 weeks) and 12 weeks after the start. When the RCT ends, we shall interview 40 women to see how they found PIT (20) or usual treatment (20). We shall also interview staff to find out their views on PIT. Patient/public involvement: Women who have self-harmed in prison are involved in the research. We have a service user co-applicant who has helped develop this application and an established service user group. They will all join the research management group, co-producing any research materials and advising on research conduct. Our service user co-applicant will help analyse the research interviews and share findings. As in our past research, we shall have current prisoners on the steering group. Dissemination: Findings will be shared with participants and other women in prison e.g. circulating easy-read articles, via prison radio interviews and running dissemination events. We shall present at key conferences, including our own. Contacts in the Her Majesty’s Prison and Probation Service, Public Health England and NHS agree we can share the research at key meetings.

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