Title: The Self-harm, Assessment, Formulation, Engagement Trial of Psychodynamic Interpersonal Therapy (SAFE-PIT)
Funder: Department of Health and Social Care

Abstract: Aims_x000D_ We want to find out whether a type of brief therapy, psychodynamic interpersonal therapy (PIT), helps people who attend an emergency department (ED) after an episode of self-harm (SH), over and above NHS best care. We are interested in whether PIT helps people reduce future SH, ED attendance and improve their mental health and quality of life. We will also measure costs and potential cost-savings as this is important for the NHS. _x000D_ _x000D_ Background_x000D_ Intentional non-fatal self-harm usually involves taking an overdose of tablets, cutting or burning. People who SH are emotionally distressed and often suicidal. Nearly 9 out of 10 episodes of SH are triggered by relationship problems. Over 200,000 people attend EDs each year following SH, but a recent survey has shown that most are not offered any psychological therapy. Two recent reviews have suggested that brief therapy may be beneficial for SH but larger studies are required to be certain. We have chosen to focus on PIT as it addresses psychological distress and relationship problems, has been shown in a previous smaller study to help people who SH, and has been used for many years in SH services in the North of England. Another therapy called CBT has also been shown to help people who SH, but there are many studies involving CBT and a further trial may not add much to what we know already. User groups also strongly support greater choice of therapy in the NHS._x000D_ _x000D_ PIT therapy involves 4 weekly sessions (+ 2 optional booster sessions) and is intended for people who have 3 or fewer prior episodes of SH. People who SH more frequently require more intensive treatment and we have a separate study which will assess a more intensive treatment for this group. Best care involves a full psychosocial assessment and a care plan. _x000D_ _x000D_ The research_x000D_ Mental health nurses who work in EDs will approach people who have attended hospital following SH to see if they are interested in taking part in the study. We will check that people are suitable for the study and those who agree will be allocated by chance to one of 2 groups; PIT as well as best care or best care only. We will use data from a national source to find out if people have attended ED again with SH over the follow-up period (between 12 -36 months depending when people enter the study). We will also ask all people to complete follow up assessments at 6 and 12 months to find out how they are, in terms of their mental health and quality of life, and what services they have used. We can then decide if PIT is cost-effective for the NHS._x000D_ _x000D_ Patient and public involvement (PPI)_x000D_ We have involved people with experience of SH in this grant application and have a co-applicant who has personal experience of SH and considerable experience of raising awareness and advocating for better mental health care._x000D_ _x000D_ The team_x000D_ We are a team of psychiatrists, trialists and users of SH services. We have experience of conducting previous trials of psychological therapies for SH and of running psychological treatment services for people who SH in the NHS. _x000D_ _x000D_ Dissemination_x000D_ We will publish the results via academic journals and meetings, and social media. We will target relevant user organisations and we will work with our PPI co-applicant to present information in a clear format. Several of us have national roles which will enable the results (if favourable) to be fast-tracked into national policy, one of the best ways of making the treatment available on the NHS.

Lay abstract: RESEARCH QUESTION: Is brief psychodynamic interpersonal therapy (PIT) plus best care effective for people who attend hospital following self-harm (SH) compared to best care?_x000D_ BACKGROUND: SH is associated with high rates of psychological morbidity, poor quality of life and increased suicide risk. Lack of a definitive trial of psychological therapy for SH has limited the development of services._x000D_ AIMS AND OBJECTIVES: To determine the clinical and cost-effectiveness of PIT plus best care compared to best care alone. _x000D_ METHODS_x000D_ Design: Multicentre RCT with embedded qualitative study, internal pilot and cost-effectiveness analysis. _x000D_ Health Technology: 4 sessions of manualised PIT (+ optional 2 booster sessions). Best care according to NICE consists of a psychosocial and risk assessment and care plan. _x000D_ Participants will be individually-randomised (1:1) via stratified minimisation with random element._x000D_ Setting: 12 hospital Emergency Departments (EDs) with liaison mental health teams._x000D_ Population: Adults 18 years and over who attend hospital after intentional SH with a history of <3 prior episodes, not all in last year. Exclusions: involved in other intervention research; having therapy; risk of violence; lacks capacity to consent; requiring urgent in-patient psychiatric treatment. _x000D_ Data collection: self-completed via web/postal (baseline, 6, 12 months), HES data over trial duration (minimum 12 month follow-up)._x000D_ Outcomes: Primary - time from randomisation to first hospital episode of SH. _x000D_ Secondary - hospital and self-reported SH; psychological distress (CORE-OM), anxiety (GAD-7), hopelessness (BHS) and interpersonal problems (IIP-32) at 6 and 12m; safety. _x000D_ Economic evaluation: Within trial cost-effectiveness at 12m, Decision Analytic Model over 5 years and a longer lifetime perspective using QALYs based on ReQOL; outcome and costs from both the standard NHS and PSS perspective and a wider societal perspective. _x000D_ Nested qualitative study: Interviews with 40 purposively sampled PIT participants and 24-30 therapists/service leads, guided by Normalisation Process Theory to explore experiences, process and challenges incorporating PIT into clinical practice._x000D_ Sample size: 770 participants in total provide 90% power (5% 2-sided alpha) to detect a hazard ratio of 0.637 indicating the relative likelihood of a hospital SH repetition in PIT versus control participants. This assumes 12m repetition 35% vs 24%; 5% loss to follow-up (HES linkage); clustering, 35 therapists treat ~11 participants (range 3-15); ICC of 0.02 and design effect of 1.2. Numbers are based on 12-18m follow-up, with no assumption for events beyond 18m. Sample size provides 90% power to detect a standardised effect size of 0.3 on secondary outcomes (reduction<3 CORE-OM points) with 25% loss to follow-up._x000D_ Analysis: ITT analysis - Cox Proportional Hazards Frailty Model, adjusted for randomisation factors and random therapist effect, will estimate the treatment effect on the primary outcome reported as the hazard ratio with 95% confidence intervals and p-values. Recurrent event analysis and mixed multi-level regression will estimate treatment differences for secondary outcomes. Missing data will be imputed via multiple imputation where appropriate. _x000D_ TIMELINES FOR DELIVERY: 56 months: 10m Set-up; 24m Recruitment (12m internal pilot); 12m Follow-up; 10m Data cleaning, analysis, write-up. _x000D_ DISSEMINATION: Academic, clinical, national policy and service user audiences. _x000D_ IMPACT: Substantially improved care for people with SH

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