FReSH START – Looking at new approaches for people who self-harm

INTERVENTION: The FReSH START RCT is a 1:1 randomised controlled trial of standard care plus referral to intervention (one of three adapted therapies) vs standard care alone. It will take place across 12 sites with the aim to recruit 630 participants aged 18 years or older and reporting a self‐harm episode in the preceding three months that is at least their 3rd episode in the preceding 12 months and their lifetime 4th. To ensure that our intervention is compatible with NHS practice we will recruit through mechanisms which mirror NHS pathways. Thus we will recruit participants who present to health services by presenting at hospital Emergency Departments (ED) and are seen by liaison mental health teams. Following consent to researcher contact (C2C) the local researcher will contact the potential participant to further discuss the study. If the potential participant is interested the baseline visit will take place (this can be via phone) where eligibility is confirmed and full consent is taken. The participant is then registered. Following registration the baseline assessment will take place which includes both researcher administered and self‐completed participant questionnaires. These consist of 4 validated questionnaires and 2 non‐validated questionnaires which will be submitted for approval. The self‐completed questionnaires will be sent to the participant via an online link (paper completion is possible if preferred). Following the baseline assessments the participant is randomised. Standard care plus intervention arm: If randomised to standard care plus intervention, the participant will be allocated to a trained therapist within their site to receive one of the possible psychological therapies a CONDITION: Self harm ; Mental and Behavioural Disorders ; Intentional self‐harm PRIMARY OUTCOME: Global distress measured using CORE‐OM at 12 months from randomisation INCLUSION CRITERIA: 1. Aged 18 years or over 2. Registered with a GP in the catchment area of the mental health trust for the duration of the therapy 3. Presenting at ED as a consequence of self‐harm, defined as: intentional acts that directly harm a person's own body. This includes methods like cutting, burning, scratching, banging or hitting parts of the body, or interfering with wound healing and it also includes self‐poisoning, such as taking overdoses of drugs 4. Self‐harm episode in the preceding three months that is at least their 3rd episode in the preceding 12 months and their lifetime 4th or more episodes 5. Has mental capacity to provide fully informed written consent SECONDARY OUTCOME: ; 1. Global distress measured using CORE‐OM clinical score at 6 and 12 months; 2. Time to repetition of self‐harm leading to hospital attendance at a minimum of 12 months (HES data supplemented by clinical record check).; 3. Response to “In the past four weeks, on how many occasions have you harmed yourself” asked via monthly text message and at 6 and 12 months; 4. Hopelessness measured using the Beck Hopelessness Scale total score at 6 and 12 months; 5. Depression measured using PHQ‐9 total score at 6 and 12 months; 6. The degree to which youth feel connected to others in their social environment measured using Social Connectedness Scale‐Revised at 6 and 12 months; 7. Cost‐effectiveness outcome measures:; 7.1. Cost of health care resource use including primary, community, and social care, emergency, admitted and outpatient hospital care, cost of prescribed psychotropic medications at 6 and 12 months.; 7.2. Using utility as measured by the preference based measure CORE 6D generated from CORE‐OM at 6 and 12 months; 7.3. Incremental cost‐effectiveness ratio expressed in terms of incremental cost per quality adjusted life year (QALY) at 6 and 12 months, and at 5 years (using decision analytic modelling).; 8. Internal pilot outcome measure: Recruitment and follow‐up rates at 9 months; 9. Process Evaluation outcome measures:; 9.1. Proportion of participants attending therapy, completing the required number of therapy sessions, number of early drop‐outs from treatment, reasons for early drop outs, overall and by therapy type (CBT, ACT, PIT); 9.2. Fidelity to the safety and FReSH START components measured by therapist‐reported session checklist; 9.3. Fidelity to the safety and FReSH START components measured by researcher (from audio recordings of therapy sessions); 9.4. Researcher‐rated fidelity to therapy‐specific intervention components (from audio‐recordings of therapy sessions);