Self harm Mental and Behavioural Disorders
Conditions
Interventions
The SafePIT RCT is a 1:1 randomised controlled trial of standard care plus referral to intervention vs standard care alone. A total of 770 participants will be recruited across 12 sites (Mental Health
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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-harmed 1-2 times in the last 12 months (any amount in their lifetime) OR self-harmed exactly 3 times in the last 12 months but never before this year. 5. Mental capacity to provide fully informed written consent
Exclusion criteria
Exclusion criteria: 1. Receiving, or having been referred to, a specific psychological intervention that is similar to the trial intervention, or where a specific intervention is indicated for a related condition (e.g. anorexia nervosa or drug addiction) and would conflict with trial participation. 2. Assessed by clinician as currently unsuitable for therapy (e.g. in crisis; actively suicidal) 3. Lacking capacity to comply with study requirements 4. Insufficient proficiency in English to contribute to the data collection 5. Known risk of violence (for example reported by ED or liaison psychiatry staff) 6. Researcher unable to contact potential participant within 6 weeks following self-harm event
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (in months) from randomisation to first repetition of self-harm leading to hospital attendance, obtained from HES data supplemented by clinical record check. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of repetition of self-harm leading to hospital attendance at 6 and 12 months, obtained from HES data supplemented by clinical record check. 2. Time (in months) from randomisation to repetition of self-harm leading to hospital attendance (all events), obtained from HES data supplemented by clinical record check. 3. Rate of repetition of self-reported self-harm at 6 and 12 months, obtained via monthly text message and 6 and 12-month questionnaires. 4. Psychological distress as measured by (CORE-OM) at 6 and 12 months. 5. The proportion of people with clinically significant improvement (and deterioration) on CORE-OM at 6 and 12 months. 6. Anxiety as measured by the Generalised Anxiety Disorder-7 (GAD-7) at 6 and 12 months. 7. Hopelessness as measured by the Beck Hopelessness Scale (BHS) at 6 and 12 months. 8. Interpersonal function measured by the Inventory of Interpersonal Problems (IIP-32) at 6 and 12 months. 9. Quality of life as measured by the ReQoL-10 at 6 and 12 months (with comparison to EQ-5D-5L and CORE-6D measures). 10. Health care use, measured by a structured health-resource–use questionnaire and HES data, over 12 months post-randomisation. 11. QALYs based on ReQOL at 6 and 12 months. Internal Pilot Outcome Measure: 1. Recruitment and intervention delivery at 12 months. Qualitative Evaluation Outcome Measures: 1. Thematic analysis of interviews of participants and/or their supporters regarding experience of receiving the therapy. 2. Thematic analysis of interviews of the therapists’ experience of participating in the trial. 3. Logic model of interviews of the service managers and therapists of how the intervention was delivered and the implications for sustaining the intervention in future. | — |
Countries
England, United Kingdom
Outcome results
None listed