Self harm Mental and Behavioural Disorders Intentional self-harm
Conditions
Interventions
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
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-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
Exclusion criteria
Exclusion criteria: 1. Receiving, or having been referred to (and likely to receive this within the next 6 months), 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. Taken part in the FReSH START Feasibility study 3. Assessed by clinician to currently be unsuitable for therapy (e.g. in crisis; actively suicidal, unable to tolerate therapy - i.e. past talking treatments have resulted in severe deterioration of mental state, has a diagnosis of schizophrenia, autism, or other form of severe mental illness that would be a contraindication for the talking treatments in this study - n.b. people with schizophrenia are offered CBT but it is tailored specifically to help with psychotic experiences. The CBT in this study is not specifically tailored for the needs of people with schizophrenia) 4. Lacking capacity to comply with study requirements 5. Insufficient proficiency in English to contribute to the data collection 6. Known risk of violence (for example reported by ED or liaison psychiatry staff) 7. Researcher unable to contact potential participant within 6 weeks following self-harm event
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global distress measured using CORE-OM at 12 months from randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
England, United Kingdom
Outcome results
None listed