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

Not Applicable

Active, not recruiting

• Conditions: Self harm; Mental and Behavioural Disorders; Intentional self-harm

• Registration Number: ISRCTN73357210
• Lead Sponsor: niversity of Leeds

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39187855/ (added 02/09/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-03
• Last Update Posted: 9 September 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 565

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global distress measured using CORE-OM at 12 months from randomisation