Self-harm Mental and Behavioural Disorders Intentional self-harm
Conditions
Interventions
The FReSH START feasibility study is a single-arm trial, taking place across three sites, aiming to recruit 30 participants aged 18 years or older and reporting a self-harm episode in the preceding th
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults 18 years or over 2. Presenting at ED, adult mental health services or general practice as a consequence of self-harm within the last 8 weeks, 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 3. Self-harm episode in the preceding 3 months that is at least their 3rd episode in the preceding 12 months and their lifetime 4th. 4. Has mental capacity and provides fully informed written consent
Exclusion criteria
Exclusion criteria: 1. Receiving a specific psychological intervention or where a specific intervention is indicated for a related condition (e.g. anorexia or drug addiction) 2. Refuses to provide fully informed written consent 3. Lacks capacity to comply with study requirements 4. Insufficient proficiency in English to contribute to the data collection 5. Known risk of violence 6. Researcher unable to contact participant within 8 weeks following self-harm event
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The outcomes relate to intervention delivery and acceptability, feasibility of recruitment, follow-up and outcome data collection, as follows: Intervention delivery and acceptability: 1. Number and proportion of therapists undergoing training and deemed competent 2. Therapy delivery by randomly allocated therapist, cross over of patients to therapists 3. 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 (BA, ACT, PIT) 4. Availability and uptake of other treatments and services accessed by participants 5. Proportion of participants taking up telephone “top up” contact at end of therapy 6. Proportion of participants and therapists delivering key intervention components, overall and by therapy type (BA, ACT, PIT) as recorded by the therapist 7. Participant and therapist fidelity to the intervention including fidelity to the self-harm modifications and to the individual psychological therapeutic approach overall and by therapy type (BA, ACT, PIT) as recorded by the researcher rated audio-recordings 8. Number and attendance of therapy-specific supervision sessions Recruitment methods, uptake and follow-up: 1. Number of patients screened for eligibility 2. Number of study cards given out and proportion completed 3. Method of referral e.g. Emergency Department, self-harm team, clinical staff, general practice 4. Proportion of patients that could be followed-up by the Researcher and proportion of those found eligible for the study 5. Proportion of patients that consent and are registered to the study out of those found eligible 6. Reasons for non-participation 7. Proportion of patients completing the study out of those registered, number of withdrawals from follow-up data collection, reasons for withdrawal 8. Number of losses to follow-up and characteristics of participants lost to follow-up Follow-up data collection: 1. Propo | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactAaron Dowse
Outcome results
None listed