FReSH START RCT
Research type
Research Study
Full title
Function REplacement in repeated Self-Harm: Standardising Therapeutic Assessment and the Related Therapy (WP4 - Randomised Controlled Trial)
IRAS ID
297939
Contact name
Else Guthrie
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Self-harm is a major public health challenge with an estimated lifetime prevalence of 5-6% and 220,000 hospital attendances annually in England and Wales. Repetition of self-harm is common with 70% of hospital attenders reporting previous episodes of self-harm. An intervention that improves the quality of life of people who repeatedly self-harm and that could be delivered without the need for expensive specialist services would be of potential benefit to many who attend hospital each year. A recent Cochrane review showed little evidence for the benefit of existing therapies for people who self-harm multiple times. Therapies are intensive, of long duration, in specialist services and there is no published evidence of cost-effectiveness. The latest Cochrane review, NICE guidelines in the longer-term management of self-harm in adults and expert commentaries all point to the need for new research to test the effectiveness of interventions in this population. Despite the importance of reducing repetition, we know from working with people who have experience of self-harm that a therapeutic approach that works with service users to identify valued (positive) goals is a more acceptable approach than therapies focused on reduction of the act itself. Our approach involves modifying three existing therapies specifically for use with people who self-harm. We have selected therapies that can be easily adapted to deliver a new therapeutic approach for self-harm, have an evidence-base, and are accessible to the people who repeatedly self-harm and are seen in mainstream NHS practice. The development of the modified therapy has been done in partnership with people with experience of self-harm, and a feasibility study of 30 participants all receiving this intervention has been carried out, currently in follow-up. We are now applying for approval for a large scale definitive individually randomised controlled trial, recruiting 630 participants across 12 NHS sites.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0145
Date of REC Opinion
14 Jul 2021
REC opinion
Further Information Favourable Opinion