Results of a feasibility study of the FReSH START intervention to improve quality of life and other outcomes in people who repeatedly self-harm (Function REplacement in repeated Self-Harm: Standardising Therapeutic Assessment and the Related Therapy).

Background: Self-harm is a major public health challenge with 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 self-harm. Multiple repetition bears a significant cost to individuals and healthcare systems. A recent Cochrane review showed little evidence for the benefit of existing psychological therapies for people who repeatedly self-harm. Considering multiple possible functions of self-harm, we modified three existing psychological therapies for use with people who self-harm multiple times. To inform the design of a definitive multi-centre randomised controlled trial (RCT) and assess the feasibility of an RCT, this mixed-methods feasibility study assessed intervention delivery and acceptability.

Methods: A single arm (comprising three modalities), non-controlled, multi-centre feasibility trial aimed to recruit 30 participants aged 16 years or older and reporting both recent and recurring self-harm episodes. The FReSH START intervention included 12 individual sessions over a maximum 6 months comprising one of three psychological therapies, each modified specifically for use with people who have self-harmed multiple times: Cognitive Behavioural Therapy, Acceptance and Commitment Therapy, and Psychodynamic Interpersonal Therapy. Follow-up was via participant reported outcomes using postal questionnaires at 6 months and monthly text messages. A parallel qualitative study interviewed a sample of therapists and participants to refine the intervention and logic model ahead of a definitive RCT.

Results: We reached our target of 30 recruited participants and 15 therapists delivered the intervention in a way that was acceptable to participants. However, follow-up rates for the 6-month questionnaire were lower than expected at 53.3% (n = 16/30). To improve follow-up, in the definitive RCT, we plan to use online questionnaires, provide vouchers and behaviourally-informed letters to incentivise questionnaire return, and include follow-up via routinely collected data. Intervention fidelity also requires some improvement in specific areas; thus we plan to amend the intervention therapist training accordingly.

Conclusions: Despite disruption due to the COVID-19 pandemic, we conclude that delivery of a definitive trial of adapted psychological therapies for people who repeatedly self-harm is feasible with modifications to study processes to improve intervention fidelity and participant retention.

Trial Registration: ISRCTN16049211.