Copsey, B. orcid.org/0000-0001-9783-6549, Wright-Hughes, A., Farrin, A.J. et al. (17 more authors) (2025) 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). Pilot and Feasibility Studies, 11 (1). 67. ISSN 2055-5784
Abstract
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.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
Keywords: | Self-harm, Mental health, Feasibility study, Therapy, CBT, ACT, PIT |
Dates: |
|
Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 24 Apr 2025 15:07 |
Last Modified: | 20 Jun 2025 09:14 |
Published Version: | https://pilotfeasibilitystudies.biomedcentral.com/... |
Status: | Published |
Publisher: | BMC |
Identification Number: | 10.1186/s40814-025-01644-2 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:225539 |