Evidence map›Paper›PMID 40375344›Full record

ArticlePilot and feasibility studies2025

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).

Bethan Copsey, Alexandra Wright-Hughes, Amanda Farrin, Cara Gates, Kate Farley, Cathy Brennan, Dean McMillan, Christopher D Graham, Chris Bojke, Richard Mattock and 10 more

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Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

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0cells of the map it votes in
4citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Bethan CopseyClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK. b.copsey@leeds.ac.uk.ORCID http://orcid.org/0000-0001-9783-6549
Alexandra Wright-HughesClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Amanda FarrinClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Cara GatesLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Kate FarleyLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Cathy BrennanLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Dean McMillanDepartment of Health Sciences, University of York, York, UK.
Christopher D GrahamDepartment of Psychological Sciences & Health, University of Strathclyde, Glasgow, UK.
Chris BojkeAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Richard MattockAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Adam MartinAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Petra BijsterveldClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Judith HorrocksClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Suzanne HartleyClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Marsha McAdamClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Dafydd Hammond-JonesLeeds Teaching Hospitals NHS Trust, Leeds, UK.
Louise D BryantLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Allan HouseLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Elspeth GuthrieLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
FReSH START lived experience group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSelf-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.

methodsA 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.

resultsWe 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.

conclusionsDespite 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 registrationISRCTN16049211.

Indexed as

ACTCBTFeasibility studyMental healthPITSelf-harmTherapy

Identifiers

PMID40375344
PMCPMC12080260

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.