Background <p>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.</p> Methods <p>A single arm (comprising three modalities), non-controlled, multi-centre feasibility trial aimed to recruit 30 participants aged 16&#xa0;years or older and reporting both recent and recurring self-harm episodes. The FReSH START intervention included 12 individual sessions over a maximum 6&#xa0;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&#xa0;months and monthly text messages.</p> <p>A parallel qualitative study interviewed a sample of therapists and participants to refine the intervention and logic model ahead of a definitive RCT.</p> Results <p>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% (<i>n</i> = 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.</p> Conclusions <p>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.</p> <p>Trial registration.</p> <p>ISRCTN16049211.</p>

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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,
  • Adam Martin,
  • Petra Bijsterveld,
  • Judith Horrocks,
  • Suzanne Hartley,
  • Marsha McAdam,
  • Dafydd Hammond-Jones,
  • Louise D. Bryant,
  • Allan House,
  • Elspeth Guthrie

摘要

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.