People who repeatedly self-harm are being offered a new type of psychological therapy designed for routine NHS care, rather than specialist clinics. Why this matters: A Cochrane review found almost no evidence on how to manage repeated self-harm in adults. The few existing trials only tested intensive, long-term therapies in specialist services for people with personality disorders, and none proved cost-effective. This leaves most patients in mainstream NHS practice without an evidence-based treatment. What the research does: The team will modify three existing therapies—behavioural activation, acceptance and commitment therapy, and psychodynamic interpersonal therapy—into a brief, trainable package. They will then run a definitive randomised controlled trial with 630 participants, comparing the new approach against standard NHS care. The primary outcome is quality of life at 12 months, measured by the CORE-OM questionnaire. Potential impact: If the therapy proves effective and cost-effective, it could become a standard NHS treatment for repeated self-harm, reaching a far wider population than current specialist-only options. This would give clinicians a practical, evidence-based tool and improve quality of life for thousands of patients who currently have no proven therapeutic option.
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Aims and Objectives, To develop and evaluate the cost-effectiveness of a new approach to psychological therapy for people who repeatedly self-harm and who are being treated in mainstream NHS practice. Background and rationale A recent Cochrane review indicates how little evidence there is on the management of repeated self-harm in adults. Seven published RCT come from specialist services and include only people with a diagnosis of personality disorder. Therapies are intensive, of long duration and require specialist therapists; there is no published evidence of cost-effectiveness. What is needed is evaluation of a therapy that can be delivered to a wider population. Our approach involves modifying three existing therapies (behavioural activation, acceptance and commitment therapy, psychodynamic interpersonal therapy), training therapists in their use and conducting a definitive Phase 3 RCT with an internal pilot, cost-effectiveness analysis and process evaluation. Research plan, Work Package 1: Develop initial training package Work Package 2: Testing implementation of the training package Work Package 3: Non-randomised feasibility study Work package 4: Definitive RCT with internal pilot and process evaluation WP1a A Q methodology study with adult participants with personal experience of repetitive self-harm. Participants will complete a Q sort of reasons for self-harm online. Interview with a sub-sample of respondents online or by telephone about their choices. WP1b: Systematic review of self-reported accounts of means of recovery from repeated self-harm - will support development of a portfolio of alternative activities to be discussed in therapy. WP1c: Facilitated consensus groups will develop supporting materials for the therapeutic assessment and subsequent therapy, formulate how best to integrate the self-harm assessment into each of the three different therapies and explore the challenges of incorporating into NHS care pathways. Groups will develop a brief three-day training programme for each therapy. WP2a: A National survey of provision of candidate therapies will identify provision of the three therapies of interest, seek expressions of interest from therapists and identify NHS sites for participation in the RCT. WP2b: Semi-structured interviews will explore therapists experience of the training once delivered. Interviews with service leads will explore the challenges of incorporating our approach into existing care pathways. WP3a: A non- randomised single arm feasibility study in 30 participants across three sites will test delivery and development of the intervention, whilst refining processes for the subsequent definitive trial. We will assess recruitment, follow-up, intervention delivery & acceptability rates, with clear progression criteria based on a traffic light system. WP3b: An interview and observational study (with the consent of participants, each therapy session will be audio-recorded) will explore with therapists and participants receiving the intervention their experience of assessment and therapy. WP4a: Definitive RCT with internal pilot – an individually 1:1 randomised controlled trial N= 630 of referral to experimental therapy vs NICE compliant Treatment as Usual, with internal pilot. Randomisation will use minimisation, stratified for site, sex, referral source, time since first episode, and possibly CORE-OM score (dependent on ranges seen in the feasibility study). Primary outcome will be 12 month Quality of life using Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM). Secondary outcomes will include measures of reliable and clinically significant improvement on the CORE-OM; repetition of self-harm; hopelessness; depression; social connectedness; Quality-adjusted life years (QALYs), using utility as measured by the preference based measure CORE 6D generated from CORE-OM; ; Self-reported resource use– primary and community care and medications and private fi
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