Award Title: Function REplacement in repeated Self-Harm: Standardising Therapeutic Assessment and the Related Therapy: FReSH START
Funder: Department of Health and Social Care

Abstract: 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 financial burden due to self-harm. Analysis will be by intention-to-treat, with no planned interim analysis. We will undertake a within-trial cost-effectiveness analysis using QALY as the outcome measure. WP4b: A process evaluation will explore the process of implementation of the therapeutic approach across sites and therapists.     Projected outputs & dissemination plans A novel clinical assessment for people who repeatedly self-harm . A training programme to broaden the range of therapies, and therapists, available to people who self-harm and do not need to have either a diagnosis of personality disorder or treatment in a specialist clinic. RCT evaluation of a widely applicable therapeutic approach. Dissemination will be via academic publications and presentations. We will facilitate knowledge transfer through sustained contact with clinical services and clinical commissioning groups nationally throughout the programme of work. The PI is an Expert Adviser for the NICE Centre for Guidelines and will ensure the findings are included in future revisions. Via our PPI we will ensure the results are available to service user groups. If the therapy is effective we will produce plans for distribution of training and materials in the NHS.   Benefits to patients and the NHS PPI, embedded throughout the programme through involvement of our two co-applicants and an advisory group, will ensure the training programme and therapy-delivery is tailored to the needs of service users. The benefit to the NHS will be the first ever cost-effectiveness analysis of therapy for repeated self-harm.

Lay Abstract: Multiple repetition of self-harm is common and is associated with poor quality of life and with an increased risk of suicide even when the immediate reported reason for an act is not attempted suicide. There is currently no treatment, deliverable in mainstream mental health services, that works well for individuals with a history of multiple repetition. The aim of this programme of research is to develop and evaluate a new approach for helping individuals who repeatedly self-harm - based upon changing existing therapies so they are more useful in helping people who repeatedly self-harm.   Current treatment tends to focus on the act of self-harm as a symptom of underlying distress. However, personal accounts of reasons for repetition also identify positive motivations such as feeling a stronger person or feeling more in control of one s life. We wish to develop a new approach that can accommodate all potential motivations and allow therapists and service users to identify, and work with, these positive functions. A goal of therapy is then to explore what these functions of self-harm say about an individual s values and help consider new ways to achieve change that reflects those values.   There are a number of current therapies that work with service users on personal goals and values; Behavioural Activation (BA), Acceptance and Commitment Therapy (ACT) and Psychodynamic Interpersonal Therapy (PIT). We want to adapt these therapies so they are more appropriate for individuals who repeatedly self-harm.   We will first develop an acceptable assessment that can be used to help individuals think about what benefits they gain from self-harm. It is widely known that service users find it difficult to say why they self-harm. Q methodology is a way to make this easier, and we will use it to ask people how their own experience relates to reasons for self-harm reported by others - we have identified many such reasons from a recently completed review of first person accounts of reasons for self-harm, and an analysis of social media postings. The output from this initial work will be a new way of describing reasons for self-harm, from the service user s perspective.   We will review published self-reported accounts of recovery both in the published literature and on social media. We will then work with experienced therapists and service users to establish how to incorporate the new assessment and what we know about self-reported reasons for change, into therapy.   We will then develop a training programme for therapists who already have some training or experience in the approaches to support them in using the materials with individuals who repeatedly self-harm.  After identifying and training suitable therapists we will evaluate the effectiveness of this approach in a Randomised Controlled Trial.

Research Activity Codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health Categories: MENTAL HEALTH