A 10-session talking therapy is being tested against standard NHS care for people with personality disorder, to see if a brief intervention can improve their social functioning over a year. Current NICE-recommended treatments for personality disorder are lengthy and intensive, leaving many patients unable or unwilling to access them. This creates a gap: low-intensity options could be more inclusive, but no robust evidence exists on whether they actually work. The trial will recruit 308 adults from five NHS Trusts in England, randomly assigning them to either Structured Psychological Support (SPS) or enhanced treatment as usual. The primary measure is social functioning—how well people manage work, relationships, and daily life—tracked over 12 months. Secondary outcomes include mental health, suicidal behaviour, and quality of life. If SPS proves effective and cost-effective, it could substantially expand the number of people with personality disorder who receive evidence-based treatment. Rather than requiring months of intensive therapy, a brief intervention could be delivered more widely in primary and secondary care, reaching patients who currently fall through the cracks. This would directly affect everyday life for thousands of people struggling with emotional distress and relationship difficulties, while also reducing pressure on specialist mental health services.
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RESEARCH QUESTION Among people with probable personality disorder, does Structured Psychological Support (SPS) compared to enhanced treatment as usual lead to improved health and social functioning over the following year? BACKGROUND The only treatments that are currently recommended by NICE for people with personality disorder are lengthy and highly intensive, which many people are unable or unwilling to use. Low intensity interventions may be more acceptable and inclusive, but evidence on their effectiveness is missing. AIMS AND OBJECTIVES To conduct a fully-powered, pragmatic, randomised controlled trial, to investigate the clinical effectiveness and cost-effectiveness of SPS for people with personality disorder and generate a contextualised analysis of intervention delivery and outcome generation. METHODS Multicentre, researcher-masked, RCT, including an integrated pilot phase, a parallel process evaluation and an economic evaluation. We will recruit people aged 18 or over with probable personality disorder from primary and secondary care mental health services in five NHS Trusts in England. We will exclude those who are unable or unwilling to provide written informed consent, have a co-existing organic or psychotic mental disorder, are already receiving psychological treatment for personality disorder, or are on a waiting list for it. Health technologies: SPS is an individual intervention delivered over six to 10 sessions, which uses techniques drawn from evidence-based high-intensity treatments. All those in the control arm of the trial will receive enhanced treatment as usual from mental health services, that ensures they have a current care plan and crisis plan. Study outcomes: Our primary outcome is social functioning measured over 12 months using the Work and Social Adjustment Scale (WSAS). Secondary outcomes are mental health, suicidal behaviour, health-related quality of life, patient-rated global improvement and satisfaction with care, six and 12 months after randomisation. We will concurrently assess resource use and costs from an NHS/PSS perspective using a modified version of the Adult Service Use Schedule. Sample size: Data from 215 participants (115 receiving SPS and 100 receiving enhanced TAU) are needed to have 90% power to detect a 3.8 point (SD = 9.5) minimum clinically important difference in WSAS at 12 months, using a 0.05 level of statistical significance. To take account of 30% loss to follow-up we will recruit 308 subjects. Process evaluation: Analysis of quantitative data on uptake of interventions and qualitative data from 40 clinicians and managers, 24 participants in the full trial and 20 participants and non-participants during the pilot phase of the trial. Analysis: ITT analysis using a general linear mixed model adjusted for baseline score, allocation group and study centre. TIMELINES FOR DELIVERY 32 months in total. Start date 01.04.22. Start of recruitment (pilot phase) - month 10. Recruitment in the full trial - month 14 to 17. Anticipated rate of recruitment = 38.5 participants per month. Follow up until month 29. Final report submitted month 32. DISSEMINATION Papers, reports, presentations, messaging though social media and a webinar aimed at users, providers and commissioners of mental health services. IMPACT Substantial increase in the number of people with personality disorder who receive effective evidence-based treatment.
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