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Open Access Study protocol

Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: A pragmatic multi-site community-based randomised clinical trial

Mary McMurran1*, Mike J Crawford3, Joseph G Reilly4, Paul McCrone5, Paul Moran5, Hywel Williams2, Clive E Adams1, Conor Duggan1, Juan Delport6, Diane Whitham2 and Florence Day2

Author Affiliations

1 Institute of Mental Health, University of Nottingham, Sir Colin Campbell Building, Triumph Road, Nottingham NG7 2TU, UK

2 Clinical Trials Unit, Nottingham Health Science Partners, C Floor, South Block, Queen's Medical Centre, Nottingham NG7 2UH, UK

3 Centre for Mental Health, Imperial College London, 37 Claybrook Road, London W6 8LN, UK

4 Wolfson Research Institute, University of Durham, Queen's Campus, Stockton on Tees TS17 6BH, UK

5 King's College London (Institute of Psychiatry), King's College London, London SE5 8AF, UK

6 Psychological Therapies Centre, St Tydfil's Hospital, Merthyr Tydfil, CF47 0SJ, UK

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Trials 2011, 12:198  doi:10.1186/1745-6215-12-198

Published: 24 August 2011

Abstract

Background

Impairment in social functioning is a key component of personality disorder. Therefore psycho-education and problem solving (PEPS) therapy may benefit people with this disorder. Psycho-education aims to educate, build rapport, and motivate people for problem solving therapy. Problem solving therapy aims to help clients solve interpersonal problems positively and rationally, thereby improving social functioning and reducing distress. PEPS therapy has been evaluated with community adults with personality disorder in an exploratory trial. At the end of treatment, compared to a wait-list control group, those treated with PEPS therapy showed better social functioning, as measured by the Social Functioning Questionnaire (SFQ). A definitive evaluation is now being conducted to determine whether PEPS therapy is a clinically and cost-effective treatment for people with personality disorder

Methods

This is a pragmatic, two-arm, multi-centre, parallel, randomised controlled clinical trial. The target population is community-dwelling adults with one or more personality disorder, as identified by the International Personality Disorder Examination (IPDE). Inclusion criteria are: Living in the community (including residential or supported care settings); presence of one or more personality disorder; aged 18 or over; proficiency in spoken English; capacity to provide informed consent. Exclusion criteria are: Primary diagnosis of a functional psychosis; insufficient degree of literacy, comprehension or attention to be able to engage in trial therapy and assessments; currently engaged in a specific programme of psychological treatment for personality disorder or likely to start such treatment during the trial period; currently enrolled in any other trial. Suitable participants are randomly allocated to PEPS therapy plus treatment as usual (TAU) or TAU only. We aim to recruit 340 men and women. The primary outcome is social functioning as measured by the SFQ. A reduction (i.e., an improvement) of 2 points or more on the SFQ at follow-up 72 weeks post-randomisation is our pre-specified index of clinically significant change. Secondary outcomes include a reduction of unscheduled service usage and an increase in scheduled service usage; improved quality of life; and a reduction in mental distress.

Discussion

PEPS therapy has potential as an economical, accessible, and acceptable intervention for people with personality disorder. The results from this randomised controlled trial will tell us if PEPS therapy is effective and cost-effective. If so, then it will be a useful treatment for inclusion in a broader menu of treatment options for this group of service users.

Trial Registration

International Standard Randomised Controlled Trial Number - ISRCTN70660936