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Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: A pragmatic multi-site community-based randomised clinical trial
Open accessAbstract
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.
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The Data Monitoring Committee of the PEPS trial noted higher rates of mental health-related adverse events (overdose, self-harm and suicide attempts) among those in the active arm of the intervention.
“the Data Monitoring Committee (DMC) of a publicly funded trial of a psychoeducation with problem-solving (PEPS) intervention for community-dwelling adults with personality disorder [1] noted higher rates of adverse events (AEs), specifically mental health-related adverse events (overdose, self-harm and suicide attempts), among those in the active arm of the intervention.”
From The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials (2014) · cites this paper as [1]
The Trial Steering Committee of the PEPS trial were unable to rule out the possibility that the intervention was instrumental in the excess of adverse events and issued an instruction to stop recruitment into the trial.
“The TSC were unable to rule out the possibility that the intervention was instrumental in the excess of AEs and so the TSC issued an instruction to stop recruitment into the trial.”
From The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials (2014) · cites this paper as [1]
In the PEPS trial, the Trial Steering Committee recommended that recruitment and treatment of participants should cease due to the excess number of adverse events relating to mental health in the active treatment arm, although the trial should continue to collect follow-up data on all of those who had already completed treatment.
“In the PEPS trial, the TSC recommended that recruitment and treatment of participants should cease due to the excess number of adverse events relating to mental health in the active treatment arm of the trial, although the trial should continue to collect follow-up data on all of those who had already completed treatment.”
From The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials (2014) · cites this paper as [1]
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Metadata
- Authors
- McMurran, M., Crawford, M. J., Reilly, J. G., McCrone, P., Moran, P., Williams, H., Adams, C. E., Duggan, C., Delport, J., Whitham, D., & Day, F.
- Affiliations
- University of Nottingham (GB)
- Centre for Mental Health (GB)
- Durham University (GB)
- King's College London (GB)
- Queen's Medical Centre (GB)
- Corresponding author
- McMurran, Mary
- ORCID
- Venue
- Trials
- Published
- 2011-08-24
- Volume
- 12
- Issue
- 1
- Pages
- 198-198
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC3171716
- OpenAlex
- W2123393914
- Cited by
- 14
- References
- 41
- Citations by year
- 2025: 1 · 2021: 2 · 2020: 4 · 2016: 1 · 2015: 1 · 2014: 1 · 2013: 2 · 2012: 1
- FWCI
- 1.38
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Durham Research Online (Durham University) (acceptedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Durham Research Online (Durham University) (submittedVersion, cc-by)
- Explore Bristol Research (submittedVersion)
- Funders
- National Institute for Health and Care Research (08/53/06)
- Health Technology Assessment Programme (08/53/06)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Personality Disorders and Psychopathology
- Social Sciences › Psychology › Clinical Psychology › Personality Traits and Psychology
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- psychoeducation, problem-solving therapy, personality disorders, social functioning, community-dwelling adults, cost-effectiveness, psychological distress, quality of life, service utilization, usual care, community mental health services, International Personality Disorder Examination, treatment acceptability, treatment accessibility, treatment demand
- MeSH terms
- Adolescent, Adult, Cost-Benefit Analysis, Female, United Kingdom, Humans, Male, Mental Health Services, Personality Disorders, Problem Solving, Psychiatric Status Rating Scales, Psychotherapy, Group, Quality of Life, Research Design, Social Behavior, Time Factors, Cognitive Behavioral Therapy, Single-Blind Method, Treatment Outcome, Health Care Costs, Quality-Adjusted Life Years, Young Adult
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