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Research Question
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STUDY SUMMARY tab on http://www.peps-trial.co.uk/ (from ISRCTN)
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Ethics Approval
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South East Wales Research Ethics Committee Panel C approved on 13/11/2009 (ref: 09/WSE03/48)
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Study Design
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Multicentre two-arm parallel group randomised controlled trial
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Design Type
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Sorry, not currently available
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Design Details
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Sorry, not currently available
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Health Condition(s) or Problem
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Personality disorder
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Participants Inclusion Criteria
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1. Living in the community
2. Presence of one or more personality disorder, as identified by the International Personality Disorder Examination
3. Aged 18 years or over, either sex
4. Proficiency in spoken English is necessary for trial participation due to the requirements of the interventions used
5. Capacity to provide valid informed consent
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Participants Exclusion Criteria
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Current exclusion criteria as of 23/06/2011:
1. Primary diagnosis of major functional psychosis
2. Insufficient degree of literacy, comprehension or attention to be able to engage in trial therapy and assessments
3. Currently engaged in psychological treatment for personality disorder, or likely to start such treatment during the trial period
4. Already enrolled in any other trial
Previous exclusion criteria:
1. Insufficient degree of literacy, comprehension or attention to be able to engage in trial therapy and assessments, as assessed by the Investigator or authorised designee in conjunction with the participants usual care team. This may be a result of psychosis, developmental disability, organic brain disorder, substance use, or any other disorder or disability.
2. Currently engaged in psychological treatment for personality disorder, or likely to start such treatment during the trial period
3. Already enrolled in any other trial
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Participant Sex
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Sorry, not currently available
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Participant Age Range
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Sorry, not currently available
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Participant Type
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Sorry, not currently available
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Target Sample Size
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340
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Date of First Enrolment
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Sorry, not currently available
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Date of Recruitment End
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Sorry, not currently available
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Date of End of Follow-up
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Sorry, not currently available
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Trial End Date
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Overall Trial Status
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Sorry, not currently available
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Countries of Recruitment
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United Kingdom
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Nation
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England
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Location
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Nottingham
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Interventions
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Psycho-education combined with problem solving (PEPS) therapy is a complex cognitive-behavioural intervention that integrates individual and group therapies. Psycho-education consists of up to 4 sessions of an individual collaborative dialogue designed to build a rapport with patients, inform them about their personality disorder, discuss its effects on interpersonal relationships and social functioning, and enhance motivation for therapy. Problem solving therapy is a 12-session group intervention designed to teach people strategies for solving interpersonal problems. Throughout the twelve week problem solving therapy group sessions, participants are offered additional, optional fortnightly individual support sessions with a group facilitator.
PEPS therapy will be compared with treatment as usual. (Added 23/06/2011; previous intervention for this point can be found below).
Follow-up assessments for all participants will be completed after the initial treatment phase (weeks 5 - 10), immediately after the second treatment phase (during weeks 24 - 26) and again four and twelve months after the end of the intervention.
Previous intervention:
PEPS therapy will be compared with a standardised form of 'treatment as usual' which will include an initial care planning session with a mental health worker, including plans for future contact with services and details of alternative sources of help and support, with a follow-up session after approximately 4 weeks and a further session approximately 4 months later with additional telephone support.
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Primary Outcome Measures
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Social functioning as measured by the Social Functioning Questionnaire (SFQ). This is an 8-item self-report scale, each item scored on a scale from 0 to 3. A reduction (i.e. an improvement) of 2 points or more on the SFQ at 1 year, post-treatment follow-up is the specified clinically significant change.
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Secondary Outcome Measures
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1. Receipt and cost of services post-therapy and at one year follow-up measured by the Client Service Receipt Inventory
2. Scheduled and unscheduled service use post-therapy and at one year follow-up measured by the Client Service Receipt Inventory and a service use record check.
3. Quality of life post-therapy and at one year follow-up measured by the EQ-5D
4. Referrer's ratings of functioning post-therapy and at one year follow-up measured by the Global Assessment of Functioning
5. Anxiety and depression post-therapy and at one year follow-up meaured by the Hospital Anxiety and Depression Scale
6. A rating of the client's self-assessment of problems post-therapy and at one year follow-up
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Website
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http://www.peps-trial.co.uk/
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