Psycho-Education with Problem Solving (PEPS) therapy for personality disorder
| ISRCTN | ISRCTN70660936 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70660936 |
| Secondary identifying numbers | HTA 08/53/06 |
- Submission date
- 30/11/2009
- Registration date
- 03/12/2009
- Last edited
- 16/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
STUDY SUMMARY tab on http://www.peps-trial.co.uk/
Contact information
Prof Mary McMurran
Scientific
Scientific
Institute of Mental Health
University of Nottingham
The Sir Colin Campbell Building
Triumph Road
Nottingham
NG7 2TU
United Kingdom
Study information
| Study design | Multicentre two-arm parallel group randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | INFORMATION SHEETS tab on http://www.peps-trial.co.uk/ |
| Scientific title | Psycho-Education with Problem Solving (PEPS) therapy for adults with personality disorder: a community-based randomised controlled trial |
| Study acronym | PEPS |
| Study objectives | The purpose of the trial is to evaluate the effectiveness of PEPS therapy compared with treatment as usual in improving social functioning in community based adults with personality disorder. Please note, as of 23/06/2011 various updates have been made to this trial and can be found under this date of update in the relevant fields below. |
| Ethics approval(s) | South East Wales Research Ethics Committee Panel C approved on 13/11/2009 (ref: 09/WSE03/48) |
| Health condition(s) or problem(s) studied | Personality disorder |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/08/2010 |
| Completion date | 31/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 340 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 01/08/2010 |
| Date of final enrolment | 31/01/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Mental Health
Nottingham
NG7 2TU
United Kingdom
NG7 2TU
United Kingdom
Sponsor information
Nottinghamshire Healthcare NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Duncan MacMillan House
Porchester Road
Mapperley
Nottingham
NG3 6AA
England
United Kingdom
| Website | http://www.nottinghamshirehealthcare.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/04ehjk122 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/08/2011 | Yes | No | |
| Results article | results | 01/07/2016 | Yes | No |
Editorial Notes
16/01/2018: internal review.
21/07/2016: Publication reference added.
