Condition category
Mental and Behavioural Disorders
Date applied
30/11/2009
Date assigned
03/12/2009
Last edited
21/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

STUDY SUMMARY tab on http://www.peps-trial.co.uk/

Trial website

http://www.peps-trial.co.uk/

Contact information

Type

Scientific

Primary contact

Prof Mary McMurran

ORCID ID

Contact details

Institute of Mental Health
University of Nottingham
The Sir Colin Campbell Building
Triumph Road
Nottingham
NG7 2TU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 08/53/06

Study information

Scientific title

Psycho-Education with Problem Solving (PEPS) therapy for adults with personality disorder: a community-based randomised controlled trial

Acronym

PEPS

Study hypothesis

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

South East Wales Research Ethics Committee Panel C approved on 13/11/2009 (ref: 09/WSE03/48)

Study design

Multicentre two-arm parallel group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

INFORMATION SHEETS tab on http://www.peps-trial.co.uk/

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2010

Overall trial end date

31/01/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

340

Participant 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

Recruitment start date

01/08/2010

Recruitment end date

31/01/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Mental Health
Nottingham
NG7 2TU
United Kingdom

Sponsor information

Organisation

Nottinghamshire Healthcare NHS Trust (UK)

Sponsor details

Duncan MacMillan House
Porchester Road
Mapperley
Nottingham
NG3 6AA
United Kingdom

Sponsor type

Government

Website

http://www.nottinghamshirehealthcare.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21864370
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/27431341

Publication citations

  1. Protocol

    McMurran M, Crawford MJ, Reilly JG, McCrone P, Moran P, Williams H, Adams CE, Duggan C, Delport J, Whitham D, Day F, Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: a pragmatic multi-site community-based randomised clinical trial., Trials, 2011, 12, 198, doi: 10.1186/1745-6215-12-198.

Additional files

Editorial Notes

21/07/2016: Publication reference added.