Dialectical behaviour therapy in patients with borderline personality disorder who self-harm: a pragmatic exploratory trial

ISRCTN ISRCTN54233644
DOI https://doi.org/10.1186/ISRCTN54233644
Secondary identifying numbers PB-PG-0906-10540
Submission date
30/07/2008
Registration date
25/09/2008
Last edited
23/07/2014
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

Not provided at time of registration

Contact information

Prof Stefan Priebe
Scientific

Unit for Community and Social Psychiatry
Newham Centre for Mental Health
Cherry Tree Way, Glen Road
Plaistow
London
E13 8SP
United Kingdom

Phone +44 (0)20 7540 4210
Email s.priebe@qmul.ac.uk

Study information

Study designPilot randomised controlled pragmatic exploratory trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymDIALECT
Study objectivesSelf-harming patients receiving a one-year course of dialectical behaviour therapy (DBT) will self-harm less over the 12 months than patients receiving one year of treatment as usual.
Ethics approval(s)The Camden and Islington Community Local Research Ethics Committee, 18/02/2008, ref: 07/H0722/98
Health condition(s) or problem(s) studiedBorderline personality disorder, self-harm
InterventionDBT and care co-ordination versus waiting list control group with standard NHS care, over 12 months. DBT consists of 3 hours of therapy a week: this comprises 1 hour of individual therapy and 2 hours of group skills classes.
Intervention typeOther
Primary outcome measureDays with self-harm during the 12-month period.
Secondary outcome measures1. Pre-post changes in self-harming during the 12-month period
2. Number of accident and emergency (A&E) attendances during the 12-month period
3. Inpatient admissions during the 12-month period
4. Use of other services in primary and secondary care during the 12-month period
5. Service costs during the 12-month period
6. Use of medication during the 12-month period
7. Pre-post changes in self-rated and observer-rated symptom level and quality of life at the end of the 12 month period
8. Quality of the therapeutic relationship at the end of the 12-month period
9. Treatment satisfaction at the end of the 12-month period
Overall study start date01/02/2008
Completion date01/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit16 Years
SexBoth
Target number of participants60
Key inclusion criteria1. Frequent self-harm (more than 5 days with self-harm over 12 months)
2. Aged 16 years and older, either sex
3. Sufficient command of English
4. At least one personality disorder
Key exclusion criteriaLearning disabilities
Date of first enrolment01/02/2008
Date of final enrolment01/07/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Unit for Community and Social Psychiatry
London
E13 8SP
United Kingdom

Sponsor information

East London NHS Foundation Trust (UK)
Hospital/treatment centre

Trust Headquarters
EastONE
22 Commercial Street
London
E1 6LP
England
United Kingdom

Phone +44 (0)20 7655 4000
Email webadmin@eastlondon.nhs.uk
Website http://www.eastlondon.nhs.uk/
ROR logo "ROR" https://ror.org/01q0vs094

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2012 Yes No