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
Protocol serial number	PB-PG-0906-10540
Sponsor	East London NHS Foundation Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

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

Primary study design	Interventional
Study design	Pilot randomised controlled pragmatic exploratory trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	DIALECT
Study objectives	Self-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) studied	Borderline personality disorder, self-harm
Intervention	DBT 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 type	Other
Primary outcome measure(s)	Days with self-harm during the 12-month period.
Key secondary outcome measure(s)	1. 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
Completion date	01/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. 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 criteria	Learning disabilities
Date of first enrolment	01/02/2008
Date of final enrolment	01/07/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Unit for Community and Social Psychiatry

London
E13 8SP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes