Condition category
Mental and Behavioural Disorders
Date applied
30/07/2008
Date assigned
25/09/2008
Last edited
23/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stefan Priebe

ORCID ID

Contact details

Unit for Community and Social Psychiatry
Newham Centre for Mental Health
Cherry Tree Way
Glen Road
Plaistow
London
E13 8SP
United Kingdom
+44 (0)20 7540 4210
s.priebe@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-0906-10540

Study information

Scientific title

Acronym

DIALECT

Study hypothesis

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

The Camden and Islington Community Local Research Ethics Committee, 18/02/2008, ref: 07/H0722/98

Study design

Pilot randomised controlled pragmatic exploratory trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Days with self-harm during the 12-month period.

Secondary outcome measures

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

Overall trial start date

01/02/2008

Overall trial end date

01/07/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

Learning disabilities

Recruitment start date

01/02/2008

Recruitment end date

01/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

East London NHS Foundation Trust (UK)

Sponsor details

Trust Headquarters
EastONE
22 Commercial Street
London
E1 6LP
United Kingdom
+44 (0)20 7655 4000
webadmin@eastlondon.nhs.uk

Sponsor type

Government

Website

http://www.eastlondon.nhs.uk/

Funders

Funder type

Government

Funder name

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

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22964561

Publication citations

  1. Results

    Priebe S, Bhatti N, Barnicot K, Bremner S, Gaglia A, Katsakou C, Molosankwe I, McCrone P, Zinkler M, Effectiveness and cost-effectiveness of dialectical behaviour therapy for self-harming patients with personality disorder: a pragmatic randomised controlled trial., Psychother Psychosom, 2012, 81, 6, 356-365, doi: 10.1159/000338897.

Additional files

Editorial Notes