Condition category
Mental and Behavioural Disorders
Date applied
16/11/2005
Date assigned
16/11/2005
Last edited
21/09/2009
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

Dr Shelley Frances McMain

ORCID ID

Contact details

Centre for Addiction and Mental Health
33 Russell St.
Toronto
M5S 2S1
Canada
+1 416 535 8501 ext. 6852
shelley_McMain@camh.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-58343

Study information

Scientific title

Evaluating the clinical and health services impact of dialectical behaviour therapy (DBT) in individuals with borderline personality disorder: a randomised controlled trial

Acronym

Study hypothesis

To evaluate the clinical and cost effectiveness of dialectical behaviour therapy (DBT) for chronically suicidal patients with borderline personality disorder (BPD).

Ethics approval

Research Ethics Board of Centre for Addiction and Mental Health, University of Toronto approved on 28th October 2002

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Borderline personality disorder (BPD)

Intervention

1. Dialectical behaviour therapy (Linehan, 1993)
2. General Psychiatric Management based on the American Psychiatric Association (APA) practice guidelines

Trial details received: 12 Sept 2005

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Parasuicidal behaviour

Secondary outcome measures

1. Psychiatric hospitalisation
2. Psychiatric symptoms
3. Anger
4. Treatment retention
5. Social functioning

Overall trial start date

01/10/2002

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for BPD
2. Be between 18 - 60 years of age, either sex
3. Have had two Para-suicide episodes in the past 5 years with one occurring in the past 3 months
4. Have had OHIP insurance coverage for 1 year or more
5. Be literate in English
6. Provide informed consent to participate in study
7. Agree to be compliant with prescribed psychotropic medication(s)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Current active substance dependence disorder
2. Psychotic disorder, bipolar or dementia
3. Evidence of an organic brain syndrome or mental retardation
4. Chronic or serious physical health problem that may require hospitalisation with the next year
5. Medical condition that would preclude the psychiatric medication regimen
6. Currently engaged in DBT or in GPM at St Michael's Hospital

Recruitment start date

01/10/2002

Recruitment end date

30/09/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Centre for Addiction and Mental Health
Toronto
M5S 2S1
Canada

Sponsor information

Organisation

The Centre for Addiction and Mental Health (Toronto) (Canada)

Sponsor details

33 Russell Street
Toronto
M5S 2S1
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.camh.net/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-58343)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19755574

Publication citations

  1. Results

    McMain SF, Links PS, Gnam WH, Guimond T, Cardish RJ, Korman L, Streiner DL, A randomized trial of dialectical behavior therapy versus general psychiatric management for borderline personality disorder., Am J Psychiatry, 2009, 166, 12, 1365-1374, doi: 10.1176/appi.ajp.2009.09010039.

Additional files

Editorial Notes