|
ISRCTN
|
ISRCTN02634417
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Hope for chronically suicidal patient: evaluating the clinical and health services impact of dialectical behaviour therapy (DBT) in individuals with borderline personality disorder
|
|
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
|
N/A
|
|
Serial number at source
|
MCT-58343
|
|
Study hypothesis
|
To evaluate the clinical and cost effectiveness of dialectical behaviour therapy (DBT) for chronically suicidal patients with borderline personality disorder (BPD).
|
|
Lay summary
|
|
|
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
|
|
Countries of recruitment
|
Canada
|
|
Disease/condition/study domain
|
Borderline personality disorder (BPD)
|
|
Participants - 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)
|
|
Participants - 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
|
|
Anticipated start date
|
01/10/2002
|
|
Anticipated end date
|
30/09/2007
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
180
|
|
Interventions
|
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
|
|
Primary outcome measure(s)
|
Parasuicidal behaviour
|
|
Secondary outcome measure(s)
|
1. Psychiatric hospitalisation
2. Psychiatric symptoms
3. Anger
4. Treatment retention
5. Social functioning
|
|
Sources of funding
|
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-58343)
|
|
Trial website
|
|
|
Publications
|
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19755574
|
|
Contact name
|
Dr
Shelley Frances
McMain
|
|
Address
|
Centre for Addiction and Mental Health
33 Russell St.
|
|
City/town
|
Toronto
|
|
Zip/Postcode
|
M5S 2S1
|
|
Country
|
Canada
|
|
Tel
|
+1 416 535 8501 ext. 6852
|
|
Fax
|
+1 416 595 6399
|
|
Email
|
shelley_McMain@camh.net
|
|
Sponsor
|
The Centre for Addiction and Mental Health (Toronto) (Canada)
|
|
Address
|
33 Russell Street
|
|
City/town
|
Toronto
|
|
Zip/Postcode
|
M5S 2S1
|
|
Country
|
Canada
|
|
Sponsor website:
|
http://www.camh.net/
|
|
Date applied
|
16/11/2005
|
|
Last edited
|
21/09/2009
|
|
Date ISRCTN assigned
|
16/11/2005
|
