- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01193205
20 Weeks DBT Group Skills Training Study
Evaluating the Effectiveness of Dialectical Behaviour Skills Training for Suicidality in Borderline Personality Disorder
The aim of this study is to evaluate the effectiveness of a 20-week Dialectical Behaviour Therapy (DBT) skills training group for the treatment of chronic suicidal and non-suicidal self-injurious (NSSI) behaviours in individuals diagnosed with borderline personality disorder (BPD). Previous research has established the effectiveness of a one year comprehensive, combined individual and group DBT treatment. However, in practice, DBT is often offered in a skills only group format. This study will consist of a randomized, controlled trial designed to evaluate the effectiveness of DBT compared to a wait list control. 84 participants will be randomized to the 20-week DBT group or the wait-list and the following outcomes will be assessed:
- frequency of suicidal and NSSI behaviours
- symptom distress
- impulsivity
- treatment retention
- skill acquisition and
- social functioning
Assessments will occur at pre-treatment, 10 weeks, 20 weeks and 3 months post treatment. The following main hypotheses will be examined: (1) Patients in the DBT skills group condition will have superior outcomes to patients on the treatment as usual wait list control in areas targeted by the treatment: frequency of suicidal and NSSI behaviours, emergency room visits, psychiatric hospital admissions, impulsivity, and knowledge and use of behavioral skills, general symptoms. The group receiving DBT will have superior outcomes at post treatment and these outcomes will be maintained during the three month post-treatment follow-up.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of DSM-IV Borderline Personality Disorder
- 18-60 years of age
- have had two suicidal or non-suicidal self-injurious behaviours in the past five years with one occurring in the past ten weeks
- be literate in English
- provide informed consent to participate in the study.
Exclusion Criteria:
- not meet DSM-IV criteria for a psychotic disorder, bipolar disorder or, dementia
- not have evidence of an organic brain syndrome or mental retardation based on clinical interview
- not participated in DBT treatment during the past year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 20 weeks skills group
Participants receive 20 weeks of Dialectical Behaviour Therapy Skills training, covering 5 modules: mindfulness, interpersonal effectiveness, emotional regulation, distress tolerance, dialectics.
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20 weeks of Dialectical Behaviour Therapy Skills Training
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No Intervention: Waitlist
Participants on the waitlist condition will be assessed at baseline and symptoms monitored at 10 weeks, 20 weeks and 8 months following baseline assessment.
They will then be offered the active treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Deliberate Self-harm Inventory (DSHI; Gratz, 2001) and Lifetime Suicide Attempt Self-Injury interview (LSASI; formerly Lifetime Parasuicide Count, Linehan MM, Comtois KA, unpublished manuscript, 1996)
Time Frame: baseline; 10 weeks; 20 weeks; 3 month follow up
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Self-report measures assessing self-harm and suicidal behaviour
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baseline; 10 weeks; 20 weeks; 3 month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment History Interview (THI-2; Linehan & Heard, 1987)
Time Frame: baseline; 10 weeks; 20 weeks; 3 month follow up
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Assesses for emergency and psychiatric hospitalizations
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baseline; 10 weeks; 20 weeks; 3 month follow up
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Barett Impulsiveness Scale (BIS-11; Patton et al., 1995)
Time Frame: Baseline; 10 weeks; 20 weeks; 3 months follow up
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Self-report measure assessing for impulsive behaviour
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Baseline; 10 weeks; 20 weeks; 3 months follow up
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The State-trait Anger Expression Inventory (STAXI; Spielberger, Krasner & Solomon, 1988)
Time Frame: Baseline; 10 weeks; 20 weeks; 3 months Follow up
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Self-report assessing for anger expressions
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Baseline; 10 weeks; 20 weeks; 3 months Follow up
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The Borderline Evaluation of Severity over time Scale (BEST; Phfolm & Bloom, 1997)
Time Frame: Baseline; 10 weeks; 20 weeks; 3 months Follow up
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self-report measure assessing for severity of BPD symptoms
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Baseline; 10 weeks; 20 weeks; 3 months Follow up
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The Symptom Checklist 90 - Revised (SCL-90-R; Derogatis, 1983)
Time Frame: Baseline; 10 weeks; 20 weeks; 3 months Follow up
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Self-report measure assessing for various psychiatric symptoms
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Baseline; 10 weeks; 20 weeks; 3 months Follow up
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shelley McMain, PhD., Centre for Addiction and Mental Health
Publications and helpful links
General Publications
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Zeifman RJ, Boritz T, Barnhart R, Labrish C, McMain SF. The independent roles of mindfulness and distress tolerance in treatment outcomes in dialectical behavior therapy skills training. Personal Disord. 2020 May;11(3):181-190. doi: 10.1037/per0000368. Epub 2019 Oct 24.
- Krantz LH, McMain S, Kuo JR. The unique contribution of acceptance without judgment in predicting nonsuicidal self-injury after 20-weeks of dialectical behaviour therapy group skills training. Behav Res Ther. 2018 May;104:44-50. doi: 10.1016/j.brat.2018.02.006. Epub 2018 Mar 1.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 050/2010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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