20 Weeks DBT Group Skills Training Study
Primary Purpose
Borderline Personality Disorder
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Skills Training
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder, Skills Training, Dialectical Behavior Therapy, Suicidal and parasuicidal behavior
Eligibility Criteria
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
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
20 weeks skills group
Waitlist
Arm Description
Participants receive 20 weeks of Dialectical Behaviour Therapy Skills training, covering 5 modules: mindfulness, interpersonal effectiveness, emotional regulation, distress tolerance, dialectics.
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.
Outcomes
Primary Outcome Measures
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and Lifetime Suicide Attempt Self-Injury interview (LSASI; formerly Lifetime Parasuicide Count, Linehan MM, Comtois KA, unpublished manuscript, 1996)
Self-report measures assessing self-harm and suicidal behaviour
Secondary Outcome Measures
Treatment History Interview (THI-2; Linehan & Heard, 1987)
Assesses for emergency and psychiatric hospitalizations
Barett Impulsiveness Scale (BIS-11; Patton et al., 1995)
Self-report measure assessing for impulsive behaviour
The State-trait Anger Expression Inventory (STAXI; Spielberger, Krasner & Solomon, 1988)
Self-report assessing for anger expressions
The Borderline Evaluation of Severity over time Scale (BEST; Phfolm & Bloom, 1997)
self-report measure assessing for severity of BPD symptoms
The Symptom Checklist 90 - Revised (SCL-90-R; Derogatis, 1983)
Self-report measure assessing for various psychiatric symptoms
Full Information
NCT ID
NCT01193205
First Posted
August 31, 2010
Last Updated
May 25, 2016
Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Mental Health Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01193205
Brief Title
20 Weeks DBT Group Skills Training Study
Official Title
Evaluating the Effectiveness of Dialectical Behaviour Skills Training for Suicidality in Borderline Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Mental Health Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The study will consist of a single-blind, two-arm randomized controlled trial designed to evaluate the effectiveness of DBT skills group offered as an adjunct to treatment as usual compared to a wait list control plus treatment as usual. The continuation of treatment as usual in both arms is permitted for two reasons. First, it would be unethical to assign suicidal patients to a wait list condition that prohibited involvement in ongoing treatment. Second, the proposed design enables us to address the question of the additive effect of the DBT skills group intervention. Subjects will be randomized to receive 20 weeks of DBT group skills training plus treatment as usual, or to a wait list control plus treatment as usual. Clinical effectiveness outcomes will be assessed at baseline, at 10 weeks, at 20 weeks and at 8 months follow-up. DBT skills training is a manualized intervention developed by Linehan (1993). Key skills from the modules described in Miller, Rathus, and Linehan (2006) will serve as the basis of the DBT skills group, delivered in a psychoeducational format over the course of weekly two-hour sessions. The skills group covers five modules: mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness, and dialectics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Borderline Personality Disorder, Skills Training, Dialectical Behavior Therapy, Suicidal and parasuicidal behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20 weeks skills group
Arm Type
Experimental
Arm Description
Participants receive 20 weeks of Dialectical Behaviour Therapy Skills training, covering 5 modules: mindfulness, interpersonal effectiveness, emotional regulation, distress tolerance, dialectics.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Skills Training
Intervention Description
20 weeks of Dialectical Behaviour Therapy Skills Training
Primary Outcome Measure Information:
Title
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)
Description
Self-report measures assessing self-harm and suicidal behaviour
Time Frame
baseline; 10 weeks; 20 weeks; 3 month follow up
Secondary Outcome Measure Information:
Title
Treatment History Interview (THI-2; Linehan & Heard, 1987)
Description
Assesses for emergency and psychiatric hospitalizations
Time Frame
baseline; 10 weeks; 20 weeks; 3 month follow up
Title
Barett Impulsiveness Scale (BIS-11; Patton et al., 1995)
Description
Self-report measure assessing for impulsive behaviour
Time Frame
Baseline; 10 weeks; 20 weeks; 3 months follow up
Title
The State-trait Anger Expression Inventory (STAXI; Spielberger, Krasner & Solomon, 1988)
Description
Self-report assessing for anger expressions
Time Frame
Baseline; 10 weeks; 20 weeks; 3 months Follow up
Title
The Borderline Evaluation of Severity over time Scale (BEST; Phfolm & Bloom, 1997)
Description
self-report measure assessing for severity of BPD symptoms
Time Frame
Baseline; 10 weeks; 20 weeks; 3 months Follow up
Title
The Symptom Checklist 90 - Revised (SCL-90-R; Derogatis, 1983)
Description
Self-report measure assessing for various psychiatric symptoms
Time Frame
Baseline; 10 weeks; 20 weeks; 3 months Follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelley McMain, PhD.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33884617
Citation
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(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
PubMed Identifier
31647267
Citation
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.
Results Reference
derived
PubMed Identifier
29529508
Citation
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.
Results Reference
derived
Links:
URL
http://www.camh.net/research
Description
Related Info
Learn more about this trial
20 Weeks DBT Group Skills Training Study
We'll reach out to this number within 24 hrs