20 Weeks DBT Group Skills Training Study

This study has been completed.
Sponsor:
Collaborator:
Ontario Mental Health Foundation
Information provided by (Responsible Party):
Shelley McMain, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01193205
First received: August 31, 2010
Last updated: January 18, 2013
Last verified: October 2012
  Purpose

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:

  1. severity of suicidal and NSSI behaviours
  2. symptom distress
  3. impulsivity
  4. treatment retention
  5. skill acquisition and
  6. 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.


Condition Intervention Phase
Borderline Personality Disorder
Behavioral: Skills Training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of Dialectical Behaviour Skills Training for Suicidality in Borderline Personality Disorder

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Deliberate Self-harm Inventory (DSHI; Gratz, 2001) [ Time Frame: baseline; 10 weeks; 20 weeks; 3 month follow up ] [ Designated as safety issue: Yes ]
    Self-report measure assessing self-harm and suicidal behaviour


Secondary Outcome Measures:
  • Treatment History Interview (THI-2; Linehan & Heard, 1987) [ Time Frame: baseline; 10 weeks; 20 weeks; 3 month follow up ] [ Designated as safety issue: No ]
    Assesses for emergency and psychiatric hospitalizations

  • Barett Impulsiveness Scale (BIS-11; Patton et al., 1995) [ Time Frame: Baseline; 10 weeks; 20 weeks; 3 months follow up ] [ Designated as safety issue: No ]
    Self-report measure assessing for impulsive behaviour

  • The State-trait Anger Expression Inventory (STAXI; Spielberger, Krasner & Solomon, 1988) [ Time Frame: Baseline; 10 weeks; 20 weeks; 3 months Follow up ] [ Designated as safety issue: No ]
    Self-report assessing for anger expressions

  • The Borderline Evaluation of Severity over time Scale (BEST; Phfolm & Bloom, 1997) [ Time Frame: Baseline; 10 weeks; 20 weeks; 3 months Follow up ] [ Designated as safety issue: No ]
    self-report measure assessing for severity of BPD symptoms

  • The Symptom Checklist 90 - Revised (SCL-90-R; Derogatis, 1983) [ Time Frame: Baseline; 10 weeks; 20 weeks; 3 months Follow up ] [ Designated as safety issue: No ]
    Self-report measure assessing for various psychiatric symptoms


Enrollment: 84
Study Start Date: July 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Skills Training
20 weeks of Dialectical Behaviour Therapy Skills Training
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193205

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Mental Health Foundation
Investigators
Principal Investigator: Shelley McMain, PhD. Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Shelley McMain, Head, Borderline Personality Disorder Clinic, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01193205     History of Changes
Other Study ID Numbers: 050/2010
Study First Received: August 31, 2010
Last Updated: January 18, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
Borderline Personality Disorder
Skills Training
Dialectical Behavior Therapy
Suicidal and parasuicidal behavior

Additional relevant MeSH terms:
Borderline Personality Disorder
Personality Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014