20 Weeks DBT Group Skills Training Study

May 25, 2016 updated by: Shelley McMain, Centre for Addiction and Mental Health

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:

  1. frequency 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.

Study Overview

Status

Completed

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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
Self-report measures assessing self-harm and suicidal behaviour
baseline; 10 weeks; 20 weeks; 3 month follow up

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
Assesses for emergency and psychiatric hospitalizations
baseline; 10 weeks; 20 weeks; 3 month follow up
Barett Impulsiveness Scale (BIS-11; Patton et al., 1995)
Time Frame: Baseline; 10 weeks; 20 weeks; 3 months follow up
Self-report measure assessing for impulsive behaviour
Baseline; 10 weeks; 20 weeks; 3 months follow up
The State-trait Anger Expression Inventory (STAXI; Spielberger, Krasner & Solomon, 1988)
Time Frame: Baseline; 10 weeks; 20 weeks; 3 months Follow up
Self-report assessing for anger expressions
Baseline; 10 weeks; 20 weeks; 3 months Follow up
The Borderline Evaluation of Severity over time Scale (BEST; Phfolm & Bloom, 1997)
Time Frame: Baseline; 10 weeks; 20 weeks; 3 months Follow up
self-report measure assessing for severity of BPD symptoms
Baseline; 10 weeks; 20 weeks; 3 months Follow up
The Symptom Checklist 90 - Revised (SCL-90-R; Derogatis, 1983)
Time Frame: Baseline; 10 weeks; 20 weeks; 3 months Follow up
Self-report measure assessing for various psychiatric symptoms
Baseline; 10 weeks; 20 weeks; 3 months Follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shelley McMain, PhD., Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 31, 2010

First Submitted That Met QC Criteria

August 31, 2010

First Posted (Estimate)

September 1, 2010

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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