20 Weeks DBT Group Skills Training Study

Borderline Personality Disorder Clinical Trial

Official title:

Evaluating the Effectiveness of Dialectical Behaviour Skills Training for Suicidality in Borderline Personality Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193205
• Other study ID #: 050/2010
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2010
• Last updated: May 25, 2016
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2016
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Behavioral:
• Skills Training
20 weeks of Dialectical Behaviour Therapy Skills Training

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Ontario Mental Health Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline; 10 weeks; 20 weeks; 3 month follow up	Yes
Secondary	Treatment History Interview (THI-2; Linehan & Heard, 1987)	Assesses for emergency and psychiatric hospitalizations	baseline; 10 weeks; 20 weeks; 3 month follow up	No
Secondary	Barett Impulsiveness Scale (BIS-11; Patton et al., 1995)	Self-report measure assessing for impulsive behaviour	Baseline; 10 weeks; 20 weeks; 3 months follow up	No
Secondary	The State-trait Anger Expression Inventory (STAXI; Spielberger, Krasner & Solomon, 1988)	Self-report assessing for anger expressions	Baseline; 10 weeks; 20 weeks; 3 months Follow up	No
Secondary	The Borderline Evaluation of Severity over time Scale (BEST; Phfolm & Bloom, 1997)	self-report measure assessing for severity of BPD symptoms	Baseline; 10 weeks; 20 weeks; 3 months Follow up	No
Secondary	The Symptom Checklist 90 - Revised (SCL-90-R; Derogatis, 1983)	Self-report measure assessing for various psychiatric symptoms	Baseline; 10 weeks; 20 weeks; 3 months Follow up	No

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