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Completed

NCT Number: NCT01193205

20 Weeks DBT Group Skills Training Study

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skills Training

Behavioral

20 weeks of Dialectical Behaviour Therapy Skills Training

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Ontario Mental Health Foundation

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 1, 2010
Registry last updated
May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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