NCT01193205

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:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

2.4 years

First QC Date

August 31, 2010

Last Update Submit

May 25, 2016

Conditions

Keywords

Borderline Personality DisorderSkills TrainingDialectical Behavior TherapySuicidal and parasuicidal behavior

Outcome Measures

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)

    Self-report measures assessing self-harm and suicidal behaviour

    baseline; 10 weeks; 20 weeks; 3 month follow up

Secondary Outcomes (5)

  • Treatment History Interview (THI-2; Linehan & Heard, 1987)

    baseline; 10 weeks; 20 weeks; 3 month follow up

  • Barett Impulsiveness Scale (BIS-11; Patton et al., 1995)

    Baseline; 10 weeks; 20 weeks; 3 months follow up

  • The State-trait Anger Expression Inventory (STAXI; Spielberger, Krasner & Solomon, 1988)

    Baseline; 10 weeks; 20 weeks; 3 months Follow up

  • The Borderline Evaluation of Severity over time Scale (BEST; Phfolm & Bloom, 1997)

    Baseline; 10 weeks; 20 weeks; 3 months Follow up

  • The Symptom Checklist 90 - Revised (SCL-90-R; Derogatis, 1983)

    Baseline; 10 weeks; 20 weeks; 3 months Follow up

Study Arms (2)

20 weeks skills group

EXPERIMENTAL

Participants receive 20 weeks of Dialectical Behaviour Therapy Skills training, covering 5 modules: mindfulness, interpersonal effectiveness, emotional regulation, distress tolerance, dialectics.

Behavioral: Skills Training

Waitlist

NO INTERVENTION

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.

Interventions

Skills TrainingBEHAVIORAL

20 weeks of Dialectical Behaviour Therapy Skills Training

20 weeks skills group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of DSM-IV Borderline Personality Disorder
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Shelley McMain, PhD.

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Borderline Personality Disorder Clinic

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 1, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 27, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations