20 Weeks DBT Group Skills Training Study

NCT ID: NCT01193205

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Skills Training

Intervention Type BEHAVIORAL

20 weeks of Dialectical Behaviour Therapy Skills Training

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Skills Training

20 weeks of Dialectical Behaviour Therapy Skills Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Mental Health Foundation

OTHER_GOV

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Shelley McMain

Head, Borderline Personality Disorder Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shelley McMain, PhD.

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 33884617 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31647267 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29529508 (View on PubMed)

Related Links

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Other Identifiers

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050/2010

Identifier Type: -

Identifier Source: org_study_id

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