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Borderline Personality DisorderPhase 1NCT01193205

20 Weeks DBT Group Skills Training Study

A Phase 1 study testing Skills Training in people with Borderline Personality Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Borderline Personality Disorder
What is being tested?
Skills Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteCanada
Study dates
Jul 2010to Dec 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5S 2S1

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Skills Training
Keywords
Borderline Personality Disorder, Skills Training, Dialectical Behavior Therapy, Suicidal and parasuicidal behavior
Medical subject headings
Borderline Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skills TrainingBehavioural

    20 weeks of Dialectical Behaviour Therapy Skills Training

Study groups in NCT01193205
Study groupRoleWhat they receive
20 weeks skills groupExperimentalParticipants receive 20 weeks of Dialectical Behaviour Therapy Skills training, covering 5 modules: mindfulness, interpersonal effectiveness, emotional regulation, distress tolerance, dialectics.
Receives: Behavioral: Skills Training
WaitlistNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (5)

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

    Assesses for emergency and psychiatric hospitalizations

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

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

    Self-report measure assessing for impulsive behaviour

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

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

    Self-report assessing for anger expressions

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

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

    self-report measure assessing for severity of BPD symptoms

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

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

    Self-report measure assessing for various psychiatric symptoms

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01193205
Sponsor's protocol ID
050/2010
Status last verified
May 2016
First submitted
31 Aug 2010
Last updated
27 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33884617

  • 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.

    PubMed 31647267

  • 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.

    PubMed 29529508

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Skills Training in people with Borderline Personality Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01193205, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.

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