NCT02354183

Brief Summary

Research suggests that individuals with Borderline Personality Disorder (BPD) experience low motivation for change (Skodal, Buckley, \& Charles, 1983). Dialectical Behavior Therapy (DBT; Linehan, 1993) includes commitment strategies that are designed to improve motivation. No studies have examined the effectiveness of these strategies. The proposed study will evaluate the efficacy of a brief DBT intervention consisting of commitment strategies plus skills training for people who self-harm. Participants will be randomly assigned to either a single orientation session of (1) commitment strategies plus psychoeducation or (2) psychoeducation. Immediately following their orientation session, all participants will be enrolled in a 90 minute group skills training session. Primary outcomes include autonomous motivation and frequency of self harm behaviours. Assessments will be conducted at six time points: baseline, after the initial orientation session, after the skills training group session, and at one week, one month, and three month follow-up

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

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

First Submitted

Initial submission to the registry

December 10, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

December 10, 2014

Last Update Submit

February 9, 2017

Conditions

Keywords

Commitment strategiesMotivationDBT skillsSelf-harmBrief intervention

Outcome Measures

Primary Outcomes (1)

  • Change in Autonomous and Controlled Motivation

    Autonomous and controlled motivation will be assessed using the Autonomous and Controlled Motivation for Treatment Questionnaire (Zuroff et al., 2005).

    From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months)

Secondary Outcomes (1)

  • Change in Frequency and severity of self-harm behaviour

    From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months)

Study Arms (2)

Commitment

EXPERIMENTAL

A 1-hour orientation session consisting of DBT commitment strategies plus psychoeducation. Therapists will also use commitment strategies to discuss goals related to self-harm. The psychoeducation will consist of information about DBT's biosocial theory and about why people self-harm. All participants will complete a DBT skills training group after their orientation.

Behavioral: DBT Skills Training

Psychoeducation

ACTIVE COMPARATOR

A 1-hour orientation session consisting of psychoeducation only. The psychoeducation will consist of information about DBT's biosocial theory and about why people self-harm. All participants will complete a DBT skills training group after their orientation.

Behavioral: DBT Skills Training

Interventions

Based on Linehan's (1993) manualized DBT approach, the brief DBT skills training group covers will cover five skills: wise mind, TIP skills, distraction, mindfulness of the current emotion, and opposite to emotion action.

CommitmentPsychoeducation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has a valid health card issued by a Canadian province or Canadian student organization (ie: UHIP)
  • Has had at least 3 self-harm episodes (either suicidal or non-suicidal) in the past 5 years, including at least 1 in the past eight weeks
  • Is literate in English
  • Absence of 4 or more formal weeks of DBT in the past year (individual or group therapy components)
  • Indicates absence of knowledge of the DBT Skills
  • Is able to attend all sessions on scheduled study day

You may not qualify if:

  • \) Evidence of organic brain syndrome or mental retardation

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 (1)

  • 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.

Related Links

MeSH Terms

Conditions

Orientation, SpatialBehaviorSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavioral Symptoms

Study Officials

  • Michelle Leybman, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

December 10, 2014

First Posted

February 3, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 10, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations