NCT01635556

Brief Summary

The goal of this pilot project is to offer outpatient Dialectical Behavior Therapy (DBT) treatment as described in Linehan's text (1993), which is considered an effective treatment of borderline personality disorder. This treatment consists of weekly individual psychotherapy, weekly group skills training, 24 hour telephone consultation, and weekly team consultation meetings for therapists. The investigators program is able to offer all of these components except the 24 hour phone consultation (which has been modified due to employment/union guidelines of interdisciplinary staff working within the investigators health care system). This project intends to offer the treatment for a period of 6 months. As such, this proposed research project seeks to assess the feasibility of implementing an outpatient DBT program within a public health care setting in Canada. This study also aims to evaluate this DBT program for clinical effectiveness in its modified format. Specifically, the investigators will examine relevant outcomes related to patient functioning (e.g., depression, self-harm and suicidal behaviors, and admissions to hospital/ER visits) and improvement (e.g., improved quality of life, meeting work/employment goals) pre and post completion of this 6 month treatment program. The investigators hypotheses are that each patient will show improvement in all outcome variables (e.g., improved mood and quality of life, decreased self-harm, decreased ER visits and hospitalization visits, etc). The investigators also hypothesize that the investigators modified program will produce comparable results to those from studies of standard outpatient DBT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

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

May 23, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 8, 2017

Status Verified

November 1, 2014

Enrollment Period

3.3 years

First QC Date

May 23, 2012

Last Update Submit

May 3, 2017

Conditions

Keywords

borderline personality disorderdialectical behavior therapypsychological treatment

Outcome Measures

Primary Outcomes (4)

  • Quality of Life Enjoyment and Satisfaction Questionnaire

    This measure assesses the degree of enjoyment and satisfaction experienced during the past week in several areas: physical health, feelings, work, household duties, school, leisure time, and social relationships.

    Baseline

  • Quality of Life Enjoyment and Satisfaction Questionnaire

    This measure assesses the degree of enjoyment and satisfaction experienced during the past week in several areas: physical health, feelings, work, household duties, school, leisure time, and social relationships.

    Change - baseline to 6 months

  • Quality of Life Enjoyment and Satisfaction Questionnaire

    This measure assesses the degree of enjoyment and satisfaction experienced during the past week in several areas: physical health, feelings, work, household duties, school, leisure time, and social relationships.

    Change - 6 months to 12 months

  • Quality of Life Enjoyment and Satisfaction Questionnaire

    This measure assesses the degree of enjoyment and satisfaction experienced during the past week in several areas: physical health, feelings, work, household duties, school, leisure time, and social relationships.

    Change - 12 months to 18 months

Secondary Outcomes (4)

  • Borderline Symptom List 23

    Baseline

  • Borderline Symptom List 23

    Change - baseline to 6 months

  • Borderline Symptom List 23

    Change - 6 months to 12 months

  • Borderline Symptom List 23

    Chabge - 12 months to 18 months

Interventions

Weekly psychotherapy of both individual and group sessions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants will be selected from the community.

You may qualify if:

  • Diagnosis of Borderline Personality Disorder
  • Chronic suicidal ideation or parasuicidal acts, or other self-destructive, impulsive behaviors
  • Must be enrolled in dialectical behavior therapy program

You may not qualify if:

  • Active psychosis
  • Severe developmental delays, cognitive impairment or learning disabilities
  • History of or current violent/aggressive behaviors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria General Hospital

Winnipeg, Manitoba, R3T 2E8, Canada

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Valerie Krysanski, PHD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

July 9, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 8, 2017

Record last verified: 2014-11

Data Sharing

IPD Sharing
Will not share

Locations