Evaluation of a Modified Dialectical Behavior Therapy Program

This study is currently recruiting participants.
Verified January 2014 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01635556
First received: May 23, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Borderline Personality Disorder
Behavioral: Dialectical Behavior therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Modified Dialectical Behavior Therapy Program for Borderline Personality Disorder

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: Change - baseline to 6 months ] [ Designated as safety issue: No ]
    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.

  • Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: Change - 6 months to 12 months ] [ Designated as safety issue: No ]
    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.

  • Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: Change - 12 months to 18 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Borderline Symptom List 23 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Borderline Symptom List 23 [ Time Frame: Change - baseline to 6 months ] [ Designated as safety issue: No ]
  • Borderline Symptom List 23 [ Time Frame: Change - 6 months to 12 months ] [ Designated as safety issue: No ]
  • Borderline Symptom List 23 [ Time Frame: Chabge - 12 months to 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Dialectical Behavior therapy
    Weekly psychotherapy of both individual and group sessions
Detailed Description:

Standard DBT includes four modes of intervention: weekly individual psychotherapy; weekly skills group; 24 hour phone consultation to the patient; and consultation team meetings. The skills group is focused on teaching skills (mindfulness, emotional regulation, distress tolerance, and interpersonal effectiveness), and facilitating the replacement of maladaptive behaviors with adaptive behaviors (Neasciu, Rizvi, & Linehan, 2010). Individual therapy sessions focus on reducing target problem behaviors (e.g., life threatening behavior, therapy interfering behavior, quality of life interfering behaviors). Phone consultation is to aid the client in generalizing skill use to their every day life. The consultation team meetings are for the therapists, to provide support, and to aid therapists in staying adherent to a DBT frame of treatment.

This project will be utilizing a convenience sample. Patients are referred to the program by their psychiatrist/family doctor. They are assessed by a Clinical Psychologist to determine if they meet criteria for a diagnosis of Borderline Personality Disorder via clinical interview and a semi-structured diagnostic interview. They must also meet the inclusion/exclusion criteria for participation in the program, which are as follows:

Inclusion Criteria

  • 18 years or older
  • Borderline personality disorder diagnosis
  • Chronic suicidal ideation or parasuicidal acts, or other self-destructive, impulsive behaviors
  • Must be willing to sign DBT contract and commit to 6-month duration of treatment of both individual therapy and skills training group.

Exclusion Criteria

  • Active psychosis
  • Severe developmental delays, cognitive impairment or learning disabilities
  • No violent behaviors will be tolerated. Patients with a history of dangerous or aggressive behaviors towards others, history of medical harm to previous therapists may not be considered.

Following this, they must agree to participate in the program and to the program requirements (weekly individual therapy, skills group, etc). Once this has occurred, they will be approached by a research assistant to discuss with them their voluntary participation in this research study. Once consent is provided, the patient will complete several baseline measures. These same measures will be completed at post treatment (6 months) and then again at 12 months and 18 months for follow-up. Each patient will also complete a weekly diary card, which asks them to record several aspects of daily functioning, as well as self-harm urges and behaviors, and use of skills taught in DBT.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The participants will be selected from the community.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active psychosis
  • Severe developmental delays, cognitive impairment or learning disabilities
  • History of or current violent/aggressive behaviors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01635556

Contacts
Contact: Valerie Krysanski, PHD 2044773119 vkrysanski@vgh.mb.ca

Locations
Canada, Manitoba
Victoria General Hospital Recruiting
Winnipeg, Manitoba, Canada, R3T 2E8
Contact: Valerie Krysanski, PHD    2044773119    vkrysanski@vgh.mb.ca   
Principal Investigator: Valerie Krysanski, PHD         
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Valerie Krysanski, PHD University of Manitoba
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01635556     History of Changes
Other Study ID Numbers: H2012:128
Study First Received: May 23, 2012
Last Updated: January 7, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
borderline personality disorder
dialectical behavior therapy
psychological treatment

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014