Borderline Personality DisorderNCT01635556
Evaluation of a Modified Dialectical Behavior Therapy Program
An observational study of Borderline Personality Disorder, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Dialectical Behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Jan 2016
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will be selected from the community.
Who may be able to join
- 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
Who cannot join
- Active psychosis
- Severe developmental delays, cognitive impairment or learning disabilities
- History of or current violent/aggressive behaviors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Modified Dialectical Behavior Therapy Program for Borderline Personality Disorder
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.
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Dialectical Behavior therapy
- Keywords
- borderline personality disorder, dialectical behavior therapy, psychological treatment
- 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.
Dialectical Behavior therapyBehavioural
Weekly psychotherapy of both individual and group sessions
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change - 12 months to 18 months
Secondary outcomes (4)
Borderline Symptom List 23
Measured: Baseline
Borderline Symptom List 23
Measured: Change - baseline to 6 months
Borderline Symptom List 23
Measured: Change - 6 months to 12 months
Borderline Symptom List 23
Measured: Chabge - 12 months to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Krysanski, PHD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635556
- Sponsor's protocol ID
- H2012:128
- Status last verified
- Nov 2014
- First submitted
- 23 May 2012
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Modified Dialectical Behavior Therapy Program for Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT01635556
- Acronym / sponsor ID
- H2012:128
- Conditions
- Borderline Personality Disorder
- Keywords
- borderline personality disorder, dialectical behavior therapy, psychological treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be selected from the community.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Active psychosis
- Severe developmental delays, cognitive impairment or learning disabilities
- History of or current violent/aggressive behaviors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavior therapyWeekly psychotherapy of both individual and group sessions | Behavioural | – |
Primary outcome
Quality of Life Enjoyment and Satisfaction Questionnaire
Time frame: Baseline
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
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
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
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.
4 secondary outcomes
Borderline Symptom List 23
Time frame: Baseline
Borderline Symptom List 23
Time frame: Change - baseline to 6 months
Borderline Symptom List 23
Time frame: Change - 6 months to 12 months
Borderline Symptom List 23
Time frame: Chabge - 12 months to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: No
Related trials for Borderline Personality Disorder
Recruiting
Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
Borderline Personality Disorder (BPD)
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MDMA in Borderline Personality Disorder
Borderline Personality Disorder
Active, not recruitingPhase 2
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
Borderline Personality Disorder
Recruiting
Predictors of Clinical Course and Treatment Response in DBT Programmes
Self Harm, Borderline Personality Disorder
Recruiting
Effectiveness of Enhanced Dialectical Behavior Therapy Skills Training Group for Borderline Personality Disorder
Borderline Personality Disorder (BPD), Dialectical Behavior Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Krysanski, PHD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder, run by University of Manitoba 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 3 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 8 May 2017. 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.
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?
Quality of Life Enjoyment and Satisfaction Questionnaire (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2017.