DBT for Chronically Self-harming Individuals With BPD: Evaluating the Clinical & Cost Effectiveness of a 6 mo. Treatment (FASTER-DBT)
Primary Purpose
Borderline Personality Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dialectical Behaviour Therapy-6 months
Dialectical Behaviour Therapy-12 months
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring BPD, DBT, Dialectical Behaviour Therapy, Borderline Personality Disorder, Suicide, Non-suicidal self injury, NSSI, Randomized Control trials, treatment
Eligibility Criteria
Inclusion Criteria:
- Meets DSM-IV criteria for Borderline Personality Disorder.
- Has had at least 2 self-harm episodes (either suicidal or non-suicidal) in the past 5 years, including at least 1 in the past 8 weeks.
- Proficient in English
- Provides informed consent to participate in the study.
- Absence of 8 or more standard weeks of DBT in the past year (individual and group therapy components).
- has had either Ontario Health Insurance Plan (OHIP) coverage or BC Medical Services Plan (MSP) health insurance for 1 year or more
- Absence of a pending criminal court case or charges.
- Has been a resident of Ontario or British Columbia for all of the past 12 months, at least.
- Lives in the Greater Toronto Area/Greater Vancouver Area
Exclusion Criteria:
- Meets the DSM-IV criteria for bipolar disorder I, dementia, or a psychotic disorder other than psychotic disorder NOS
- IQ less than 70
- Chronic or serious physical health problem requiring hospitalization within the next year (e.g., cancer)
- Plans to move to a province other than Ontario or BC in the next 2 years.
Sites / Locations
- Simon Fraser University
- Center for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dialectical Behaviour Therapy-6 months
Dialectical Behaviour Therapy-12 months
Arm Description
6 months of standard dialectical behaviour therapy treatment.
12 months of standard dialectical behaviour therapy treatment
Outcomes
Primary Outcome Measures
Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII)
Records details regarding the frequency, topography, intent, medical severity, social context, precipitating and concurrent events, and outcomes of each self-harm (suicidal and non-suicidal) behavior during a three-month target time period.
Secondary Outcome Measures
Changes in health care use as measured by the Treatment History Interview-2 (THI-2)
Records participants use of other treatment resources, e.g. number of Hospitalizations, Emergency Room Visits, Medications, Psychosocial Treatments
Change in general functioning as measured by the Euroqol-5D
Assesses health related quality of life
Change in BPD symptoms as measured by the Borderline Symptom List-23 (BSL-23)
Assesses presence of specific BPD symptoms
Change in general psychopathology and symptoms, as measures by the Symptom Checklist 90 Revised (SCL-90R)
Assesses general symptom distress
Change in anger as measured by the State-Trait Anger Expression Inventory-2 (STAXI-2)
Assesses a subject's experience and expression of anger
Change in depression as measured by the Beck Depression Inventory-II (BDI-II)
Assesses symptoms of depression
Changes to interpersonal functioning as measured by the Inventory of Interpersonal Problems-64 (IIP-64)
Assesses dysfunctional patterns in interpersonal interactions
Changes in the use of DBT coping skills, as measured by the Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)
Assesses the use of DBT skills
Full Information
NCT ID
NCT02387736
First Posted
February 20, 2015
Last Updated
January 6, 2021
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Simon Fraser University
1. Study Identification
Unique Protocol Identification Number
NCT02387736
Brief Title
DBT for Chronically Self-harming Individuals With BPD: Evaluating the Clinical & Cost Effectiveness of a 6 mo. Treatment
Acronym
FASTER-DBT
Official Title
Dialectical Behaviour Therapy for Chronically Self-harming Individuals With BPD: Evaluating the Clinical and Cost Effectiveness of a 6-month Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Simon Fraser University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Standard one-year dialectical behaviour therapy (DBT), which has four components, is an effective treatment for people with borderline personality disorder. However, such DBT programs are in short supply and costly, resulting in long wait lists. In practice, DBT is often reduced in length or intensity. This study will determine whether shorter DBT treatment is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two years. Rates of suicidal and self-harm behaviours, use of health care and general psychological functioning will be examined.
Detailed Description
Borderline personality disorder (BPD) is a serious and debilitating psychiatric condition characterized by instability in relationships, emotions, identity, and behaviour. Affecting 2-6% of the general population, BPD is associated with high rates of self-harm (both suicide attempts and non-suicidal self-injury), mortality by suicide, and consequent heavy use of public health resources, making it one of the most expensive psychiatric disorders to treat. Psychotherapy is recognized as the first-line treatment for BPD, of which dialectical behaviour therapy (DBT) has demonstrated the strongest empirical support. Although DBT is efficacious for self-harming individuals with BPD, and increasingly available over the past 10 years, demand for DBT exceeds existing resources.
Within the current climate of rising health care costs and limited resources, the length (12 month) and intensive nature (entailing multiple treatment components) of standard DBT are major barriers to its adoption. Subsequently, most DBT programs have lengthy wait lists. Inadequate accessibility of treatment is not specific to Canada; it is a global problem. In clinical practice, DBT is often abbreviated, or clinicians deliver only the components that they believe are most appropriate, despite an evidence base almost entirely consisting of studies of 1 year of DBT. There are no data on the optimal length of treatment.
Therefore, the primary aim of this proposal is to examine the efficacy of an abbreviated course of DBT (including all components of treatment) compared to the evidence-supported 12 months of DBT. Our principal question is: How do the clinical outcomes of 6 months of DBT (DBT-6) compare with the standard 12 months (DBT-12) for the treatment of chronically self-harming individuals with BPD? Assessments will be conducted at pretreatment and at 3-month intervals until 24 months (i.e., 3, 6, 9, 12, 15, 18, 21, and 24 months).
Hypotheses: (1) Patients in the DBT-6 arm will show reductions in the frequency of self-harm across the treatment phase and one-year post treatment follow-up phase no worse than those measured with patients in the DBT-12 arm. (2) Patients who present with high rates of self-harm and impulsive behaviours will have reductions in the frequency of self-harm behaviours that are no worse than those in the DBT-6 arm and the DBT-12 arm, over the course of both the treatment phase and the 1-year post treatment follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
BPD, DBT, Dialectical Behaviour Therapy, Borderline Personality Disorder, Suicide, Non-suicidal self injury, NSSI, Randomized Control trials, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dialectical Behaviour Therapy-6 months
Arm Type
Experimental
Arm Description
6 months of standard dialectical behaviour therapy treatment.
Arm Title
Dialectical Behaviour Therapy-12 months
Arm Type
Active Comparator
Arm Description
12 months of standard dialectical behaviour therapy treatment
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behaviour Therapy-6 months
Other Intervention Name(s)
DBT-6
Intervention Description
Modification of behaviours achieved with reframing thoughts and impulses
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behaviour Therapy-12 months
Other Intervention Name(s)
DBT-12
Intervention Description
Modification of behaviours achieved with reframing thoughts and impulses
Primary Outcome Measure Information:
Title
Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII)
Description
Records details regarding the frequency, topography, intent, medical severity, social context, precipitating and concurrent events, and outcomes of each self-harm (suicidal and non-suicidal) behavior during a three-month target time period.
Time Frame
Administered pre-treatment and every three months until 24 months
Secondary Outcome Measure Information:
Title
Changes in health care use as measured by the Treatment History Interview-2 (THI-2)
Description
Records participants use of other treatment resources, e.g. number of Hospitalizations, Emergency Room Visits, Medications, Psychosocial Treatments
Time Frame
Administered pre-treatment and every three months until 24 months
Title
Change in general functioning as measured by the Euroqol-5D
Description
Assesses health related quality of life
Time Frame
At pre-treatment and every three months until 24 months
Title
Change in BPD symptoms as measured by the Borderline Symptom List-23 (BSL-23)
Description
Assesses presence of specific BPD symptoms
Time Frame
At pre-treatment and every three months over 24 months
Title
Change in general psychopathology and symptoms, as measures by the Symptom Checklist 90 Revised (SCL-90R)
Description
Assesses general symptom distress
Time Frame
At pre-treatment and every three months over 24 months
Title
Change in anger as measured by the State-Trait Anger Expression Inventory-2 (STAXI-2)
Description
Assesses a subject's experience and expression of anger
Time Frame
At pre-treatment and every three months over 24 months
Title
Change in depression as measured by the Beck Depression Inventory-II (BDI-II)
Description
Assesses symptoms of depression
Time Frame
At pre-treatment and every three months over 24 months
Title
Changes to interpersonal functioning as measured by the Inventory of Interpersonal Problems-64 (IIP-64)
Description
Assesses dysfunctional patterns in interpersonal interactions
Time Frame
At pre-treatment and every three months over 24 months
Title
Changes in the use of DBT coping skills, as measured by the Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)
Description
Assesses the use of DBT skills
Time Frame
At pre-treatment and every three months over 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets DSM-IV criteria for Borderline Personality Disorder.
Has had at least 2 self-harm episodes (either suicidal or non-suicidal) in the past 5 years, including at least 1 in the past 8 weeks.
Proficient in English
Provides informed consent to participate in the study.
Absence of 8 or more standard weeks of DBT in the past year (individual and group therapy components).
has had either Ontario Health Insurance Plan (OHIP) coverage or BC Medical Services Plan (MSP) health insurance for 1 year or more
Absence of a pending criminal court case or charges.
Has been a resident of Ontario or British Columbia for all of the past 12 months, at least.
Lives in the Greater Toronto Area/Greater Vancouver Area
Exclusion Criteria:
Meets the DSM-IV criteria for bipolar disorder I, dementia, or a psychotic disorder other than psychotic disorder NOS
IQ less than 70
Chronic or serious physical health problem requiring hospitalization within the next year (e.g., cancer)
Plans to move to a province other than Ontario or BC in the next 2 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelley McMain, Ph.D
Organizational Affiliation
The Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simon Fraser University
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5A IS6
Country
Canada
Facility Name
Center for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
http://www.camh.ca/en/research
Description
The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.
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DBT for Chronically Self-harming Individuals With BPD: Evaluating the Clinical & Cost Effectiveness of a 6 mo. Treatment
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