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DBT for Chronically Self-harming Individuals With BPD: Evaluating the Clinical & Cost Effectiveness of a 6 mo. Treatment (FASTER-DBT)

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ClinicalTrials.gov Identifier: NCT02387736
Recruitment Status : Active, not recruiting
First Posted : March 13, 2015
Last Update Posted : January 7, 2021
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Simon Fraser University
Information provided by (Responsible Party):
Shelley McMain, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Behavioral: Dialectical Behaviour Therapy-6 months Behavioral: Dialectical Behaviour Therapy-12 months Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dialectical Behaviour Therapy for Chronically Self-harming Individuals With BPD: Evaluating the Clinical and Cost Effectiveness of a 6-month Treatment
Actual Study Start Date : February 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dialectical Behaviour Therapy-6 months
6 months of standard dialectical behaviour therapy treatment.
Behavioral: Dialectical Behaviour Therapy-6 months
Modification of behaviours achieved with reframing thoughts and impulses
Other Name: DBT-6

Active Comparator: Dialectical Behaviour Therapy-12 months
12 months of standard dialectical behaviour therapy treatment
Behavioral: Dialectical Behaviour Therapy-12 months
Modification of behaviours achieved with reframing thoughts and impulses
Other Name: DBT-12




Primary Outcome Measures :
  1. Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) [ Time Frame: Administered pre-treatment and every three months until 24 months ]
    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 :
  1. Changes in health care use as measured by the Treatment History Interview-2 (THI-2) [ Time Frame: Administered pre-treatment and every three months until 24 months ]
    Records participants use of other treatment resources, e.g. number of Hospitalizations, Emergency Room Visits, Medications, Psychosocial Treatments

  2. Change in general functioning as measured by the Euroqol-5D [ Time Frame: At pre-treatment and every three months until 24 months ]
    Assesses health related quality of life

  3. Change in BPD symptoms as measured by the Borderline Symptom List-23 (BSL-23) [ Time Frame: At pre-treatment and every three months over 24 months ]
    Assesses presence of specific BPD symptoms

  4. Change in general psychopathology and symptoms, as measures by the Symptom Checklist 90 Revised (SCL-90R) [ Time Frame: At pre-treatment and every three months over 24 months ]
    Assesses general symptom distress

  5. Change in anger as measured by the State-Trait Anger Expression Inventory-2 (STAXI-2) [ Time Frame: At pre-treatment and every three months over 24 months ]
    Assesses a subject's experience and expression of anger

  6. Change in depression as measured by the Beck Depression Inventory-II (BDI-II) [ Time Frame: At pre-treatment and every three months over 24 months ]
    Assesses symptoms of depression

  7. Changes to interpersonal functioning as measured by the Inventory of Interpersonal Problems-64 (IIP-64) [ Time Frame: At pre-treatment and every three months over 24 months ]
    Assesses dysfunctional patterns in interpersonal interactions

  8. Changes in the use of DBT coping skills, as measured by the Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL) [ Time Frame: At pre-treatment and every three months over 24 months ]
    Assesses the use of DBT skills



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387736


Locations
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Canada, British Columbia
Simon Fraser University
Burnaby, British Columbia, Canada, V5A IS6
Canada, Ontario
Center for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Simon Fraser University
Investigators
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Principal Investigator: Shelley McMain, Ph.D The Centre for Addiction and Mental Health
Additional Information:
Publications:
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders 2013; 5 ed. Washington, DC: American Psychiatric Association Press.
Comtois, K. A., Elwood, L., Holdcraft, L. C., Smith, W. R., Simpson, T. L. Effectiveness of dialectical behaviour therapy in a community mental health centre. Cognitive And Behavioral Practice 2007; 14(4):406-14.
Linehan, M.M. Cognitive Behavioural Treatment of Borderline Personality Disorder. New York: Guilford Press; 1993.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shelley McMain, Head, Borderline Personality Disorder Clinic, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02387736    
Other Study ID Numbers: 026/2014
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shelley McMain, Centre for Addiction and Mental Health:
BPD
DBT
Dialectical Behaviour Therapy
Borderline Personality Disorder
Suicide
Non-suicidal self injury
NSSI
Randomized Control trials
treatment
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders