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Treating PTSD in Patients With Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melanie Harned, University of Washington
ClinicalTrials.gov Identifier:
NCT01081314
First received: March 3, 2010
Last updated: June 17, 2013
Last verified: June 2013

March 3, 2010
June 17, 2013
August 2009
May 2013   (final data collection date for primary outcome measure)
  • PTSD Symptom Scale - Interview [ Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months ] [ Designated as safety issue: No ]
    A structured clinical interview that measures both the presence and severity of the 17 DSM-IV PTSD symptoms related to specific trauma(s).
  • Suicide Attempt Self-Injury Interview [ Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months ] [ Designated as safety issue: Yes ]
    A structured clinical interview measuring the topography, intent, medical severity, social context, precipitating and concurrent events, and outcomes of self-injurious and suicidal behavior during a target time period. Each episode is assessed separately and each act is also coded by the assessor (based on all information) as to whether or not it is a suicide attempt.
Same as current
Complete list of historical versions of study NCT01081314 on ClinicalTrials.gov Archive Site
  • Treatment History Interview [ Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months ] [ Designated as safety issue: No ]
    A structured interview that uses a time-line follow-back method of assessment to describe the participant's involvement with various psychological and medical treatments (e.g., professional psychotherapy, psychiatric hospitalization, physician visits) as well as medications prescribed.
  • Hamilton Rating Scale for Depression [ Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months ] [ Designated as safety issue: No ]
    An interview measuring symptoms of depression.
  • Dissociative Experiences Scale [ Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months ] [ Designated as safety issue: No ]
    A 28-item self-report measure that quantifies the frequency and intensity of a wide range of experiences that are indicative of absorption, dissociation, derealization, amnesia, and depersonalization.
  • Suicidal Behaviors Questionnaire [ Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months ] [ Designated as safety issue: No ]
    A self-report measure of suicide ideation, suicide expectancies, and suicide threats and communications.
Same as current
Not Provided
Not Provided
 
Treating PTSD in Patients With Borderline Personality Disorder
Treating PTSD in Patients With Borderline Personality Disorder

Individuals with borderline personality disorder (BPD) are the quintessential multi-problem patients, often presenting to treatment with numerous dysfunctional behaviors and comorbid diagnoses. Dialectical Behavior Therapy (DBT) is a comprehensive, cognitive-behavioral treatment for BPD that has been shown effective in reducing the primary problems it is designed to treat; namely, the frequency and severity of self-injurious and suicidal behavior, maintenance in treatment, and severe problems in living. However, the DBT treatment manual does not currently include a protocol specifying when or how to treat posttraumatic stress disorder (PTSD), a comorbid diagnosis that is prevalent in BPD patients and may maintain or exacerbate BPD criterion behaviors. Similarly, many of the existing treatment outcome studies for PTSD have excluded suicidal, substance abusing, and multiply diagnosed patients, thereby making it difficult to determine the generalizability of these approaches to individuals with BPD. The research proposed here is focused on the development of a protocol based on Prolonged Exposure therapy to treat PTSD in BPD patients that can be integrated into standard DBT, as well as the initial evaluation of this protocol's feasibility, acceptability, and efficacy. The treatment development and pilot testing process will occur in two phases, including measure development and standardization of the treatment protocol via clinical pre-testing (Phase 1); and pilot and feasibility testing of the intervention via a randomized controlled trial (RCT) comparing standard DBT + PTSD Protocol to standard DBT Only (Phase 2). Information gathered during the pilot RCT will be used to inform the design and conduct of a subsequent full-scale RCT. This research has the potential to significantly expand and improve upon the most empirically supported treatment currently available for BPD, while also demonstrating that exposure treatments for PTSD can be implemented safely and effectively in a BPD population.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Borderline Personality Disorder
  • Suicide
  • Self-Injurious Behavior
  • Behavioral: Dialectical Behavior Therapy
    Standard Dialectical Behavior Therapy as described in the 2 DBT treatment manuals (Linehan, 1993a,b).
  • Behavioral: PTSD Protocol
    A modified version of Prolonged Exposure therapy for PTSD
  • Experimental: Standard DBT + PTSD Protocol
    Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team) plus a modified version of Prolonged Exposure therapy for PTSD.
    Interventions:
    • Behavioral: Dialectical Behavior Therapy
    • Behavioral: PTSD Protocol
  • Active Comparator: Standard DBT
    Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).
    Intervention: Behavioral: Dialectical Behavior Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female
  • Age 18-60
  • Meet criteria for borderline personality disorder
  • Meet criteria for post-traumatic stress disorder
  • Can clearly remember at least some part of the traumatic event(s)
  • Recent and recurrent self-injurious behavior
  • Lives within commuting distance of University of Washington, Seattle campus
  • Consents to all research protocols

Exclusion Criteria:

  • Male
  • Court ordered to treatment
  • Diagnosis of psychotic disorder, bipolar disorder, or seizure disorder requiring medication
  • Less than 18 years of age or older than 60 years of age
  • Problems which by their presence or severity preclude ability to attend or understand treatment and/or requires priority treatment
  • Familial or domestic relationship with a current study participant
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01081314
36517-C, R34MH082143
Yes
Melanie Harned, University of Washington
University of Washington
National Institute of Mental Health (NIMH)
Principal Investigator: Melanie S Harned, Ph.D. University of Washington
University of Washington
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP