Treating PTSD in Patients With Borderline Personality Disorder

November 20, 2015 updated by: Melanie Harned, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Behavioral Research and Therapy Clinics, University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
ACTIVE_COMPARATOR: Standard DBT
Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).
Behavioral: Dialectical Behavior Therapy
Standard Dialectical Behavior Therapy as described in the 2 DBT treatment manuals (Linehan, 1993a,b).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Symptom Scale - Interview
Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months
A structured clinical interview that measures both the presence and severity of the 17 DSM-IV PTSD symptoms related to specific trauma(s).
Pre-treatment, 4-, 8-, 12-, and 15-months
Suicide Attempt Self-Injury Interview
Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months
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.
Pre-treatment, 4-, 8-, 12-, and 15-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment History Interview
Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months
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.
Pre-treatment, 4-, 8-, 12-, and 15-months
Hamilton Rating Scale for Depression
Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months
An interview measuring symptoms of depression.
Pre-treatment, 4-, 8-, 12-, and 15-months
Dissociative Experiences Scale
Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months
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.
Pre-treatment, 4-, 8-, 12-, and 15-months
Suicidal Behaviors Questionnaire
Time Frame: Pre-treatment, 4-, 8-, 12-, and 15-months
A self-report measure of suicide ideation, suicide expectancies, and suicide threats and communications.
Pre-treatment, 4-, 8-, 12-, and 15-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Melanie S Harned, Ph.D., University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

March 3, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (ESTIMATE)

March 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 23, 2015

Last Update Submitted That Met QC Criteria

November 20, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36517-C
  • R34MH082143 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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