Treating PTSD in Patients With Borderline Personality Disorder

Phase 1

Completed

• Conditions: Stress Disorders, Post-Traumatic; Borderline Personality Disorder; Suicide; Self-Injurious Behavior
• Interventions: Behavioral: Dialectical Behavior Therapy; Behavioral: PTSD Protocol

• Registration Number: NCT01081314
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-03-03
• Study First Submitted QC: 2010-03-03
• Study First Posted: 2010-03-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-20
• Last Update Posted: 2015-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard DBT + PTSD Protocol	Dialectical Behavior Therapy	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.
Standard DBT + PTSD Protocol	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.
Standard DBT	Dialectical Behavior Therapy	Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).

Primary Outcome Measures

Name	Time	Method
PTSD Symptom Scale - Interview	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).
Suicide Attempt Self-Injury Interview	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Behavioral Research and Therapy Clinics, University of Washington; 🇺🇸 Seattle, Washington, United States