Treating PTSD in Patients With Borderline Personality Disorder

Suicide Clinical Trial

Official title:

Treating PTSD in Patients With Borderline Personality Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081314
• Other study ID #: 36517-C
• Secondary ID: R34MH082143
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 3, 2010
• Last updated: November 20, 2015
• Start date: August 2009
• Est. completion date: May 2013

Study information

• Verified date: November 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Personality Disorders
• Self-Injurious Behavior
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Suicide

Intervention

Behavioral:
• Dialectical Behavior Therapy
Standard Dialectical Behavior Therapy as described in the 2 DBT treatment manuals (Linehan, 1993a,b).
• PTSD Protocol
A modified version of Prolonged Exposure therapy for PTSD

Locations

Country	Name	City	State
United States	Behavioral Research and Therapy Clinics, University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Harned MS, Korslund KE, Foa EB, Linehan MM. Treating PTSD in suicidal and self-injuring women with borderline personality disorder: development and preliminary evaluation of a Dialectical Behavior Therapy Prolonged Exposure Protocol. Behav Res Ther. 2012 — View Citation

Harned MS, Korslund KE, Linehan MM. A pilot randomized controlled trial of Dialectical Behavior Therapy with and without the Dialectical Behavior Therapy Prolonged Exposure protocol for suicidal and self-injuring women with borderline personality disorder — View Citation

Harned MS, Ruork AK, Liu J, Tkachuck MA. Emotional Activation and Habituation During Imaginal Exposure for PTSD Among Women With Borderline Personality Disorder. J Trauma Stress. 2015 Jun;28(3):253-7. doi: 10.1002/jts.22013. — View Citation

Harned MS, Tkachuck MA, Youngberg KA. Treatment preference among suicidal and self-injuring women with borderline personality disorder and PTSD. J Clin Psychol. 2013 Jul;69(7):749-61. doi: 10.1002/jclp.21943. Epub 2013 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptom Scale - Interview	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	No
Primary	Suicide Attempt Self-Injury Interview	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	Yes
Secondary	Treatment History Interview	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	No
Secondary	Hamilton Rating Scale for Depression	An interview measuring symptoms of depression.	Pre-treatment, 4-, 8-, 12-, and 15-months	No
Secondary	Dissociative Experiences Scale	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	No
Secondary	Suicidal Behaviors Questionnaire	A self-report measure of suicide ideation, suicide expectancies, and suicide threats and communications.	Pre-treatment, 4-, 8-, 12-, and 15-months	No

External Links

•   Behavioral Research and Therapy Clinics