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Treating PTSD in Patients With Borderline Personality Disorder

Primary Purpose

Stress Disorders, Post-Traumatic, Borderline Personality Disorder, Suicide

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dialectical Behavior Therapy
PTSD Protocol
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Behavioral Research and Therapy Clinics, University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard DBT + PTSD Protocol

Standard DBT

Arm Description

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.

Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
Hamilton Rating Scale for Depression
An interview measuring symptoms of depression.
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.
Suicidal Behaviors Questionnaire
A self-report measure of suicide ideation, suicide expectancies, and suicide threats and communications.

Full Information

First Posted
March 3, 2010
Last Updated
November 20, 2015
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01081314
Brief Title
Treating PTSD in Patients With Borderline Personality Disorder
Official Title
Treating PTSD in Patients With Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Borderline Personality Disorder, Suicide, Self-Injurious Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard DBT + PTSD Protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard DBT
Arm Type
Active Comparator
Arm Description
Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy
Intervention Description
Standard Dialectical Behavior Therapy as described in the 2 DBT treatment manuals (Linehan, 1993a,b).
Intervention Type
Behavioral
Intervention Name(s)
PTSD Protocol
Intervention Description
A modified version of Prolonged Exposure therapy for PTSD
Primary Outcome Measure Information:
Title
PTSD Symptom Scale - Interview
Description
A structured clinical interview that measures both the presence and severity of the 17 DSM-IV PTSD symptoms related to specific trauma(s).
Time Frame
Pre-treatment, 4-, 8-, 12-, and 15-months
Title
Suicide Attempt Self-Injury Interview
Description
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.
Time Frame
Pre-treatment, 4-, 8-, 12-, and 15-months
Secondary Outcome Measure Information:
Title
Treatment History Interview
Description
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.
Time Frame
Pre-treatment, 4-, 8-, 12-, and 15-months
Title
Hamilton Rating Scale for Depression
Description
An interview measuring symptoms of depression.
Time Frame
Pre-treatment, 4-, 8-, 12-, and 15-months
Title
Dissociative Experiences Scale
Description
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.
Time Frame
Pre-treatment, 4-, 8-, 12-, and 15-months
Title
Suicidal Behaviors Questionnaire
Description
A self-report measure of suicide ideation, suicide expectancies, and suicide threats and communications.
Time Frame
Pre-treatment, 4-, 8-, 12-, and 15-months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie S Harned, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Research and Therapy Clinics, University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26062135
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.
Results Reference
result
PubMed Identifier
24562087
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 and PTSD. Behav Res Ther. 2014 Apr;55:7-17. doi: 10.1016/j.brat.2014.01.008. Epub 2014 Feb 11.
Results Reference
result
PubMed Identifier
23444147
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.
Results Reference
result
PubMed Identifier
22503959
Citation
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 Jun;50(6):381-6. doi: 10.1016/j.brat.2012.02.011. Epub 2012 Mar 11.
Results Reference
result
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
PubMed Identifier
32216138
Citation
Harned MS, Fitzpatrick S, Schmidt SC. Identifying Change Targets for Posttraumatic Stress Disorder Among Suicidal and Self-Injuring Women With Borderline Personality Disorder. J Trauma Stress. 2020 Aug;33(4):610-616. doi: 10.1002/jts.22504. Epub 2020 Mar 26.
Results Reference
derived
Links:
URL
http://depts.washington.edu/brtc/
Description
Behavioral Research and Therapy Clinics

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Treating PTSD in Patients With Borderline Personality Disorder

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