NCT01081314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 23, 2015

Status Verified

November 1, 2015

Enrollment Period

3.8 years

First QC Date

March 3, 2010

Last Update Submit

November 20, 2015

Conditions

Stress Disorders, Post-TraumaticBorderline Personality DisorderSuicideSelf-Injurious Behavior

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (4)

  • Treatment History Interview

    Pre-treatment, 4-, 8-, 12-, and 15-months

  • Hamilton Rating Scale for Depression

    Pre-treatment, 4-, 8-, 12-, and 15-months

  • Dissociative Experiences Scale

    Pre-treatment, 4-, 8-, 12-, and 15-months

  • Suicidal Behaviors Questionnaire

    Pre-treatment, 4-, 8-, 12-, and 15-months

Study Arms (2)

Standard DBT + PTSD Protocol

EXPERIMENTAL

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 TherapyBehavioral: PTSD Protocol

Standard DBT

ACTIVE COMPARATOR

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

Behavioral: Dialectical Behavior Therapy

Interventions

Dialectical Behavior TherapyBEHAVIORAL

Standard Dialectical Behavior Therapy as described in the 2 DBT treatment manuals (Linehan, 1993a,b).

Standard DBTStandard DBT + PTSD Protocol
PTSD ProtocolBEHAVIORAL

A modified version of Prolonged Exposure therapy for PTSD

Standard DBT + PTSD Protocol

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Research and Therapy Clinics, University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (6)

  • 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.

    PMID: 26062135RESULT

  • 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.

    PMID: 24562087RESULT

  • 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.

    PMID: 23444147RESULT

  • 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.

    PMID: 22503959RESULT

  • 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.

    PMID: 33884617DERIVED

  • 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.

    PMID: 32216138DERIVED

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticBorderline Personality DisorderSuicideSelf-Injurious Behavior

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPersonality DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Melanie S Harned, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 5, 2010

Study Start

August 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 23, 2015

Record last verified: 2015-11

Locations

US(1)