MedDataX Logo

Treating PTSD in Patients With Borderline Personality Disorder

NCT ID: NCT01081314

Last Updated: 2015-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Dialectical Behavior Therapy

Intervention Type BEHAVIORAL

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

PTSD Protocol

Intervention Type BEHAVIORAL

A modified version of Prolonged Exposure therapy for PTSD

Standard DBT

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

Group Type ACTIVE_COMPARATOR

Dialectical Behavior Therapy

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dialectical Behavior Therapy

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

Intervention Type BEHAVIORAL

PTSD Protocol

A modified version of Prolonged Exposure therapy for PTSD

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melanie Harned

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melanie S Harned, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Behavioral Research and Therapy Clinics, University of Washington

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 26062135 (View on PubMed)

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.

Reference Type RESULT
PMID: 24562087 (View on PubMed)

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.

Reference Type RESULT
PMID: 23444147 (View on PubMed)

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.

Reference Type RESULT
PMID: 22503959 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33884617 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32216138 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://depts.washington.edu/brtc/

Behavioral Research and Therapy Clinics

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R34MH082143

Identifier Type: NIH

Identifier Source: secondary_id

View Link

36517-C

Identifier Type: -

Identifier Source: org_study_id