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Stress Disorders, Post-TraumaticPhase 1/2NCT01081314

Treating PTSD in Patients With Borderline Personality Disorder

A Phase 1/2 study testing Dialectical Behavior Therapy and PTSD Protocol in people with Stress Disorders, Post-Traumatic and Borderline Personality Disorder, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
What is being tested?
Dialectical Behavior Therapy and PTSD Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
Aug 2009to May 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Behavioral Research and Therapy Clinics, University of Washington

    Seattle, Washington, 98105

Other trials in United States

About this study

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.

Being tested
Dialectical Behavior Therapy, PTSD Protocol
Medical subject headings
Stress Disorders, Post-Traumatic, Borderline Personality Disorder, Suicide, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialectical Behavior TherapyBehavioural

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

  • PTSD ProtocolBehavioural

    A modified version of Prolonged Exposure therapy for PTSD

Study groups in NCT01081314
Study groupRoleWhat they receive
Standard DBT + PTSD ProtocolExperimentalIncludes 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.
Receives: Behavioral: Dialectical Behavior Therapy; Behavioral: PTSD Protocol
Standard DBTActive comparatorIncludes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).
Receives: Behavioral: Dialectical Behavior Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

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

Secondary outcomes (4)

  1. 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.

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

  2. Hamilton Rating Scale for Depression

    An interview measuring symptoms of depression.

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

  3. 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.

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

  4. Suicidal Behaviors Questionnaire

    A self-report measure of suicide ideation, suicide expectancies, and suicide threats and communications.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2010 (estimated)
  2. Study startAug 2009
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01081314
Sponsor's protocol ID
36517-C
Other IDs
R34MH082143
Status last verified
Nov 2015
First submitted
3 Mar 2010
Last updated
23 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26062135

  • 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.

    PubMed 24562087

  • 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.

    PubMed 23444147

  • 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.

    PubMed 22503959

  • 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.

    PubMed 33884617

  • 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.

    PubMed 32216138

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dialectical Behavior Therapy and PTSD Protocol in people with Stress Disorders, Post-Traumatic and Borderline Personality Disorder, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD Symptom Scale - Interview (time frame: Pre-treatment, 4-, 8-, 12-, and 15-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01081314, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.

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