Clinical trial NCT01081314: Treating PTSD in Patients With Borderline Personality Disorder
Official title: Treating PTSD in Patients With Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stress Disorders, Post-Traumatic
Borderline Personality Disorder
Suicide
Self-Injurious Behavior
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-03-05
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: PTSD Symptom Scale - Interview
timeFrame: Pre-treatment, 4-, 8-, 12-, and 15-months
measure: Suicide Attempt Self-Injury Interview
timeFrame: Pre-treatment, 4-, 8-, 12-, and 15-months
Secondary outcomes:
measure: Treatment History Interview
timeFrame: Pre-treatment, 4-, 8-, 12-, and 15-months
measure: Hamilton Rating Scale for Depression
timeFrame: Pre-treatment, 4-, 8-, 12-, and 15-months
measure: Dissociative Experiences Scale
timeFrame: Pre-treatment, 4-, 8-, 12-, and 15-months
measure: Suicidal Behaviors Questionnaire
timeFrame: Pre-treatment, 4-, 8-, 12-, and 15-months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Behavioral Research and Therapy Clinics, University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Melanie S Harned, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.