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临床试验/NCT01081314
NCT01081314已完成1 期

Treating PTSD in Patients With Borderline Personality Disorder

University of Washington2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
39
试验地点
2
主要终点
PTSD Symptom Scale - Interview

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

PTSD Symptom Scale - Interview

时间窗: Pre-treatment, 4-, 8-, 12-, and 15-months

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

时间窗: Pre-treatment, 4-, 8-, 12-, and 15-months

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melanie Harned

Professor

University of Washington

研究点 (2)

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