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临床试验/NCT02874131
NCT02874131已完成不适用

Behavioral Activation + Cognitive Processing Therapy for Posttraumatic Stress Disorder and Comorbid Major Depressive Disorder

United States Naval Medical Center, San Diego2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Montgomery-Asberg Depression Rating Scale (MADRS)

研究概览

简要总结

This study is a randomized controlled trial comparing an integrated treatment, Behavioral Activation + Cognitive Processing Therapy (BA + CPT), to CPT alone among active-duty service members with posttraumatic stress disorder (PTSD) and comorbid major depressive disorder (MDD). Participants will complete assessor-administered and self-report measures at pre- and post-treatment assessments, as well as a 3-month follow-up. Additionally, participants will complete self-report measures of PTSD and MDD symptoms at each therapy session.

详细描述

Major depressive disorder (MDD) is the psychological condition most commonly comorbid with posttraumatic stress disorder (PTSD). PTSD and MDD comorbidity is associated with greater symptom severity, lower levels of functioning, greater disability, and increased suicide potential relative to PTSD or MDD alone. Unfortunately, no psychological treatment intervention specifically addresses this comorbidity. Individuals with comorbid PTSD and MDD often receive evidence-based treatments for PTSD, such as cognitive processing therapy (CPT); although such treatments typically reduce both PTSD and depression symptoms, few studies have specifically examined these outcomes in individuals with PTSD and comorbid MDD. The primary goal of this randomized controlled trial is to evaluate whether greater improvement in depression symptoms can be achieved by augmenting CPT with behavioral activation (BA), a standard depression treatment, for active-duty service members with PTSD and comorbid MDD. Participants will be evaluated at three assessment time-points (pre-treatment, post-treatment, and three-month follow-up), as well as complete self-report measures of PTSD and MDD symptoms at each therapy session.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Active-duty service member seeking mental health treatment at Naval Medical Center San Diego (NMCSD), branch clinics, or Naval Hospital Camp Pendleton (NHCP)
  • Meet current diagnostic criteria for PTSD based on the DSM-5 as a consequence of any index traumatic event (e.g., combat, military sexual trauma, child abuse, accidents, etc.)
  • Meet current diagnostic criteria for MDD based on DSM-5 criteria.

排除标准

  • Unmanaged psychosis or manic episode in the past year
  • Substance use disorder warranting primary substance use treatment or detoxification
  • Participation in concurrent psychotherapies directly targeting PTSD
  • Participation in concurrent psychotherapies directly targeting depression

结局指标

主要结局

Montgomery-Asberg Depression Rating Scale (MADRS)

时间窗: Prior to beginning treatment through three months following treatment completion (approximately 10 months)

Assessor-administered measure of depression symptoms

次要结局

  • Patient Health Questionnaire (PHQ-9)(Prior to beginning treatment through three months following treatment completion (approximately 10 months))
  • Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5)(Prior to beginning treatment through three months following treatment completion (approximately 10 months))

研究者

发起方
United States Naval Medical Center, San Diego
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Kristen Walter

Clinical Research Psychologist

United States Naval Medical Center, San Diego

研究点 (2)

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