跳至主要内容
临床试验/NCT02695953
NCT02695953Enrolling By Invitation不适用

Neurobiology of Posttraumatic Stress Disorder Dysfunction and Recovery Following Cognitive Processing Therapy

Milissa Kaufman2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
130
试验地点
2
主要终点
Potential Change in Evidence of PTSD symptoms with neuroimaging

研究概览

简要总结

Posttraumatic stress disorder (PTSD) is a significant personal and societal burden. The purpose of this study is to examine genetic, epigenetic, behavioral, and brain activity changes related to PTSD dysfunction and recovery before and after treatment with Cognitive Processing Therapy.

详细描述

Using functional magnetic resonance imaging approaches, the present research aims to examine the relationship between traumatic experience and the neural mechanisms of various PTSD symptoms, and determine how this relationship changes during PTSD extinction. Also, this proposal aims to better understand how the genetic/epigenetic profile of several genes predicts, and perhaps changes, in response to recovery from PTSD along with its neural correlates. This understanding will help identify individuals who will respond most optimally to a specific empirically based PTSD treatment, Cognitive Processing Therapy, while further connecting genetic biomarkers of risk with neural intermediate phenotypes underlying PTSD symptomatology.This study is observational as the investigator does not assign specific interventions to the participants of the study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • PTSD diagnosis, as measured by the Clinician Administered PTSD Scale for DSM-5
  • history of chronic childhood trauma due to relational abuse
  • Ability to understand and sign informed consent
  • Enrollment in CPT program at McLean Hospital
  • Both genders, all ethnic backgrounds, age between 18 and 55
  • Fluent English speakers
  • Normal or Corrected Vision

排除标准

  • History or current schizophrenia spectrum disorder or other psychotic disorders
  • History or current bipolar or other related disorders
  • Alcohol and/or substance use disorder within the past month
  • Metal implants
  • Medical or neurological illness (e.g., seizures, head injury in which they experienced a loss of consciousness)
  • Positive pregnancy test

结局指标

主要结局

Potential Change in Evidence of PTSD symptoms with neuroimaging

时间窗: Within 30 days before and again within 30 days after Cognitive Processing Therapy Treatment.

次要结局

未报告次要终点

研究者

发起方
Milissa Kaufman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Milissa Kaufman

Medical Director, Hill Center for Women

Mclean Hospital

研究点 (2)

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