跳至主要内容
临床试验/NCT02757339
NCT02757339Enrolling By Invitation不适用

Evaluating the Neurobiological Basis of Traumatic Dissociation in a Cross-Diagnostic Sample of Women With Histories of Childhood Abuse and Neglect

Mclean Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
2
主要终点
Change from Baseline correlates of traumatic dissociation in Functional Magnetic Resonance Imaging at 36 to 56 weeks

研究概览

简要总结

This study aims to evaluate the neurobiological basis of traumatic dissociation in a cross-diagnostic sample of women who have histories of childhood abuse and neglect.

详细描述

Dissociative symptoms commonly are associated with exposure to traumatic stress. Preliminary evidence from functional magnetic resonance imaging-based analysis (fMRI) of neural activation during dissociative symptom provocation in patients with PTSD or DID has implicated certain key structures involved in the generation of dissociative symptoms. Given the presumed region-to-region neural interplay implicit within this model, the investigators believe the use of intrinsic functional connectivity MRI (fcMRI) represents a valuable next line of investigation into the neurobiology of traumatic dissociation. The investigators also believe that a genetic approach holds promise as another converging line of inquiry into our understanding of traumatic dissociation.

To evaluate the neurobiological basis of traumatic dissociation, this study will recruit patients with PTSD or DID, and recruit matched controls to identify neurobiological correlates of traumatic dissociation.The study will compare the phenomenology of traumatic dissociation in patients with different PTSD subtypes and DID using standardized measures to look at the neurological and genetic correlates.

This study will also include a follow up visit that includes neuroimaging and genetic assessments.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of PTSD or DID and history of childhood abuse, or healthy controls
  • Age between 18 and 89
  • Legal and mental competency of the patient

排除标准

  • Under 18 or over 89
  • Legal or mental incompetence
  • Delirium secondary to medical illness
  • PTSD or DID due to general medical or neurological illness
  • History of neurological conditions that may cause significant psychiatric symptomatology (e.g., dementia)
  • Any contraindication to MR scans, including claustrophobia, pregnancy, metal implants, etc.
  • Current alcohol or substance dependence or abuse (within the last month)
  • A history of schizophrenia or other psychotic disorder
  • History of head injury or loss of consciousness for longer than 5 min (including concussion)

结局指标

主要结局

Change from Baseline correlates of traumatic dissociation in Functional Magnetic Resonance Imaging at 36 to 56 weeks

时间窗: Baseline and 36 to 56 weeks after baseline

Study participation will involve a baseline 60 minute cognitive assessment and a 60 minute Magnetic Resonance Imaging (MRI) at the 3 Tesla magnet in the McLean Hospital Imaging Center focusing on attention, emotion regulation, and symptoms of depersonalization. The first time point is baseline.The second time point will be 36-56 weeks after the baseline 60 minute Magnetic Resonance Imaging (MRI) scan at the 3 Tesla magnet in the McLean Hospital Imaging Center.

次要结局

未报告次要终点

研究者

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

Milissa Kaufman

Director of The Dissociative Disorders and Trauma Research Program

Mclean Hospital

研究点 (2)

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