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Enrolling by invitation NCT02757339

Evaluating the Neurobiological Basis of Traumatic Dissociation in Women With Histories of Abuse and Neglect

Observational Posttraumatic Stress Disorders Dissociative Identity Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Posttraumatic Stress Disorders, Dissociative Identity Disorder. Basic parameters: 18 years — 89 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Change from Baseline correlates of traumatic dissociation in Functional Magnetic Resonance Imaging at 36 to 56 weeks [Time frame: Baseline and 36 to 56 weeks after baseline]

Eligibility criteria

Inclusion criteria

  • Female
  • 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

Exclusion criteria

  • Male
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • McLean Hospital — Belmont

Identifiers

NCT: NCT02757339 · 2014P001429

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗