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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Posttraumatic Stress Disorders; Dissociative Identity Disorder

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll up to 90 female patients with either DID or PTSD ages 18-89. We will also recruit up to 60 control subjects matched for demographics (age, race, gender).

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Women with History of Childhood Abuse; The study will enroll up to 140 female patients with either DID or PTSD ages 18-89
Healthy Control Group; We will recruit up to 60 control subjects matched for demographics (age, race, gender).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline correlates of traumatic dissociation in Functional Magnetic Resonance Imaging at 36 to 56 weeks	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.	Baseline and 36 to 56 weeks after baseline

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Investigators: Principal Investigator: Milissa L Kaufman, M.D./Ph.D, McLean Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimated): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: PTSD; neurobiology; DID
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Dissociative Disorders; Dissociative Identity Disorder
• Other Study ID Numbers: 2014P001429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No