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

NCT02757339 | Enrolling By Invitation

• 1 other identifier: 2014P001429
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorders; Dissociative Identity Disorder

Keywords

neurobiology; PTSD; DID

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Study participants will provide a 2mm saliva sample.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Dissociative Identity Disorder

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Dissociative Disorders

Study Officials

• Milissa L Kaufman, M.D./Ph.D

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of The Dissociative Disorders and Trauma Research Program

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: May 2, 2016
• Study Start: June 1, 2015
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Locations

US (1)