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

Posttraumatic Stress Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02757339
• Other study ID #: 2014P001429
• Status: Enrolling by invitation
• Start date: June 2015
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dissociative Disorders
• Dissociative Identity Disorder
• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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