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NCT02695953 Clinical Trial

Neurobiology of Posttraumatic Stress Disorder Dysfunction and Recovery Following Cognitive Processing Therapy

Posttraumatic Stress Disorder Clinical Trial

Official title:
Neurobiology of Posttraumatic Stress Disorder Dysfunction and Recovery Following Cognitive Processing Therapy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02695953
Other study ID # 2015P001812
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 2016
Est. completion date May 2025

Study information
Verified date March 2024
Source Mclean Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Posttraumatic stress disorder (PTSD) is a significant personal and societal burden. The purpose of this study is to examine genetic, epigenetic, behavioral, and brain activity changes related to PTSD dysfunction and recovery before and after treatment with Cognitive Processing Therapy.

Description:

Using functional magnetic resonance imaging approaches, the present research aims to examine the relationship between traumatic experience and the neural mechanisms of various PTSD symptoms, and determine how this relationship changes during PTSD extinction. Also, this proposal aims to better understand how the genetic/epigenetic profile of several genes predicts, and perhaps changes, in response to recovery from PTSD along with its neural correlates. This understanding will help identify individuals who will respond most optimally to a specific empirically based PTSD treatment, Cognitive Processing Therapy, while further connecting genetic biomarkers of risk with neural intermediate phenotypes underlying PTSD symptomatology.This study is observational as the investigator does not assign specific interventions to the participants of the study.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 130
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - PTSD diagnosis, as measured by the Clinician Administered PTSD Scale for DSM-5 - history of chronic childhood trauma due to relational abuse - Ability to understand and sign informed consent - Enrollment in CPT program at McLean Hospital - Both genders, all ethnic backgrounds, age between 18 and 55 - Fluent English speakers - Normal or Corrected Vision Exclusion Criteria: - History or current schizophrenia spectrum disorder or other psychotic disorders - History or current bipolar or other related disorders - Alcohol and/or substance use disorder within the past month - Metal implants - Medical or neurological illness (e.g., seizures, head injury in which they experienced a loss of consciousness) - Positive pregnancy test

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States McLean Hospital Belmont Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Milissa Kaufman

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Potential Change in Evidence of PTSD symptoms with neuroimaging Within 30 days before and again within 30 days after Cognitive Processing Therapy Treatment.
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