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

• Conditions: Posttraumatic Stress Disorder

• Registration Number: NCT02695953
• Lead Sponsor: Milissa Kaufman

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-24
• Study Start: 2016-03
• Study First Posted: 2016-03-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 130

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Potential Change in Evidence of PTSD symptoms with neuroimaging	Within 30 days before and again within 30 days after Cognitive Processing Therapy Treatment.

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States