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

June 22, 2026 updated by: Milissa Kaufman
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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will include 102 individuals (half female) between the ages of 18 and 55 with a current diagnosis of PTSD as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). Participants must have a history of chronic childhood trauma due to relational abuse. All participants will be recruited from the McLean Hospital outpatient trauma track Cognitive Processing Therapy (CPT) treatment program.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Potential Change in Evidence of PTSD symptoms with neuroimaging
Time Frame: Within 30 days before and again within 30 days after Cognitive Processing Therapy Treatment.
Within 30 days before and again within 30 days after Cognitive Processing Therapy Treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milissa Kaufman

Investigators

  • Principal Investigator: Milissa L Kaufman, MD/PhD, McLean Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 11, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimated)

March 2, 2016

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P001812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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