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

NCT ID: NCT02695953

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2026-05-31

Brief Summary

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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

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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.

Conditions

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Posttraumatic Stress Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milissa Kaufman

OTHER

Sponsor Role lead

Responsible Party

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Milissa Kaufman

Medical Director, Hill Center for Women

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Milissa L Kaufman, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2015P001812

Identifier Type: -

Identifier Source: org_study_id

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