Neurobiology of Posttraumatic Stress Disorder Dysfunction and Recovery Following Cognitive Processing Therapy
1 other identifier
observational
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
June 25, 2026
June 1, 2026
11.3 years
February 11, 2016
June 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Potential Change in Evidence of PTSD symptoms with neuroimaging
Within 30 days before and again within 30 days after Cognitive Processing Therapy Treatment.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milissa Kaufmanlead
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
Biospecimen
Saliva sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Milissa L Kaufman, MD/PhD
Mclean Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Director, Hill Center for Women
Study Record Dates
First Submitted
February 11, 2016
First Posted
March 2, 2016
Study Start
March 1, 2016
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
June 25, 2026
Record last verified: 2026-06