Clinical trial NCT02695953: Neurobiology of Posttraumatic Stress Disorder Dysfunction and Recovery Following Cognitive Processing Therapy
Official title: Neurobiology of Posttraumatic Stress Disorder Dysfunction and Recovery Following Cognitive Processing Therapy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
biomarker
Cognitive Processing Therapy
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Potential Change in Evidence of PTSD symptoms with neuroimaging
timeFrame: Within 30 days before and again within 30 days after Cognitive Processing Therapy Treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Milissa L Kaufman, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: