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

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ClinicalTrials.gov Identifier: NCT02695953
Recruitment Status : Enrolling by invitation
First Posted : March 2, 2016
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Kerry Ressler, Mclean Hospital

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.

Condition or disease
Posttraumatic Stress Disorder

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.

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Study Type : Observational
Estimated Enrollment : 102 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neurobiology of Posttraumatic Stress Disorder Dysfunction and Recovery Following Cognitive Processing Therapy
Study Start Date : March 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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. ]

Biospecimen Retention:   Samples With DNA
Saliva sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695953


Locations
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Kerry Ressler
Investigators
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Principal Investigator: Kerry J Ressler, MD/PhD Mclean Hospital

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Responsible Party: Kerry Ressler, Chief Scientific Officer, Mclean Hospital
ClinicalTrials.gov Identifier: NCT02695953     History of Changes
Other Study ID Numbers: 2015P001812
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kerry Ressler, Mclean Hospital:
PTSD
biomarker
Cognitive Processing Therapy

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders