Status:
COMPLETED
Examining Changes in Microbiota Over the Course of PTSD Treatment
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
University of Chicago
Conditions:
Posttraumatic Stress Disorder
Depression
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The overall goals of this project are to evaluate the use of 5-day intensively-delivered Cognitive Processing Therapy to treat PTSD and to determine the associations between the microbiome, salivary c...
Detailed Description
This project will evaluate the use of 5-day intensively-delivered Cognitive Processing Therapy to treat PTSD and will aim to determine the associations between the microbiome, salivary cytokines, and ...
Eligibility Criteria
Inclusion
- Individuals are eligible for the study if they:
- Are 18 years or older
- Are fluent in English
- Have experienced a Criterion A traumatic event during their lifetime
- Have a PTSD diagnosis verified by the Clinician Administered PTSD Scale for DSM-5
- Are interested in receiving evidence-based treatment (CPT) for PTSD and able to attend 10 therapy sessions over the course of one week (5 days)
- Are willing and interested to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
Exclusion
- Individuals are excluded from the study if:
- The traumatic event occurred in the past month
- They are currently suicidal or homicidal, as indicated by a positive screen on the C-SSRS Question 4 or Question 5 at intake.
- They have a history of psychosis or mania
- They have not been on a stable dose of medication for at least one month
- They have dietary patterns not representative of normal populations (e.g., vegetarian, vegan, gluten-free)
- They made changes to the diet in the past month or are planning to make changes over the course of therapy
- They have completed an evidence-based PTSD treatment in the past 3 months or are currently receiving an evidence-based PTSD treatment
- They have mental retardation or significant cognitive impairment that would prevent them from engaging in CPT
- They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
- They have an active substance use disorder (within the past 3 months)
- They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment
- They have a history or presence of an eating disorder
- They are currently taking or have taken an antibiotic in the past 30 days
- They are currently taking a corticosteroid
- They have had part of the digestive tract removed or altered
- They have had any surgery or procedure within the past 30 days that has required fasting for more than 12 hours or bowel preparation beforehand
- They are unwilling to provide fecal and saliva samples (applies to trauma-exposed control condition only)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04109196
Start Date
October 1 2019
End Date
April 9 2021
Last Update
June 22 2023
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612