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Examining Changes in Microbiota Over the Course of PTSD Treatment

NCT04109196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-06-22

Study results available
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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 cytokines, and the presence of and recovery from PTSD. Specifically, this study is designed to 1) determine whether individual Cognitive Processing Therapy (CPT) delivered twice per day over 5 consecutive days (CPT-5) is tolerable, acceptable, and effective in reducing PTSD symptoms, 2) determine the microbial signatures associated with PTSD, 3) evaluate whether the abundance and composition of microbiota and salivary cytokine levels change over the course of PTSD treatment, and 4) examine whether changes in microbial signatures are associated with changes in cytokine levels.

Conditions

Interventions

BEHAVIORAL

Cognitive Processing Therapy

Cognitive Processing Therapy is an evidence-based treatment for PTSD that will be delivered intensively twice per day over the course of five days.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Chicago

    collaborator OTHER

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Rush University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-04-09
Completion
2021-04-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04109196 on ClinicalTrials.gov