Examining Changes in Microbiota Over the Course of PTSD Treatment

NCT04109196 | Completed Results

• 2 other identifiers: 180110055KL2TR002387-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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

Posttraumatic Stress Disorder; Depression

Outcome Measures

Primary Outcomes (9)

• PTSD Checklist for DSM-5 (PCL-5)

  This will be used to assess severity of posttraumatic stress disorder symptoms at intake.The PTSD Checklist for DSM-5 (PCL-5) measures severity of PTSD symptoms. This questionnaire includes 20 items, which each item rated on a scale of 0 (not at all)-4 (extremely). There are four subscales reflecting symptom clusters in the DSM-5: intrusion (five items), avoidance (two items), negative alterations in cognitions and mood (seven items), and alterations in arousal and reactivity (six items). All 20 items are summed to calculate a total score. Scores range from 0-80, with higher scores indicating more severe symptoms.

  Baseline

• Change in PTSD Checklist for DSM-5 (PCL-5) From Baseline

  This will be used to assess changes in posttraumatic stress disorder symptom severity from baseline to the time points described below and/or changes between the time points described below. The PTSD Checklist for DSM-5 (PCL-5) measures severity of PTSD symptoms. This questionnaire includes 20 items, which each item rated on a scale of 0 (not at all)-4 (extremely). There are four subscales reflecting symptom clusters in the DSM-5: intrusion (five items), avoidance (two items), negative alterations in cognitions and mood (seven items), and alterations in arousal and reactivity (six items). All 20 items are summed to calculate a total score. Scores range from 0-80, with higher scores indicating more severe symptoms.

  1 week post-treatment, 3 months post treatment

• Patient Health Questionnaire-9 (PHQ-9)

  This will be used to assess severity of depression symptoms at intake. The Patient Health Quetionnaire-9 (PHQ-9) measures severity of depression symptoms. This questionnaire includes 10 items, with each item rated on a scale of 0 (not at all)-3 (nearly every day). The first 9 items are summed to calculate a total score. Scores range from 0-27, with higher scores indicating more severe symptoms. The tenth item (also rated 0-3) is not included in the total score, but indicates how much interference the responder experiences in their day to day life due to symptoms they are experiencing.

  Baseline

• Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline

  This will be used to assess changes in depression symptom severity from baseline to the time points described below and/or changes between the time points described below. This will be used to assess severity of depression symptoms at intake. The Patient Health Quetionnaire-9 (PHQ-9) measures severity of depression symptoms. This questionnaire includes 10 items, with each item rated on a scale of 0 (not at all)-3 (nearly every day). The first 9 items are summed to calculate a total score. Scores range from 0-27, with higher scores indicating more severe symptoms. The tenth item (also rated 0-3) is not included in the total score, but indicates how much interference the responder experiences in their day to day life due to symptoms they are experiencing.

  1 week post-treatment, 3 months post-treatment

• Change in DNA Genotek OMNIgeneGUT for Microbiome Kit (OMR-200) From Baseline

  Change in microbial signature (abundance and composition) from colonic fecal sample from baseline to the time points described below and/or changes between the time points described below.

  Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment

• DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501)

  Microbial signature (abundance and composition) from oral saliva sample collected at intake.

  Baseline

• Change in DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501) From Baseline

  Change in microbial signature (abundance and composition) from oral saliva sample from baseline to the time points described below and/or changes between the time points described below.

  Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment

• Salimetrics Salivary Cytokine Panel

  Salivary cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-8) from oral saliva sample collected at intake.

  Baseline

• Change in Salimetrics Salivary Cytokine Panel From Baseline

  Change in salivary cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-8) from baseline to the time points described below and/or changes between the time points described below.

  Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment

Secondary Outcomes (2)

• Posttraumatic Cognitions Inventory (PTCI)

  Baseline

• Change in Posttraumatic Cognitions Inventory (PTCI) From Baseline

  1 week post-treatment

Study Arms (1)

Intensive 5-day Cognitive Processing Therapy for PTSD

EXPERIMENTAL

Participants who are eligible for and enrolled in the study will receive a 5-day CPT treatment for PTSD. All participants will be asked to complete clinician-rated and self-report assessments at multiple time points during the study. Participants will also be asked to provide fecal and saliva samples as part of the study, however, they may opt out of biological sample collection.

Behavioral: Cognitive Processing Therapy

Interventions

Cognitive Processing Therapy BEHAVIORAL

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

Intensive 5-day Cognitive Processing Therapy for PTSD

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Institutes of Health (NIH): collaborator
• University of Chicago: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Philip Held
• Organization: Rush University Medical Center

philip_held@rush.edu

312-942-1423

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: All participants who are eligible for this study will receive a 5 day PTSD treatment.

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 30, 2019
• Study Start: October 1, 2019
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-06

Locations

US (1)