N/A
N=24
Examining Changes in Microbiota Over the Course of PTSD Treatment
Posttraumatic Stress Disorder · Depression
Bottom Line
View on ClinicalTrials.gov: NCT04109196 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: PTSD Checklist for DSM-5 (PCL-5) — 53.08 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Processing Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PTSD Checklist for DSM-5 (PCL-5) |
53.08 | — |
| PRIMARY Change in PTSD Checklist for DSM-5 (PCL-5) From Baseline |
17.55; 19.42 | — |
| PRIMARY Patient Health Questionnaire-9 (PHQ-9) |
15.38 | — |
| PRIMARY Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline |
7.73; 6.84 | — |
| PRIMARY Change in DNA Genotek OMNIgeneGUT for Microbiome Kit (OMR-200) From Baseline |
— | — |
| PRIMARY DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501) |
— | — |
| PRIMARY Change in DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501) From Baseline |
— | — |
| PRIMARY Salimetrics Salivary Cytokine Panel |
— | — |
| PRIMARY Change in Salimetrics Salivary Cytokine Panel From Baseline |
— | — |
| SECONDARY Posttraumatic Cognitions Inventory (PTCI) |
154.08 | — |
| SECONDARY Change in Posttraumatic Cognitions Inventory (PTCI) From Baseline |
89.23 | — |
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.
Eligibility Criteria
Inclusion Criteria
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 Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04109196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.