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Psychotherapy

CPT + Prebiotics for PTSD

N/A

Waitlist Available

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will compare Cognitive Processing Therapy (CPT) with and without a prebiotic bar to see if the combination can help improve symptoms of PTSD.

Who is the study for?

This trial is for veterans enrolled in the Rush Road Home Program's Intensive Outpatient Program who have PTSD. They must be able to consent, eat up to two bars daily, and provide stool samples. Excluded are those with certain GI diseases, recent antibiotic use, major dietary changes planned, nut allergies, severe psychiatric conditions or substance abuse issues.Check my eligibility

What is being tested?

The study tests if a prebiotic bar can improve PTSD treatment outcomes when combined with Cognitive Processing Therapy (CPT). Participants will either receive CPT plus a prebiotic bar or CPT plus a placebo non-prebiotic bar over 12 weeks in a randomized and blinded setup.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort due to the prebiotic content of the bars such as bloating or gas. Since this is an addition to standard therapy (CPT), other side effects might relate to individual reactions to ingredients like almonds, flax seed or coconuts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PTSD symptoms scores

Changes in microbiota community structure & function

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Prebiotic Bar GroupActive Control1 Intervention

Participants will be asked to consume prebiotic bars for the duration of the trial.

Group II: Placebo Non-Prebiotic Bar GroupPlacebo Group1 Intervention

This group of participants will be consuming non-prebiotic bars for the duration of the trial.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,451 Total Patients Enrolled

Cures Within ReachOTHER

19 Previous Clinical Trials

1,663 Total Patients Enrolled

Media Library

CPT (Psychotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05424146 — N/A

Post-Traumatic Stress Disorder Research Study Groups: Placebo Non-Prebiotic Bar Group, Prebiotic Bar Group

Post-Traumatic Stress Disorder Clinical Trial 2023: CPT Highlights & Side Effects. Trial Name: NCT05424146 — N/A

CPT (Psychotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424146 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period still open for this research endeavor?

"Indeed, the clinicaltrials.gov website states that this investigation is actively seeking participants. This trial was first published on June 6th 2022 and has been recently updated on June 15th of the same year. The research team requires 78 volunteers from a single site to participate in their study."

Answered by AI

How many participants have been recruited for this medical experiment?

"Affirmative. Data hosted on clinicaltrials.gov establishes that the trial is currently recruiting, with postings starting from June 6th 2022 and most recently updated 15 days later. 78 participants are needed for this single-site study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation

Robin Voigt 2022. "Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424146.

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