Does Psychotherapy Change the Gut Microbiome in Women of Child-bearing Age?

NCT07200531 | Recruiting

• 1 other identifier: 0613-25-EP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if group therapy for six weeks changes the gut microbiome in women. The main questions it aims to answer are: Is chronic stress associated with the gut microbiome? Will six weeks of therapy change the gut microbiota? Participants will: Answer questionnaires about chronic stress Mail a stool sample before and after the intervention. Participate in a 1-hour group therapy session over the course of six weeks.

Conditions

Chronic Stress

Keywords

Gut Microbiome; Life-course trauma; Psychotherapy

Outcome Measures

Primary Outcomes (2)

• Depression, Anxiety, and Stress Scales

  Self-report mood disorder questionnaire

  6 weeks

• Perceived Stress

  self-report questionnaire of perceived stress

  6 weeks

Study Arms (1)

Psychotherapy Intervention

EXPERIMENTAL

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

6-week psychotherapy group intervention

Psychotherapy Intervention

Eligibility Criteria

• Age: 19 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women over the age of 19 and less than 54. Able to understand/read English

You may not qualify if:

• Pregnant women and breast-feeding women Women who are actively participating in psychotherapy on a regular basis

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

MeSH Terms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Ashley J Blount, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley J Blount, PhD

CONTACT

4025596613; ablount@unomaha.edu

Tiffany A Moore, PhD, RN

CONTACT

4025596613; tamoore@unmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: October 1, 2025
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)