Does Psychotherapy Change the Gut Microbiome in Women of... | NCT07200531

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

NCT07200531

Sponsor

University of Nebraska

Status

Recruiting

Last Update Posted

Mar 25, 2026Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Chronic Stress

Interventions

Psychotherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Actual

Primary Completion Date

Apr 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Aug 23, 2025

First Submission Date that Met QC Criteria

Sep 26, 2025

First Posted Date

Oct 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psychotherapy Intervention	Experimental		Behavioral: Psychotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psychotherapy	Behavioral	6-week psychotherapy group intervention	Psychotherapy Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depression, Anxiety, and Stress Scales	Self-report mood disorder questionnaire	6 weeks
Perceived Stress	self-report questionnaire of perceived stress	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

54 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ashley J Blount, PhD	Contact	4025596613		ablount@unomaha.edu
Tiffany A Moore, PhD, RN	Contact	4025596613		tamoore@unmc.edu

Overall Officials

Name	Affiliation	Role
Ashley J Blount, PhD	University of Nebraska	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nebraska Medical Center	Recruiting	Omaha	Nebraska	68198	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

This is a small pilot study.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011613	Psychotherapy

Ancestor Terms

ID	Term
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided