Chronic StressNCT07200531
Does Psychotherapy Change the Gut Microbiome in Women of Child-bearing Age?
A study testing Psychotherapy in people with Chronic Stress, run by University of Nebraska at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Stress
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 54 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women over the age of 19 and less than 54. Able to understand/read English
Who cannot join
- Pregnant women and breast-feeding women Women who are actively participating in psychotherapy on a regular basis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Impact of Biopsychosocial Psychotherapy Intervention on Maternal Life-Course Trauma and the Gut Microbiome
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
- Being tested
- Psychotherapy
- Keywords
- Gut Microbiome, Life-course trauma, Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
6-week psychotherapy group intervention
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy Intervention | Experimental | Not described Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety, and Stress Scales
Self-report mood disorder questionnaire
Measured: 6 weeks
Perceived Stress
self-report questionnaire of perceived stress
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Dec 2025
- Primary completion1 Apr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StressStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiffany Moore, University of Nebraska
- Investigators
- Ashley J Blount, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200531
- Sponsor's protocol ID
- 0613-25-EP
- Status last verified
- Dec 2025
- First submitted
- 23 Aug 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Biopsychosocial Psychotherapy Intervention on Maternal Life-Course Trauma and the Gut Microbiome
- ClinicalTrials.gov ID
- NCT07200531
- Acronym / sponsor ID
- 0613-25-EP
- Conditions
- Chronic Stress
- Keywords
- Gut Microbiome, Life-course trauma, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy Intervention | Experimental | Behavioral: Psychotherapy |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women over the age of 19 and less than 54. Able to understand/read English
Key exclusion criteria (1 listed)
- Pregnant women and breast-feeding women Women who are actively participating in psychotherapy on a regular basis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy6-week psychotherapy group intervention | Behavioural | Psychotherapy Intervention |
Primary outcome
Depression, Anxiety, and Stress Scales
Time frame: 6 weeks
Self-report mood disorder questionnaire
Perceived Stress
Time frame: 6 weeks
self-report questionnaire of perceived stress
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. This is a small pilot study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley J Blount, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Chronic Stress, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety, and Stress Scales (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.