Irritable Bowel SyndromeNCT07600047
A Well-Being Intervention for People With IBS
A study testing Well-Being Intervention in people with Irritable Bowel Syndrome, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this randomized behavioral clinical trial is to examine whether a well-being intervention can improve both psychological well-being and physical outcomes in adults with Irritable Bowel Syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Well-Being Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women currently diagnosed with Irritable Bowel Syndrome (IBS) by a healthcare provider.
- Able to read and write in English.
- Willing to complete questionnaires and participate in either the intervention or control group.
- Capable of providing informed consent.
- Must be a UW Health patient or referred through UW Digestive Health Center.
Who cannot join
- Individuals with cognitive impairments or reading difficulties that would interfere with understanding study materials or completing assessments.
- Individuals unable to provide informed consent.
- Prior participation in a similar intervention study.
- Non-English speakers (since study materials are in English)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UW Health Digestive Health Center
Madison, Wisconsin, 53705
About this study
The purpose of this randomized behavioral clinical trial is to examine whether a well-being intervention can improve both psychological well-being and physical outcomes in adults with Irritable Bowel Syndrome (IBS). The study aims to assess whether this intervention decreases anger, anxiety, and depression; increases self-esteem, empathy, and hope; and improves quality of life indicators such as IBS symptom severity, sleep quality, fatigue, and diet. Participants can expect to be on study for up to 9 months.
Read the detailed description
This study consists of two phases:
Study 1 (Screening and Baseline Assessment):
Participants who self-identify as having been diagnosed with IBS and receive care at the University of Wisconsin (UW) Digestive Health Center will complete a battery of self-report questionnaires assessing well-being, anger, anxiety, depression, self-esteem, empathy, hope, sleep quality, fatigue, diet, and IBS symptom severity.
Study 2 (Intervention Phase - registered here):
Eligible participants will be randomized to either an experimental well-being intervention or a waitlist control condition. Participants assigned to the waitlist control condition will not receive the intervention during the initial intervention period but will complete all scheduled assessments. After completion of the first post-test assessment, waitlist participants will receive the same 15-session well-being intervention (crossover design).
The intervention will be held once a week for 15 weeks, lasting approximately one hour per session, conducted in a private meeting room at the Digestive Health Center. Sessions focus on emotional awareness, perspective-taking, and developing the capacity to overcome hurt and resentment toward a person who acted unfairly.
Following completion, both groups will complete post-test and follow-up assessments identical to the baseline questionnaires. Qualitative interviews will be conducted to explore participants' experiences with the intervention.
[Note - so as not to bias participants, specific information about the intervention will be withheld until the study is complete]
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Well-Being Intervention
- Keywords
- well being
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-Being InterventionBehavioural
The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.
| Study group | Role | What they receive |
|---|---|---|
| Well-Being Intervention | Experimental | Not described Receives: Behavioral: Well-Being Intervention |
| Waitlist Control (delayed Well-Being Intervention) | Active comparator | Not described Receives: Behavioral: Well-Being Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anger measured by PROMIS Anger Scale Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anger Scale is scored from 5-25 where higher scores indicates more anger.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Anxiety measured by PROMIS Anxiety Scale Score
The PROMIS Anxiety Scale is scored from 7-35 where higher scores indicates more anxiety.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Depression measured by IBS PROMIS Depression Scale Score
The IBS PROMIS Depression Scale is scored from 8-40 where higher scores indicates more depression.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Fatigue measured by IBS Fatigue 8a Score
The IBS Fatigue 8a Scale is scored from 8-40 where higher scores indicates more fatigue.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Sleep Disturbance measured by IBS Sleep Disturbance 8b
The IBS Sleep Disturbance 8b Scale is scored from 8-40 where higher scores indicates more sleep disturbance.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Pain measured by Item 1b of the IBS Symptom Severity Scale
This item is scored from 0-100 where higher scores indicates increased pain.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
IBS Severity Score measured by IBS Symptom Severity Scale
The IBS Symptom Severity Scale is scored from 0-100 where higher scores indicates more severe IBS symptoms.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Well-Being measured by a 30 item Inventory
The inventory is scored from 30-180 where higher scores indicates greater level of well-being.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Self-esteem measured by Rosenberg Self Esteem Scale Score
The Rosenberg Self Esteem Scale is scored from 0-30 where higher scores indicates higher self esteem.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Empathy measured by Empathy Questionnaire
The Empathy Questionnaire is scored from 0-64 where higher scores indicates higher empathy.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Hope measured by Heart Hope Index Score
The Heart Hope Index is scored from 12-48 where higher scores indicates greater hope.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Healthy Diet Pattern measured by an IBS Diet Survey
The Diet Survey is scored from 5-24 where higher scores indicate healthier diet pattern.
Measured: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study startDec 2026 (estimated)
- Primary completionAug 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 Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Benson, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600047
- Sponsor's protocol ID
- 2025-1538
- Other IDs
- Protocol Approved 9/2/26, SMPH/DOM/Gastroent and Hepato
- Status last verified
- Sep 2026
- First submitted
- 13 May 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Well-Being Intervention for People With IBS
- ClinicalTrials.gov ID
- NCT07600047
- Acronym / sponsor ID
- 2025-1538
- Conditions
- Irritable Bowel Syndrome
- Keywords
- well being
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 May 2026 (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 purpose of this randomized behavioral clinical trial is to examine whether a well-being intervention can improve both psychological well-being and physical outcomes in adults with Irritable Bowel Syndrome (IBS). The study aims to assess whether this intervention decreases anger, anxiety, and depression; increases self-esteem, empathy, and hope; and improves quality of life indicators such as IBS symptom severity, sleep quality, fatigue, and diet. Participants can expect to be on study for up to 9 months.
Detailed description
This study consists of two phases:
Study 1 (Screening and Baseline Assessment):
Participants who self-identify as having been diagnosed with IBS and receive care at the University of Wisconsin (UW) Digestive Health Center will complete a battery of self-report questionnaires assessing well-being, anger, anxiety, depression, self-esteem, empathy, hope, sleep quality, fatigue, diet, and IBS symptom severity.
Study 2 (Intervention Phase - registered here):
Eligible participants will be randomized to either an experimental well-being intervention or a waitlist control condition. Participants assigned to the waitlist control condition will not receive the intervention during the initial intervention period but will complete all scheduled assessments. After completion of the first post-test assessment, waitlist participants will receive the same 15-session well-being intervention (crossover design).
The intervention will be held once a week for 15 weeks, lasting approximately one hour per session, conducted in a private meeting room at the Digestive Health Center. Sessions focus on emotional awareness, perspective-taking, and developing the capacity to overcome hurt and resentment toward a person who acted unfairly.
Following completion, both groups will complete post-test and follow-up assessments identical to the baseline questionnaires. Qualitative interviews will be conducted to explore participants' experiences with the intervention.
[Note - so as not to bias participants, specific information about the intervention will be withheld until the study is complete]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Well-Being Intervention | Experimental | Behavioral: Well-Being Intervention |
| Waitlist Control (delayed Well-Being Intervention) | Active comparator | Behavioral: Well-Being Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women currently diagnosed with Irritable Bowel Syndrome (IBS) by a healthcare provider.
- Able to read and write in English.
- Willing to complete questionnaires and participate in either the intervention or control group.
- Capable of providing informed consent.
- Must be a UW Health patient or referred through UW Digestive Health Center.
Key exclusion criteria (4 listed)
- Individuals with cognitive impairments or reading difficulties that would interfere with understanding study materials or completing assessments.
- Individuals unable to provide informed consent.
- Prior participation in a similar intervention study.
- Non-English speakers (since study materials are in English)
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 |
|---|---|---|
| Well-Being InterventionThe intervention will be once weekly over a 15-week period, lasting approximately one hour per session. | Behavioural | Waitlist Control (delayed Well-Being Intervention), Well-Being Intervention |
Primary outcome
Anger measured by PROMIS Anger Scale Score
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anger Scale is scored from 5-25 where higher scores indicates more anger.
Anxiety measured by PROMIS Anxiety Scale Score
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The PROMIS Anxiety Scale is scored from 7-35 where higher scores indicates more anxiety.
Depression measured by IBS PROMIS Depression Scale Score
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The IBS PROMIS Depression Scale is scored from 8-40 where higher scores indicates more depression.
Fatigue measured by IBS Fatigue 8a Score
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The IBS Fatigue 8a Scale is scored from 8-40 where higher scores indicates more fatigue.
Sleep Disturbance measured by IBS Sleep Disturbance 8b
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The IBS Sleep Disturbance 8b Scale is scored from 8-40 where higher scores indicates more sleep disturbance.
Pain measured by Item 1b of the IBS Symptom Severity Scale
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
This item is scored from 0-100 where higher scores indicates increased pain.
IBS Severity Score measured by IBS Symptom Severity Scale
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The IBS Symptom Severity Scale is scored from 0-100 where higher scores indicates more severe IBS symptoms.
Well-Being measured by a 30 item Inventory
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The inventory is scored from 30-180 where higher scores indicates greater level of well-being.
Self-esteem measured by Rosenberg Self Esteem Scale Score
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The Rosenberg Self Esteem Scale is scored from 0-30 where higher scores indicates higher self esteem.
Empathy measured by Empathy Questionnaire
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The Empathy Questionnaire is scored from 0-64 where higher scores indicates higher empathy.
Hope measured by Heart Hope Index Score
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The Heart Hope Index is scored from 12-48 where higher scores indicates greater hope.
Healthy Diet Pattern measured by an IBS Diet Survey
Time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)
The Diet Survey is scored from 5-24 where higher scores indicate healthier diet pattern.
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Mark Benson, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-Being Intervention in people with Irritable Bowel Syndrome, run by University of Wisconsin, Madison 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 Sep 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?
Contact Mark Benson, MD (608-263-1995, mb4@medicine.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anger measured by PROMIS Anger Scale Score (time frame: Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study)). The study lists 12 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 29 Sep 2026.