Well-Being Intervention for Irritable Bowel Syndrome (IBS)

This study is testing a "Well-Being Intervention" to see if it can help adults with Irritable Bowel Syndrome (IBS). The goal is to improve both emotional well-being and physical symptoms. Researchers want to see if this intervention can reduce anger, anxiety, and depression, and improve self-esteem, empathy, hope, and quality of life. This includes looking at IBS symptom severity, sleep, fatigue, and diet. You can join if you have an IBS diagnosis, can read English, are willing to complete questionnaires, and are a UW Health patient or referred by the UW Digestive Health Center. The study aims to enroll 150 participants.

Study design
This is an interventional study that will enroll 150 participants. It is a randomized trial where you might receive the intervention right away or after a waiting period.
What's involved
You will participate in a 15-week intervention with one-hour sessions weekly, and complete questionnaires. You can expect to be in the study for up to 9 months.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for 4 weeks after the intervention period, with data collected up to 21 or 38 weeks depending on your group.

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NCT07600047

A Well-Being Intervention for People With IBS

Not Yet Recruiting
NAAges 18+InterventionalTreatment
University of Wisconsin, Madison
~150 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Well-Being Intervention

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Anger measured by PROMIS Anger Scale Score
Measured over data collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group
+11 more outcomes measured
Irritable Bowel Syndrome
1 sites across 1 states
Wisconsin1
  • Mark Benson, MD · PRINCIPAL_INVESTIGATOR · UW School of Medicine and Public Health

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Eligibility criteria

Inclusion

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.

Exclusion

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)
  • Anger measured by PROMIS Anger Scale Scoredata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    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 Scoredata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    The PROMIS Anxiety Scale is scored from 7-35 where higher scores indicates more anxiety.

  • Depression measured by IBS PROMIS Depression Scale Scoredata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    The IBS PROMIS Depression Scale is scored from 8-40 where higher scores indicates more depression.

  • Fatigue measured by IBS Fatigue 8a Scoredata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    The IBS Fatigue 8a Scale is scored from 8-40 where higher scores indicates more fatigue.

  • Sleep Disturbance measured by IBS Sleep Disturbance 8bdata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    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 Scaledata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    This item is scored from 0-100 where higher scores indicates increased pain.

  • IBS Severity Score measured by IBS Symptom Severity Scaledata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    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 Inventorydata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    The inventory is scored from 30-180 where higher scores indicates greater level of well-being.

  • Self-esteem measured by Rosenberg Self Esteem Scale Scoredata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    The Rosenberg Self Esteem Scale is scored from 0-30 where higher scores indicates higher self esteem.

  • Empathy measured by Empathy Questionnairedata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    The Empathy Questionnaire is scored from 0-64 where higher scores indicates higher empathy.

  • Hope measured by Heart Hope Index Scoredata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    The Heart Hope Index is scored from 12-48 where higher scores indicates greater hope.

  • Healthy Diet Pattern measured by an IBS Diet Surveydata collected up to 17 weeks with a 4 week follow up at 21 weeks on study for the first intervention and waitlist-control, data collected up to 34 weeks with a 4 week follow up at 38 weeks on study to complete data collection in the crossover group

    The Diet Survey is scored from 5-24 where higher scores indicate healthier diet pattern.