Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07600047

A Well-Being Intervention for People With IBS

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW Health Digestive Health Center

Madison, Wisconsin, 53705, United States

About this study

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]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

Well-Being Intervention

Behavioral

The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.

Primary outcomes

  1. Anger measured by PROMIS Anger Scale Score

    Time frame: 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

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Anger Scale is scored from 5-25 where higher scores indicates more anger.

  2. Anxiety measured by PROMIS Anxiety Scale Score

    Time frame: 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

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

  3. Depression measured by IBS PROMIS Depression Scale Score

    Time frame: 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

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

  4. Fatigue measured by IBS Fatigue 8a Score

    Time frame: 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

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

  5. Sleep Disturbance measured by IBS Sleep Disturbance 8b

    Time frame: 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

    The IBS Sleep Disturbance 8b Scale is scored from 8-40 where higher scores indicates more sleep disturbance.

  6. Pain measured by Item 1b of the IBS Symptom Severity Scale

    Time frame: 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

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

  7. IBS Severity Score measured by IBS Symptom Severity Scale

    Time frame: 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

    The IBS Symptom Severity Scale is scored from 0-100 where higher scores indicates more severe IBS symptoms.

  8. Well-Being measured by a 30 item Inventory

    Time frame: 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

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

  9. Self-esteem measured by Rosenberg Self Esteem Scale Score

    Time frame: 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

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

  10. Empathy measured by Empathy Questionnaire

    Time frame: 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

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

  11. Hope measured by Heart Hope Index Score

    Time frame: 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

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

  12. Healthy Diet Pattern measured by an IBS Diet Survey

    Time frame: 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Benson, MD

CONTACT

[email protected]

608-263-1995

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.