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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Well-Being Intervention

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Benson, MD; Phone Number: 608-263-1995; Email: mb4@medicine.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • UW Health Digestive Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Well-Being Intervention	Behavioral: Well-Being Intervention; The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.
Active Comparator: Waitlist Control (delayed Well-Being Intervention)	Behavioral: Well-Being Intervention; The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety measured by PROMIS Anxiety Scale Score	The PROMIS Anxiety Scale is scored from 7-35 where higher scores indicates more anxiety.	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
Depression measured by IBS PROMIS Depression Scale Score	The IBS PROMIS Depression Scale is scored from 8-40 where higher scores indicates more depression.	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
Fatigue measured by IBS Fatigue 8a Score	The IBS Fatigue 8a Scale is scored from 8-40 where higher scores indicates more fatigue.	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
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.	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
Pain measured by Item 1b of the IBS Symptom Severity Scale	This item is scored from 0-100 where higher scores indicates increased pain.	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
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.	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
Well-Being measured by a 30 item Inventory	The inventory is scored from 30-180 where higher scores indicates greater level of well-being.	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
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.	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
Empathy measured by Empathy Questionnaire	The Empathy Questionnaire is scored from 0-64 where higher scores indicates higher empathy.	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
Hope measured by Heart Hope Index Score	The Heart Hope Index is scored from 12-48 where higher scores indicates greater hope.	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
Healthy Diet Pattern measured by an IBS Diet Survey	The Diet Survey is scored from 5-24 where higher scores indicate healthier diet pattern.	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
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.	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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Mark Benson, MD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: well being
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: 2025-1538; Protocol Approved 4/2/26 (Other Identifier: UW Madison); SMPH/DOM/Gastroent and Hepato (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No