A Well-Being Intervention for People With IBS

NCT07600047 | Not Yet Recruiting

• 3 other identifiers: 2025-1538Protocol Approved 4/2/26SMPH/DOM/Gastroent and Hepato
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Irritable Bowel Syndrome

Keywords

well being

Outcome Measures

Primary Outcomes (12)

• Anger measured by PROMIS Anger Scale Score

  The 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

• 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

Study Arms (2)

Well-Being Intervention

EXPERIMENTAL

Behavioral: Well-Being Intervention

Waitlist Control (delayed Well-Being Intervention)

ACTIVE COMPARATOR

Behavioral: Well-Being Intervention

Interventions

Well-Being Intervention BEHAVIORAL

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

Waitlist Control (delayed Well-Being Intervention); Well-Being Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Health Digestive Health Center

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mark Benson, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Benson, MD

CONTACT

608-263-1995; mb4@medicine.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)