A Well-Being Intervention for People With IBS

University of Wisconsin (UW)

Status

Begins enrollment in 2 months

Conditions

Irritable Bowel Syndrome

Treatments

Behavioral: Well-Being Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07600047

Protocol Approved 9/2/26 (Other Identifier)

2025-1538

SMPH/DOM/Gastroent and Hepato (Other Identifier)

Details and patient eligibility

About

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.

Full 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]

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)