Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Approved 4/2/26 | Other Identifier | UW Madison | |
| SMPH/DOM/Gastroent and Hepato | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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]
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Well-Being Intervention | Experimental |
| |
| Waitlist Control (delayed Well-Being Intervention) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Well-Being Intervention | Behavioral | The intervention will be once weekly over a 15-week period, lasting approximately one hour per session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Benson, MD | Contact | 608-263-1995 | mb4@medicine.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark Benson, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Health Digestive Health Center | Madison | Wisconsin | 53705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D004066 | Digestive System Diseases |