Irritable Bowel Syndrome
Conditions
Keywords
well being
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.
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. \[Note - so as not to bias participants, specific information about the intervention will be withheld until the study is complete\]
Interventions
BEHAVIORALWell-Being Intervention
The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anger measured by PROMIS Anger Scale Score | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Anger Scale is scored from 5-25 where higher scores indicates more anger. |
| Anxiety measured by PROMIS Anxiety Scale Score | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The PROMIS Anxiety Scale is scored from 7-35 where higher scores indicates more anxiety. |
| Depression measured by IBS PROMIS Depression Scale Score | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The IBS PROMIS Depression Scale is scored from 8-40 where higher scores indicates more depression. |
| Fatigue measured by IBS Fatigue 8a Score | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The IBS Fatigue 8a Scale is scored from 8-40 where higher scores indicates more fatigue. |
| Sleep Disturbance measured by IBS Sleep Disturbance 8b | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The IBS Sleep Disturbance 8b Scale is scored from 8-40 where higher scores indicates more sleep disturbance. |
| Pain measured by Item 1b of the IBS Symptom Severity Scale | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | This item is scored from 0-100 where higher scores indicates increased pain. |
| IBS Severity Score measured by IBS Symptom Severity Scale | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The IBS Symptom Severity Scale is scored from 0-100 where higher scores indicates more severe IBS symptoms. |
| Well-Being measured by a 30 item Inventory | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The inventory is scored from 30-180 where higher scores indicates greater level of well-being. |
| Self-esteem measured by Rosenberg Self Esteem Scale Score | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The Rosenberg Self Esteem Scale is scored from 0-30 where higher scores indicates higher self esteem. |
| Empathy measured by Empathy Questionnaire | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The Empathy Questionnaire is scored from 0-64 where higher scores indicates higher empathy. |
| Hope measured by Heart Hope Index Score | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The Heart Hope Index is scored from 12-48 where higher scores indicates greater hope. |
| Healthy Diet Pattern measured by an IBS Diet Survey | Data will be collected up to 17 weeks and will include a 4-and 12-week post-intervention assessment for both the waitlist-control and intervention groups (intervention group up to 29 weeks on study and the waitlist-control group up to 46 weeks on study) | The Diet Survey is scored from 5-24 where higher scores indicate healthier diet pattern. |
Countries
United States
Contacts
CONTACTMark Benson, MD
PRINCIPAL_INVESTIGATORMark Benson, MD
UW School of Medicine and Public Health
Outcome results
None listed