A Well-Being Intervention for People With IBS
9. september 2026 opdateret af: University of Wisconsin, Madison
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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]
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
150
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mark Benson, MD
- Telefonnummer: 608-263-1995
- E-mail: mb4@medicine.wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53705
- UW Health Digestive Health Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Well-Being Intervention
|
The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.
|
|
Aktiv komparator: Waitlist Control (delayed Well-Being Intervention)
|
The intervention will be once weekly over a 15-week period, lasting approximately one hour per session.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anger measured by PROMIS Anger Scale Score
Tidsramme: 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.
|
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)
|
|
Anxiety measured by PROMIS Anxiety Scale Score
Tidsramme: 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.
|
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)
|
|
Depression measured by IBS PROMIS Depression Scale Score
Tidsramme: 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.
|
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)
|
|
Fatigue measured by IBS Fatigue 8a Score
Tidsramme: 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.
|
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)
|
|
Sleep Disturbance measured by IBS Sleep Disturbance 8b
Tidsramme: 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.
|
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)
|
|
Pain measured by Item 1b of the IBS Symptom Severity Scale
Tidsramme: 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.
|
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)
|
|
IBS Severity Score measured by IBS Symptom Severity Scale
Tidsramme: 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.
|
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)
|
|
Well-Being measured by a 30 item Inventory
Tidsramme: 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.
|
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)
|
|
Self-esteem measured by Rosenberg Self Esteem Scale Score
Tidsramme: 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.
|
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)
|
|
Empathy measured by Empathy Questionnaire
Tidsramme: 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.
|
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)
|
|
Hope measured by Heart Hope Index Score
Tidsramme: 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.
|
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)
|
|
Healthy Diet Pattern measured by an IBS Diet Survey
Tidsramme: 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.
|
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Mark Benson, MD, UW School of Medicine and Public Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. august 2027
Studieafslutning (Anslået)
1. august 2027
Datoer for studieregistrering
Først indsendt
13. maj 2026
Først indsendt, der opfyldte QC-kriterier
13. maj 2026
Først opslået (Faktiske)
20. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-1538
- SMPH/DOM/Gastroent and Hepato (Anden identifikator: UW Madison)
- Protocol Approved 9/2/26 (Anden identifikator: UW Madison)
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