A Well-Being Intervention for People With IBS
ConditionIrritable Bowel Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Well-Being Intervention
BehavioralThe intervention will be once weekly over a 15-week period, lasting approximately one hour per session.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Well-Being InterventionExperimental treatment 1 intervention
Group B: Waitlist Control (delayed Well-Being Intervention)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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)2
Anxiety measured by PROMIS Anxiety Scale Score
The PROMIS Anxiety Scale is scored from 7-35 where higher scores indicates more anxiety.
Time frame
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)3
Depression measured by IBS PROMIS Depression Scale Score
The IBS PROMIS Depression Scale is scored from 8-40 where higher scores indicates more depression.
Time frame
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)4
Fatigue measured by IBS Fatigue 8a Score
The IBS Fatigue 8a Scale is scored from 8-40 where higher scores indicates more fatigue.
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: