Well-Being Intervention for Irritable Bowel Syndrome

MB
Overseen ByMark Benson, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a well-being intervention, a therapy focused on mental and physical health, can improve the mental and physical well-being of people with Irritable Bowel Syndrome (IBS). The intervention aims to reduce anger, anxiety, and depression while enhancing self-esteem, empathy, and hope. It also seeks to improve IBS symptoms, sleep, fatigue, and diet. Participants must have an IBS diagnosis and be able to read and write in English. UW Health patients or those referred through their Digestive Health Center may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance well-being for IBS patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this well-being intervention is safe for adults with IBS?

Research has shown that treatments focused on well-being for people with Irritable Bowel Syndrome (IBS) are safe. Studies examining various non-drug methods for managing IBS have found them effective and safe. These treatments aim to reduce symptoms like anxiety and depression, common in people with IBS.

Evidence also indicates that digital health tools can enhance the quality of life for IBS patients. These tools have produced positive results without major safety issues. Overall, improving mental well-being has a safe track record in treating IBS.12345

Why are researchers excited about this trial?

Most treatments for irritable bowel syndrome (IBS), like dietary changes, fiber supplements, and medications to ease symptoms, focus on managing physical aspects of the condition. But the Well-Being Intervention takes a different approach by addressing the psychological and emotional aspects that can influence IBS. Researchers are excited about this treatment because it aims to improve patients' overall quality of life by integrating mental wellness with physical health, potentially offering relief without the side effects associated with traditional medications. This holistic approach could redefine how we manage IBS, making the mind-body connection a central part of treatment.

What evidence suggests that this well-being intervention is effective for IBS?

This trial will evaluate a Well-Being Intervention for Irritable Bowel Syndrome (IBS). Research has shown that various well-being activities can ease IBS symptoms. For example, exercise programs have improved IBS symptoms and enhanced the quality of life for those affected. Additionally, digital health tools have successfully reduced IBS symptoms and improved quality of life. Psychological treatments have also proven helpful, boosting mental well-being and reducing anxiety and depression related to IBS. Overall, these activities can lead to better physical and emotional health for people with IBS.678910

Who Is on the Research Team?

MB

Mark Benson, MD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Irritable Bowel Syndrome (IBS) who can read and write in English, are willing to fill out questionnaires, and are patients or referrals at UW Health. Participants must be able to give informed consent.

Inclusion Criteria

* Able to read and write in English.
I am willing to fill out questionnaires and join any study group assigned.
* Must be a UW Health patient or referred through UW Digestive Health Center.
See 2 more

Timeline for a Trial Participant

Screening and Baseline Assessment

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Intervention

Participants receive a well-being intervention once a week for 15 weeks, focusing on emotional awareness, perspective-taking, and overcoming hurt and resentment.

15 weeks
15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with post-test and follow-up assessments identical to baseline questionnaires.

4 weeks
2 visits (in-person)

Crossover Intervention

Waitlist control participants receive the same 15-session well-being intervention after the initial intervention period.

15 weeks
15 visits (in-person)

Follow-up for Crossover Group

Crossover group participants are monitored for safety and effectiveness after their intervention, with follow-up assessments.

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Well-Being Intervention

Trial Overview

The study tests a well-being intervention designed to improve mental health and IBS symptoms compared to usual care. Participants are randomly assigned to either the intervention or control group for up to 9 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Well-Being InterventionExperimental Treatment1 Intervention
Group II: Waitlist Control (delayed Well-Being Intervention)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Citations

The effects of different exercise interventions on clinical ... - PMC

Various exercise interventions may improve clinical symptoms and quality of life in patients with irritable bowel syndrome to a certain extent, and may possess ...

Outcome measures for irritable bowel syndrome - PMC - NIH

Abdominal pain and distension were most frequently measured using 11-point scales, while stool consistency was primarily assessed via the Bristol Stool Form ...

Efficacy of dietary interventions in irritable bowel syndrome

In terms of dietary interventions for IBS, the most evidence exists for a low FODMAP diet, which was superior to a habitual diet for almost all symptom ...

Efficacy of dietary interventions in irritable bowel syndrome

Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial.

Types and Outcomes of Dietary Interventions in IBS

The most common primary outcomes were the effect on IBS symptoms (n = 48), efficacy in terms of improving quality of life (n = 10), psychological well-being (n ...

Well-being in IBS: Strengths and Happiness (WISH) 2.0

Compared to healthy populations, individuals with IBS have reduced positive psychological well-being, which in turn has been associated with impaired physical ...

Efficacy and safety of non-pharmacological interventions for ...

This study confirmed the efficacy and safety of NPIs for improving IBS symptoms, which to some extent recommended several interventions for ...

Well-being in IBS: Strengths and Happiness (WISH)

The purpose of this pilot study is to examine the feasibility, acceptability, and preliminary efficacy of a customized positive psychology (PP) intervention for ...

Digital Health Interventions Are Effective for Irritable Bowel ...

Findings from our review indicate that DHIs effectively improve IBS symptoms and QOL, which is consistent with reviews on IBD-focused DHIs that ...

A Well-Being Intervention for People With IBS

The study aims to assess whether this intervention decreases anger, anxiety, and depression; increases self-esteem, empathy, and hope; and ...