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

NCT ID: NCT06866106

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2028-08-31

Brief Summary

The purpose of this study is to examine the feasibility, acceptability, preliminary effects, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled "WISH," compared to an educational control intervention.

Detailed Description

Irritable bowel syndrome (IBS), a disorder of gut-brain interaction (DGBI; also known as functional gastrointestinal (GI) disorder) is characterized by abdominal pain and altered bowel habits, and conceptualized as resulting from complex interactions between biological, psychological, and social factors. Compared to healthy populations, individuals with IBS have reduced positive psychological well-being, which in turn has been associated with impaired physical health, greater depression and anxiety, and worse health-related quality of life. A growing body of evidence supports the use of behavioral health interventions, referred to as brain-gut behavior therapies (BGBTs), as part of a comprehensive treatment approach for IBS. There is a critical need for new BGBTs for IBS that are scalable, acceptable, and mechanistically targeted.

Positive psychology (PP) interventions have successfully been implemented in a variety of other chronic medical conditions to improve well-being, health-related quality of life, health behavior engagement, and health outcomes. PP interventions are typically highly acceptable and easily delivered remotely without extensive specialized training, which increases their scalability and reach. Aside from the investigator's preliminary proof-of-concept work, however, PP interventions have not been evaluated in IBS.

Accordingly, the purpose of this study is to examine the feasibility, acceptability, preliminary efficacy, and candidate gut-brain mechanisms of an optimized, 9-week, phone-delivered, PP intervention for patients with IBS, entitled "Well-being in IBS: Strengths and Happiness (WISH)," compared to a time-and attention-matched educational control intervention.

The primary aims of this randomized controlled trial (RCT) are to determine feasibility (at least 50% of participants completing at least 6/9 PP sessions) and acceptability (mean ease and utility ratings for each session of at least 7/10).

The exploratory aims of this RCT are to examine: (1) preliminary effects of the PP intervention in improving health-related (IBS symptom severity, health-related quality of life, and IBS diagnostic criteria), psychological (positive affect, optimism, resilience, self-efficacy, depression, anxiety, GI symptom-specific anxiety, response to pain, and perceived stress), and health behavior (physical activity, avoidant/restrictive eating) outcomes; and (2) candidate gut-brain mechanisms of the PP intervention including changes in autonomic function (as measured by heart-rate variability), interoception, stress-mediated gene expression, and immune system activity.

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; brain-gut behavior therapy; behavioral health intervention; psychological intervention; psychotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Positive Psychology (PP) Intervention

Participants will complete an adapted, optimized, phone-based, 9-week positive psychology (PP) intervention.

Group Type: EXPERIMENTAL

Positive Psychology (PP) Intervention

Intervention Type: BEHAVIORAL

This is an adapted, optimized, phone-based, 9-week positive psychology (PP) intervention. Participants will complete 9 weekly phone sessions (30 minutes each) with a study interventionist in which they will review PP exercises that they have independently completed in between phone sessions. The PP exercises will be completed in a treatment manual that describes the PP exercise and provides space to write about the exercise and its effects, and to answer associated questions. A total of 9 sessions will be completed over the course of the program.

Educational Intervention

Participants will complete a 9-week, phone-based educational intervention that matches the PP intervention in terms of both time and attention.

Group Type: ACTIVE_COMPARATOR

Educational Intervention

Intervention Type: BEHAVIORAL

This is an educational intervention that will match the PP intervention in terms of both time and attention. Participants will complete 9 weekly phone sessions (30 minutes each) with a study interventionist in which they will review educational exercises that they have independently completed in between phone sessions. The exercises will be completed in a treatment manual that describes the exercise and provides space to write about the exercise and its effects, and to answer associated questions. A total of 9 sessions will be completed over the course of the program.

Interventions

Positive Psychology (PP) Intervention

This is an adapted, optimized, phone-based, 9-week positive psychology (PP) intervention. Participants will complete 9 weekly phone sessions (30 minutes each) with a study interventionist in which they will review PP exercises that they have independently completed in between phone sessions. The PP exercises will be completed in a treatment manual that describes the PP exercise and provides space to write about the exercise and its effects, and to answer associated questions. A total of 9 sessions will be completed over the course of the program.

Intervention Type: BEHAVIORAL

Educational Intervention

This is an educational intervention that will match the PP intervention in terms of both time and attention. Participants will complete 9 weekly phone sessions (30 minutes each) with a study interventionist in which they will review educational exercises that they have independently completed in between phone sessions. The exercises will be completed in a treatment manual that describes the exercise and provides space to write about the exercise and its effects, and to answer associated questions. A total of 9 sessions will be completed over the course of the program.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• IBS Diagnosis: Adult patients with an IBS diagnosis meeting standardized Rome IV diagnostic criteria.
• Language and communication: English fluency and access to a phone.

Exclusion Criteria

• Severe psychiatric illness: Current manic episode, psychosis, or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI).
• Cognitive impairment: Assessed using a six-item cognitive screen developed for research.
• Presence of atrial fibrillation or a cardiac pacemaker, or daily use of beta blocking medication: As reported by the patient and/or documented in the medical record.
• Plans to start or participate in another new behavioral health intervention or psychotherapy during the study period.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth N. Madva, M.D.

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth N Madva, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth N Madva, MD

Role: CONTACT

Phone: 617-724-6300

Email: emadva@mgh.harvard.edu

Emmett McGranaghan, BS

Role: CONTACT

Phone: 617-643-4489

Email: emcgranaghan@mgb.org

Facility Contacts

Elizabeth N Madva, MD

Role: primary

Other Identifiers

2025P000594

Identifier Type: -

Identifier Source: org_study_id