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

NCT06866106 | Recruiting DMC

• 1 other identifier: 2025P000594
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Proportion of Intervention Sessions Completed by Participants

  Feasibility will be measured by the proportion of intervention sessions completed by participants. The intervention will be considered feasible if at least 50% of participants complete at least 6/9 sessions.

  Post-intervention at 9 weeks

• Ease of Weekly Exercises

  Participants will provide ratings of ease after each weekly exercise, measured on a 10-point Likert scale (0=very difficult, 10=very easy).

  Weekly during intervention (weeks 1-8) and post-intervention (week 9)

• Utility of Weekly Exercises

  Participants will provide ratings of utility after each weekly exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful).

  Weekly during intervention (weeks 1-8) and post-intervention (week 9)

Secondary Outcomes (24)

• Immediate Impact of the Exercises: Change in Optimism Ratings

  Weeks 1-9

• Immediate Impact of the Exercises: Change in Happiness Ratings

  Weeks 1-9

• Immediate Impact of the Exercises: Change in IBS Knowledge Ratings

  Weeks 1-9

• Change in IBS Symptom Severity

  At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

• Change in IBS Health-Related Quality of Life

  At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

Study Arms (2)

Positive Psychology (PP) Intervention

EXPERIMENTAL

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

Behavioral: Positive Psychology (PP) Intervention

Educational Intervention

ACTIVE COMPARATOR

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

Behavioral: Educational Intervention

Interventions

Positive Psychology (PP) Intervention 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.

Positive Psychology (PP) Intervention

Educational Intervention 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.

Educational Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of inflammatory bowel disease or other structural/biochemical primary gastrointestinal illness that better explains IBS-like symptoms: As reported by the patient, their physician, and/or documented in the medical record.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Psychology, Positive; Methods; Early Intervention, Educational

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Psychology; Behavioral Sciences; Behavioral Disciplines and Activities; Investigative Techniques; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Elizabeth N Madva, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth N Madva, MD

CONTACT

617-724-6300; emadva@mgh.harvard.edu

Emmett McGranaghan, BS

CONTACT

617-643-4489; emcgranaghan@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: Randomized controlled trial comparing positive psychology (PP) intervention to educational intervention

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Datasets will be provided to respective repositories by the end of the funding period. The clinical data shared with the Vivli repository will be archived and available for request by researchers for a minimum of 10 years after contribution. Genomic data will be preserved in the dbGaP/SRA repositories for at least three years following the completion of the grant.
• Access Criteria: Clinical and genomic data will be shared with controlled access with the Vivli repository and dbGaP/SRA, respectively, for general research use, as allowed by the participants' informed consents and the Institutional Certification. Access to data requires the completion of a Data Use Agreement (DUA), which prohibits any redistribution or attempts to re-identify research participants.

Locations

US (1)