JMIR Publications

ABSTRACT

Background:

There is a critical need for acceptable, scalable, and mechanistically targeted behavioral health interventions for irritable bowel syndrome (IBS), known as brain-gut behavior therapies (BGBTs). Although positive psychology (PP) interventions, which focus on the cultivation of positive psychological well-being, have been linked to improved health outcomes across diverse medical populations, they have not yet been investigated in IBS. To address this gap, we developed WISH, a novel, 9-week, phone-delivered PP-based BGBT for individuals with IBS.

Objective:

This randomized controlled trial (RCT) aims to evaluate the feasibility, acceptability, preliminary effects, and candidate gut-brain mechanisms of a 9-week phone-delivered PP intervention for IBS compared to a time- and attention-matched educational control.

Methods:

The WISH 2.0 trial is a parallel-group, 9-week pilot RCT that aims to enroll 50 adults meeting Rome IV criteria for IBS. Participants are randomized (1:1), stratified by IBS subtype and gender, to either the WISH 2.0 intervention or an educational control condition. Both conditions consist of 9 weekly 30-minute phone sessions accompanied by weekly manualized exercises. Primary outcomes are feasibility (proportion completing ≥6/9 sessions) and acceptability (weekly ease and utility ratings). Secondary outcomes include WISH 2.0’s preliminary effects on health-related, health behavior, and psychological outcomes, assessed at four timepoints: baseline, intervention mid-point, post-intervention, and 3-months post-intervention. Candidate gut-brain mechanisms that might underly WISH 2.0’s effects, including changes in autonomic function (heart-rate variability), interoception (self-report measure), gene expression (whole transcriptome RNA sequencing), and immune system activity (serum inflammatory biomarkers), will be explored pre- and post-intervention.

Results:

The trial was approved by the Mass General Brigham Institutional Review Board and prospectively registered at ClinicalTrials.gov (NCT06866106). Recruitment began in October 2025 and is ongoing.

Conclusions:

This trial will determine the feasibility and acceptability of WISH 2.0, a novel PP intervention for IBS. Comparative results between WISH 2.0 and an educational control - including the possibility of equivalent outcomes - will provide important mechanistic insights and facilitate further optimization of BGBTs for IBS, informing a future fully powered efficacy trial. Clinical Trial: ClinicalTrials.gov NCT06866106; clinicaltrials.gov/study/NCT06866106