WISH 2.0: Strengths and Happiness program for people with IBS
The WISH Intervention for IBS: Feasibility, Preliminary Effects, and Candidate Gut-Brain Mechanisms
This trial will test a positive psychology program to see if it improves well-being and gut symptoms in adults with IBS compared with an educational program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06866106 on ClinicalTrials.gov |
What this trial studies
WISH 2.0 randomizes adults who meet Rome IV criteria for IBS to an optimized positive psychology (PP) intervention or an educational control to examine feasibility, acceptability, and preliminary effects. The PP program is designed for scalable, remote delivery using structured exercises to boost positive psychological well-being, while the control provides education about IBS. Outcomes include patient-reported well-being, IBS symptoms, health-related quality of life, and candidate gut–brain mechanism measures, along with feasibility and acceptability metrics. Key exclusions include inflammatory bowel disease, severe psychiatric illness, cognitive impairment, and certain cardiac conditions or medications.
Who should consider this trial
Good fit: Adults with IBS who meet Rome IV diagnostic criteria, speak English, have phone access, and do not have IBD, severe psychiatric illness, cognitive impairment, or disqualifying cardiac issues are ideal candidates.
Not a fit: Patients whose symptoms are better explained by inflammatory bowel disease or other structural GI disease, those with severe unmanaged psychiatric illness or cognitive impairment, or those unable to participate remotely or who plan to start other psychotherapy are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could improve well-being, reduce IBS symptoms, and provide a scalable, low-burden behavioral option for people with IBS.
How similar studies have performed: Positive psychology interventions have produced benefits in other chronic medical conditions, but aside from preliminary proof-of-concept work by the investigators, PP has not been tested in IBS.
Eligibility criteria
Show full inclusion / exclusion 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: * 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth N Madva, MD — Massachusetts General Hospital
- Study coordinator: Elizabeth N Madva, MD
- Email: emadva@mgh.harvard.edu
- Phone: 617-724-6300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.