RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Positive Psychology (PP) Intervention for Irritable Bowel Syndrome

This study wants 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.

Official registry: https://clinicaltrials.gov/study/NCT06866106 · Massachusetts General Hospital · enrollment listed as 50

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Positive Psychology (PP) Intervention, or Educational Intervention. The registry lists allocation as randomized. This study wants 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.

They plan to enroll about 50 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

The WISH Intervention for IBS: Feasibility, Preliminary Effects, and Candidate Gut-Brain Mechanisms

Interventions: Positive Psychology (PP) Intervention, Educational Intervention

Primary outcome (registry wording): Proportion of Intervention Sessions Completed by Participants

Who it is for (from inclusion criteria)

Ages 18 Years to any
IBS Diagnosis: Adult patients with an IBS diagnosis meeting standardized Rome IV diagnostic criteria
Language and communication: English fluency and access to a phone

Who the registry excludes

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) or Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
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

Public study contact (from the registry)

Elizabeth N Madva, MD

617-724-6300

emadva@mgh.harvard.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Massachusetts General Hospital — Boston, Massachusetts (recruiting)

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FAQ about this NCT record

Is NCT06866106 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06866106?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06866106?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary