Recruiting

PP vs. Educational Control

Sponsor:

Massachusetts General Hospital

Code:

NCT06866106

Conditions

Irritable Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Positive Psychology (PP) Intervention

Educational Intervention

Study Details

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

Study ID

NCT06866106

Start date

Oct 30, 2025

Status verified date

Jun, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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) 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Positive Psychology (PP) Intervention

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

active comparator: Educational Intervention

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

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.

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.

Primary outcome measure

  • Proportion of Intervention Sessions Completed by Participants [ Time Frame: Post-intervention at 9 weeks ]
  • Ease of Weekly Exercises [ Time Frame: Weekly during intervention (weeks 1-8) and post-intervention (week 9) ]
  • Utility of Weekly Exercises [ Time Frame: Weekly during intervention (weeks 1-8) and post-intervention (week 9) ]

Central Contacts and Locations

Central contacts

Elizabeth N Madva, MD

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

Emmett McGranaghan, BS

617-643-4489emcgranaghan@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Elizabeth N Madva, MD

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

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-22.