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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Positive Psychology (PP) Intervention; Behavioral: Educational Intervention

Detailed Description

Irritable bowel syndrome (IBS), a disorder of gut-brain interaction (DGBI; also known as functional gastrointestinal (GI) disorder) is characterized by abdominal pain and altered bowel habits, and conceptualized as resulting from complex interactions between biological, psychological, and social factors. Compared to healthy populations, individuals with IBS have reduced positive psychological well-being, which in turn has been associated with impaired physical health, greater depression and anxiety, and worse health-related quality of life. A growing body of evidence supports the use of behavioral health interventions, referred to as brain-gut behavior therapies (BGBTs), as part of a comprehensive treatment approach for IBS. There is a critical need for new BGBTs for IBS that are scalable, acceptable, and mechanistically targeted.

Positive psychology (PP) interventions have successfully been implemented in a variety of other chronic medical conditions to improve well-being, health-related quality of life, health behavior engagement, and health outcomes. PP interventions are typically highly acceptable and easily delivered remotely without extensive specialized training, which increases their scalability and reach. Aside from the investigator's preliminary proof-of-concept work, however, PP interventions have not been evaluated in IBS.

Accordingly, the purpose of this study is to examine the feasibility, acceptability, preliminary efficacy, and candidate gut-brain mechanisms of an optimized, 9-week, phone-delivered, PP intervention for patients with IBS, entitled "Well-being in IBS: Strengths and Happiness (WISH)," compared to a time-and attention-matched educational control intervention.

The primary aims of this randomized controlled trial (RCT) are to determine feasibility (at least 50% of participants completing at least 6/9 PP sessions) and acceptability (mean ease and utility ratings for each session of at least 7/10).

The exploratory aims of this RCT are to examine: (1) preliminary effects of the PP intervention in improving health-related (IBS symptom severity, health-related quality of life, and IBS diagnostic criteria), psychological (positive affect, optimism, resilience, self-efficacy, depression, anxiety, GI symptom-specific anxiety, response to pain, and perceived stress), and health behavior (physical activity, avoidant/restrictive eating) outcomes; and (2) candidate gut-brain mechanisms of the PP intervention including changes in autonomic function (as measured by heart-rate variability), interoception, stress-mediated gene expression, and immune system activity.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth N Madva, MD; Phone Number: 111-134-2334 617-724-6300; Email: emadva@mgh.harvard.edu
• Study Contact Backup: Name: Emmett McGranaghan, BS; Phone Number: 617-643-4489; Email: emcgranaghan@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Elizabeth N Madva, MD; Phone Number: 111-134-2334 617-724-6300; Email: emadva@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Psychology (PP) Intervention; Participants will complete an adapted, optimized, phone-based, 9-week positive psychology (PP) intervention.	Behavioral: 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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IBS Symptom Severity	Measured by the IBS symptom severity score (IBS-SSS) (Range 0-500). This is a validated disease-specific instrument that measures IBS symptom severity. Higher scores indicate more severe symptoms.	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	Measured by the IBS Quality of Life (IBS-QOL) score (Range: 0-100), a validated disease-specific instrument measuring quality of life. Higher scores indicate better IBS-specific 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)
Change in Positive Affect	Measured with the positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses (Range: 10-50). Higher scores indicate higher levels of positive affect.	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 Resilience	Measured by the Brief Resilience Scale (BRS) (Range: 6-30), a reliable 6-item measure of the ability to "bounce back" or recover from stress. Higher scores reflect greater bounce back resilience.	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 Self-Efficacy	Measured by the General Self-Efficacy (GSE) Scale (Range: 10-40), a 10-item validated measure of self-efficacy, defined as an individual's perception of their ability to succeed at a task or achieve a goal. Higher scores indicate greater self-efficacy.	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 Depression	Measured by the Hospital Anxiety and Depression Scale (HADS)-depression subscale. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of depression.	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 Anxiety	Measured by the Hospital Anxiety and Depression Scale (HADS)-anxiety subscale. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety.	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 Gastrointestinal (GI) Symptom-Specific Anxiety	Measured by the Visceral Sensitivity Index (VSI) score, a validated self-report measure of anxiety specific to visceral sensations (Range: 0-75). Higher scores indicate higher levels of GI-specific anxiety.	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 Response to Pain	Measured by the Pain Catastrophizing Scale (PCS), a widely used tool to assess cognitive and affective responses to pain (Range: 0-52). Higher scores indicate higher levels of pain-related anxiety.	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 Perceived Stress	Measured by the Perceived Stress Scale (PSS) (Range: 0-40), a validated measure to assess perceived levels of stress. Higher scores indicate higher perceived stress.	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 Self-Reported Physical Activity	Measured by the self-report International Physical Activity Questionnaire (IPAQ) Short Form. This 7-item measure assesses self-reported physical activity from the preceding 7 days. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Higher scores reflect higher levels of physical activity.	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 Avoidant and Restrictive Eating	Measured by the Nine Item Avoidant/Restrictive Food Intake Disorder screen (NIAS) (Range: 0-45), a validated tool to assess avoidant/restrictive eating patterns. Higher scores indicate higher levels of avoidant/restrictive eating patterns.	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 Interoception	The Multidimensional Assessment of Interoceptive Awareness-Version 2 (MAIA-2) is a validated measure of interoception, defined as an awareness of internal bodily sensations (Range: 0-185). Higher scores indicate a higher level of interoceptive bodily awareness.	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 Stress-Mediated Gene Expression	Whole transcriptome analysis of blood samples by RNA sequencing (RNA-seq) will be completed to explore gene expression changes related to the intervention.	At baseline (week 1) and post-intervention (week 9)
Immediate Impact of the Exercises: Change in Optimism Ratings	Participants will provide ratings of optimism before and after each positive psychology exercise, measured on a 10-point Likert scale (0-10). Higher scores indicate higher levels of optimism.	Weeks 1-9
Immediate Impact of the Exercises: Change in Happiness Ratings	Participants will provide ratings of happiness before and after each positive psychology exercise, measured on a 10-point Likert scale (0-10). Higher scores indicate higher levels of happiness.	Weeks 1-9
Immediate Impact of the Exercises: Change in IBS Knowledge Ratings	Participants will provide ratings of knowledge about IBS before and after each educational exercise, measured on a 10-point Likert scale (0-10). Higher scores indicate higher levels of knowledge.	Weeks 1-9
Change in Autonomic Function	Heart-rate variability measurements will be collected to explore changes in autonomic function related to the intervention.	At baseline (week 1) and post-intervention (week 9)
Treatment Credibility	The Credibility sub-scale (Range: 3-27) of the Credibility/Expectancy Questionnaire (CEQ) will be used to compare treatment credibility between conditions. Higher scores indicate higher treatment credibility.	Week 1 (after first phone session)
Treatment Expectancy	The Expectancy sub-scale (Range: 3-27) of the Credibility/Expectancy Questionnaire (CEQ) will be used to compare treatment expectancy between conditions. Higher scores indicate higher treatment expectancy.	Week 1 (after first phone session)
Change in Dispositional Optimism	Measured with the Life Orientation Test-Revised (LOT-R), a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism.	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 State Optimism	Measured with the Brief State Optimism Measure (B-SOM), a validated 2-item instrument used to measure state optimism (Range: 0-100 for each item). Higher scores indicate greater state optimism.	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 Rome IV Diagnostic Criteria for IBS	Measured by the The Rome-IV Diagnostic Questionnaire - IBS Module, which is a validated disease-specific instrument used to screen for IBS diagnostic criteria and to provide a provisional (yes/no) diagnosis of IBS. To meet criteria for IBS, the following are required for the past 3 months: (1) recurrent abdominal pain at least weekly; (2) pain associated with 2 or more of the following criteria: a) related to defecation at least 30% of occasions; b) associated with change in stool frequency at least 30% of occasions; c) associated with change in stool form at least 30% of occasions; and (3) symptom onset at least 6 months prior to diagnosis.	At prescreening (prior to baseline), post-intervention (week 9), and 3-months post-intervention (week 21)
Change in Blood Inflammatory Biomarker Levels	Blood inflammatory biomarker levels will be assessed to explore changes in immune system activity related to the intervention.	At baseline (week 1) and post-intervention (week 9)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Elizabeth N Madva, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: psychotherapy; psychological intervention; irritable bowel syndrome; behavioral health intervention; brain-gut behavior therapy
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Investigative Techniques; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Behavioral Disciplines and Activities; Behavioral Sciences; Psychology; Methods; Early Intervention, Educational; Psychology, Positive
• Other Study ID Numbers: 2025P000594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

To help advance other research, de-identified data will be shared via respective repositories as specified below:

• Clinical data including demographics, self-report questionnaires, and heart-rate variability will be shared via the Vivli repository.
• Genomic data generated from RNA-seq will be submitted as FASTQ files to the Database of Genotypes and Phenotypes (dbGaP) which will then be shared to the Sequence Read Archive (SRA) with controlled access.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No