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NCT Number: NCT06866106

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Elizabeth N Madva, MD

CONTACT

[email protected]

617-724-6300 ext. 111-134-2334

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive Psychology (PP) intervention

Behavioral

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

Behavioral

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 outcomes

  1. Proportion of Intervention Sessions Completed by Participants

    Time frame: Post-intervention at 9 weeks

    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.

  2. Ease of Weekly Exercises

    Time frame: Weekly during intervention (weeks 1-8) and post-intervention (week 9)

    Participants will provide ratings of ease after each weekly exercise, measured on a 10-point Likert scale (0=very difficult, 10=very easy).

  3. Utility of Weekly Exercises

    Time frame: Weekly during intervention (weeks 1-8) and post-intervention (week 9)

    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).

Secondary outcomes

  1. Immediate Impact of the Exercises: Change in Optimism Ratings

    Time frame: Weeks 1-9

    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.

  2. Immediate Impact of the Exercises: Change in Happiness Ratings

    Time frame: Weeks 1-9

    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.

  3. Immediate Impact of the Exercises: Change in IBS Knowledge Ratings

    Time frame: Weeks 1-9

    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.

  4. Change in IBS Symptom Severity

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  5. Change in IBS Health-Related Quality of Life

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  6. Change in Rome IV Diagnostic Criteria for IBS

    Time frame: At prescreening (prior to baseline), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  7. Change in Positive Affect

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  8. Change in Dispositional Optimism

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  9. Change in State Optimism

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  10. Change in Resilience

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  11. Change in Self-Efficacy

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  12. Change in Depression

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  13. Change in Anxiety

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  14. Change in Gastrointestinal (GI) Symptom-Specific Anxiety

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  15. Change in Response to Pain

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  16. Change in Perceived Stress

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  17. Change in Self-Reported Physical Activity

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  18. Change in Avoidant and Restrictive Eating

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  19. Change in Interoception

    Time frame: At baseline (week 1), at the mid-point of the intervention (week 5), post-intervention (week 9), and 3-months post-intervention (week 21)

    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.

  20. Change in Autonomic Function

    Time frame: At baseline (week 1) and post-intervention (week 9)

    Heart-rate variability measurements will be collected to explore changes in autonomic function related to the intervention.

  21. Change in Stress-Mediated Gene Expression

    Time frame: At baseline (week 1) and post-intervention (week 9)

    Whole transcriptome analysis of blood samples by RNA sequencing (RNA-seq) will be completed to explore gene expression changes related to the intervention.

  22. Change in Blood Inflammatory Biomarker Levels

    Time frame: At baseline (week 1) and post-intervention (week 9)

    Blood inflammatory biomarker levels will be assessed to explore changes in immune system activity related to the intervention.

  23. Treatment Credibility

    Time frame: Week 1 (after first phone session)

    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.

  24. Treatment Expectancy

    Time frame: Week 1 (after first phone session)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth N Madva, MD

CONTACT

[email protected]

617-724-6300 ext. 111-134-2334

Emmett McGranaghan, BS

CONTACT

[email protected]

617-643-4489

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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