Irritable Bowel SyndromeNCT06866106
Well-being in IBS: Strengths and Happiness (WISH) 2.0
A study testing Positive Psychology (PP) Intervention and Educational Intervention in people with Irritable Bowel Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Positive Psychology (PP) Intervention and Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Elizabeth N Madva, MD, 617-724-6300 ext. 111-134-2334, emadva@mgh.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Positive Psychology (PP) Intervention, Educational Intervention
- Keywords
- irritable bowel syndrome, brain-gut behavior therapy, behavioral health intervention, psychological intervention, psychotherapy
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Psychology (PP) InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology (PP) Intervention | Experimental | Participants will complete an adapted, optimized, phone-based, 9-week positive psychology (PP) intervention. Receives: Behavioral: Positive Psychology (PP) Intervention |
| Educational Intervention | Active comparator | Participants will complete a 9-week, phone-based educational intervention that matches the PP intervention in terms of both time and attention. Receives: Behavioral: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Weekly during intervention (weeks 1-8) and post-intervention (week 9)
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: Weeks 1-9
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.
Measured: 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.
Measured: 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.
Measured: At prescreening (prior to baseline), 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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 Autonomic Function
Heart-rate variability measurements will be collected to explore changes in autonomic function related to the intervention.
Measured: At baseline (week 1) and post-intervention (week 9)
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.
Measured: At baseline (week 1) and post-intervention (week 9)
Change in Blood Inflammatory Biomarker Levels
Blood inflammatory biomarker levels will be assessed to explore changes in immune system activity related to the intervention.
Measured: 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.
Measured: 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.
Measured: Week 1 (after first phone session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start30 Oct 2025
- Primary completionApr 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing positive psychology (PP) intervention to educational intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth N. Madva, M.D., Massachusetts General Hospital
- Investigators
- Elizabeth N Madva, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866106
- Sponsor's protocol ID
- 2025P000594
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Madva EN, Huffman JC, Burton-Murray H, McGranaghan E, Bidgood M, Gan JY, Wasserman B, Feig EH, Healy B, Staller K, Reed B, Sclocco R, Amr SS, Bartels S, Kuo B, Keefer L, Celano CM. The WISH 2.0 Intervention for Irritable Bowel Syndrome: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 23;15:e98352. doi: 10.2196/98352.
PubMed 42492091
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WISH Intervention for IBS: Feasibility, Preliminary Effects, and Candidate Gut-Brain Mechanisms
- ClinicalTrials.gov ID
- NCT06866106
- Acronym / sponsor ID
- 2025P000594
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, brain-gut behavior therapy, behavioral health intervention, psychological intervention, psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial comparing positive psychology (PP) intervention to educational intervention
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology (PP) Intervention | Experimental | Behavioral: Positive Psychology (PP) InterventionParticipants will complete an adapted, optimized, phone-based, 9-week positive psychology (PP) intervention. |
| Educational Intervention | Active comparator | Behavioral: Educational InterventionParticipants will complete a 9-week, phone-based educational intervention that matches the PP intervention in terms of both time and attention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IBS Diagnosis: Adult patients with an IBS diagnosis meeting standardized Rome IV diagnostic criteria.
- Language and communication: English fluency and access to a phone.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Psychology (PP) InterventionThis 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. | Behavioural | Positive Psychology (PP) Intervention |
| Educational InterventionThis 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. | Behavioural | Educational Intervention |
Primary outcome
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.
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).
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).
24 secondary outcomes
Immediate Impact of the Exercises: Change in Optimism Ratings
Time frame: Weeks 1-9
Immediate Impact of the Exercises: Change in Happiness Ratings
Time frame: Weeks 1-9
Immediate Impact of the Exercises: Change in IBS Knowledge Ratings
Time frame: Weeks 1-9
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Change in Autonomic Function
Time frame: At baseline (week 1) and post-intervention (week 9)
Change in Stress-Mediated Gene Expression
Time frame: At baseline (week 1) and post-intervention (week 9)
Change in Blood Inflammatory Biomarker Levels
Time frame: At baseline (week 1) and post-intervention (week 9)
Treatment Credibility
Time frame: Week 1 (after first phone session)
Treatment Expectancy
Time frame: Week 1 (after first phone session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Derived from this study: PubMed 42492091Madva EN, Huffman JC, Burton-Murray H, McGranaghan E, Bidgood M, Gan JY, Wasserman B, Feig EH, Healy B, Staller K, Reed B, Sclocco R, Amr SS, Bartels S, Kuo B, Keefer L, Celano CM. The WISH 2.0 Intervention for Irritable Bowel Syndrome: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 23;15:e98352. doi: 10.2196/98352.
- Individual participant dataSharing planned: Yes. 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.
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth N Madva, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychology (PP) Intervention and Educational Intervention in people with Irritable Bowel Syndrome, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth N Madva, MD (617-724-6300 ext. 111-134-2334, emadva@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Intervention Sessions Completed by Participants (time frame: Post-intervention at 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06866106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.