Irritable Bowel SyndromeNCT05289089
Well-being in IBS: Strengths and Happiness (WISH)
A study testing Positive Psychology Intervention in people with Irritable Bowel Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this pilot study is to examine the feasibility, acceptability, and preliminary efficacy of a customized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS) compared to a wait list control group. 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 Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2022to 11 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 documented by the patient's primary care or GI clinician and meeting standardized ROME IV diagnostic criteria.
- Language and communication: English fluency and access to a telephone.
Who cannot join
- Severe psychiatric illness: Current manic episode, psychosis, or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI).
- Cognitive impairment: Assessed using a six-item cognitive screen developed for research.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Well-being in IBS: Strengths and Happiness (WISH) Pilot Trial
The purpose of this pilot study is to examine the feasibility, acceptability, and preliminary efficacy of a customized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS) compared to a wait list control group.
Read the detailed description
Irritable bowel syndrome (IBS), a disorder of gut-brain interaction (DGBI; formerly known as functional gastrointestinal disorder) is characterized by abdominal pain and altered bowel habits, and conceptualized as resulting from complex interactions between biological, psychological, and social factors.
The treatment approach for IBS is multifaceted and focused on symptom reduction rather than cure. For mild or infrequent symptoms, lifestyle modification (e.g., diet and exercise), reassurance, and education about the disorder can at times be sufficient. For moderate to severe symptoms, a combination of pharmacotherapy and behavioral health interventions is often required. A growing body of evidence supports the use of behavioral health interventions to target the gut-brain axis in DGBI - aptly referred to as brain-gut behavior therapies (BGBT). Though highly effective, existing BGBT for IBS face important limitations including scalability and acceptability. There is also limited focus among existing BGBT on the promotion of positive psychological (PP) constructs (e.g., optimism), which are deficient in IBS, associated with fewer IBS symptoms, and associated with lower levels of distress in both clinical and non-clinical populations.
PP interventions have successfully been implemented in a variety of other chronic medical conditions to improve well-being, health-related quality of life, and health behavior engagement. PP interventions are highly acceptable and easily delivered remotely without extensive specialized training, which increases their scalability and reach.
As such, the investigators plan to do the following in this project:
- Examine the feasibility and acceptability of a 9-week, telephone-delivered PP intervention adapted to the IBS population
- Explore the impact of the PP intervention on psychological, behavioral, and health-related outcomes, compared to a wait list control group.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Positive Psychology Intervention
- 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 InterventionBehavioural
Participants will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instruments and space to write about the exercise and its effects. Participants will independently complete PP exercises between phone sessions and review them with their study trainer during phone sessions. A total of 9 sessions will be completed over the course of the program.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology Intervention Group | Experimental | Participants will complete 9 weekly phone sessions with a study trainer and positive psychology exercises between phone sessions. Study trainers will review the positive psychology exercises with the participant on the phone each week. Participants will receive this intervention in addition to their treatment as usual. Receives: Behavioral: Positive Psychology Intervention |
| Wait list Control Group | Active comparator | After waiting for 9 weeks, participants will complete 9 weekly phone sessions with a study trainer and positive psychology exercises between phone sessions. Study trainers will review the positive psychology exercises with the participant on the phone each week. Participants will receive this intervention in addition to their treatment as usual. Receives: Behavioral: Positive Psychology Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of PP Sessions Completed by Participants
Measured by proportion of PP sessions completed by participants in each group.
Measured: 9 weeks
Secondary outcomes (21)
Ease of PP Exercises
Participants will provide ratings of ease after each PP exercise, measured on a 10-point Likert scale (0=very difficult, 10=very easy). Weekly ratings will be averaged to provide an overall ease of the exercises.
Measured: Weeks 1-9
Utility of PP exercises
Participants will provide ratings of utility after each PP exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings will be averaged to provide an overall utility score of the exercises.
Measured: Weeks 1-9
Change in Positive Affect
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, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Optimism
Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Depression
The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. 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. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Anxiety
The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. 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. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
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. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Ability to Bounce Back from Stress
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. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Ability to Cope with Stress and Adversity
Measured by the 25-item Connor-Davidson Resilience Scale (CD-RISC) (Range: 0-100), a reliable and validated measure of resilience, defined as the ability to cope with stress and adversity. Higher scores reflect greater resilience. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
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. Change will be calculated by subtracting the scores at baseline from the scores at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Perceived Stress
Measured by the Perceived Stress Scale (PSS) (Range: 0-40). Higher scores indicate higher perceived stress. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
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. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in IBS Symptom Severity
Measured by the IBS symptom severity score (IBS-SSS) score (Range: 0-500), a validated disease-specific instrument measuring symptom severity. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Self-Reported Physical Activity
Measured by the self-report International Physical Activity Questionnaire (IPAQ). This measure assesses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Adherence to a Physician-Recommended Diet
Measured with a single question inquiring if the participant followed the diet with possible responses including: never, a quarter of the time, half of the time, three-quarters of the time, or always. A score of 0-4 (0=never, 4=always) will be applied. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Adherence to Medications
Measured with a 3-item questionnaire from the Heart and Soul study. Participants will be categorized as adherent (>75% of the time) versus non-adherent (<75% of the time), and this will be compared between baseline and 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Avoidant and Restrictive Food Intake Disorder Symptoms
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. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in Eating Behaviors
Measured by the Eating Disorder Examination Questionnaire 8 (EDE-Q8) (Range: 0-6), an 8-item questionnaire that assesses eating disorder symptoms over the past 28 days. Higher scores indicate higher levels of eating disordered symptoms. Change will be calculated by subtracting the score at baseline from the score at 9 weeks.
Measured: Change in score from Baseline to 9 weeks
Change in IBS diagnostic criteria
Measured by the Rome IV Diagnostic Questionnaire - Irritable Bowel Syndrome (IBS) Module. This questionnaire provides inclusion criteria for IBS for clinical research studies. To meet criteria for IBS, participants must have the following 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: Change in score from Baseline to 9 weeks
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start25 Mar 2022
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 trial comparing PP intervention versus wait list control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Elizabeth N. Madva, M.D., Massachusetts General Hospital
- Investigators
- Elizabeth Madva, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289089
- Sponsor's protocol ID
- 2021P002996
- Status last verified
- Jun 2025
- First submitted
- 11 Mar 2022
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Well-being in IBS: Strengths and Happiness (WISH) Pilot Trial
- ClinicalTrials.gov ID
- NCT05289089
- Acronym / sponsor ID
- 2021P002996
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 21 Mar 2022 (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 pilot study is to examine the feasibility, acceptability, and preliminary efficacy of a customized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS) compared to a wait list control group.
Detailed description
Irritable bowel syndrome (IBS), a disorder of gut-brain interaction (DGBI; formerly known as functional gastrointestinal disorder) is characterized by abdominal pain and altered bowel habits, and conceptualized as resulting from complex interactions between biological, psychological, and social factors.
The treatment approach for IBS is multifaceted and focused on symptom reduction rather than cure. For mild or infrequent symptoms, lifestyle modification (e.g., diet and exercise), reassurance, and education about the disorder can at times be sufficient. For moderate to severe symptoms, a combination of pharmacotherapy and behavioral health interventions is often required. A growing body of evidence supports the use of behavioral health interventions to target the gut-brain axis in DGBI - aptly referred to as brain-gut behavior therapies (BGBT). Though highly effective, existing BGBT for IBS face important limitations including scalability and acceptability. There is also limited focus among existing BGBT on the promotion of positive psychological (PP) constructs (e.g., optimism), which are deficient in IBS, associated with fewer IBS symptoms, and associated with lower levels of distress in both clinical and non-clinical populations.
PP interventions have successfully been implemented in a variety of other chronic medical conditions to improve well-being, health-related quality of life, and health behavior engagement. PP interventions are highly acceptable and easily delivered remotely without extensive specialized training, which increases their scalability and reach.
As such, the investigators plan to do the following in this project:
- Examine the feasibility and acceptability of a 9-week, telephone-delivered PP intervention adapted to the IBS population
- Explore the impact of the PP intervention on psychological, behavioral, and health-related outcomes, compared to a wait list control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial comparing PP intervention versus wait list control
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology Intervention Group | Experimental | Behavioral: Positive Psychology InterventionParticipants will complete 9 weekly phone sessions with a study trainer and positive psychology exercises between phone sessions. Study trainers will review the positive psychology exercises with the participant on the phone each week. Participants will receive this intervention in addition to their treatment as usual. |
| Wait list Control Group | Active comparator | Behavioral: Positive Psychology InterventionAfter waiting for 9 weeks, participants will complete 9 weekly phone sessions with a study trainer and positive psychology exercises between phone sessions. Study trainers will review the positive psychology exercises with the participant on the phone each week. Participants will receive this intervention in addition to their treatment as usual. |
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 documented by the patient's primary care or GI clinician and meeting standardized ROME IV diagnostic criteria.
- Language and communication: English fluency and access to a telephone.
Key exclusion criteria (2 listed)
- Severe psychiatric illness: Current manic episode, psychosis, or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI).
- Cognitive impairment: Assessed using a six-item cognitive screen developed for research.
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 InterventionParticipants will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instruments and space to write about the exercise and its effects. Participants will independently complete PP exercises between phone sessions and review them with their study trainer during phone sessions. A total of 9 sessions will be completed over the course of the program. | Behavioural | Positive Psychology Intervention Group, Wait list Control Group |
Primary outcome
Proportion of PP Sessions Completed by Participants
Time frame: 9 weeks
Measured by proportion of PP sessions completed by participants in each group.
21 secondary outcomes
Ease of PP Exercises
Time frame: Weeks 1-9
Utility of PP exercises
Time frame: Weeks 1-9
Change in Positive Affect
Time frame: Change in score from Baseline to 9 weeks
Change in Optimism
Time frame: Change in score from Baseline to 9 weeks
Change in Depression
Time frame: Change in score from Baseline to 9 weeks
Change in Anxiety
Time frame: Change in score from Baseline to 9 weeks
Change in Gastrointestinal (GI) symptom specific anxiety
Time frame: Change in score from Baseline to 9 weeks
Change in Ability to Bounce Back from Stress
Time frame: Change in score from Baseline to 9 weeks
Change in Ability to Cope with Stress and Adversity
Time frame: Change in score from Baseline to 9 weeks
Change in Response to Pain
Time frame: Change in score from Baseline to 9 weeks
Change in Perceived Stress
Time frame: Change in score from Baseline to 9 weeks
Change in IBS Health-related Quality of Life
Time frame: Change in score from Baseline to 9 weeks
Change in IBS Symptom Severity
Time frame: Change in score from Baseline to 9 weeks
Change in Self-Reported Physical Activity
Time frame: Change in score from Baseline to 9 weeks
Change in Adherence to a Physician-Recommended Diet
Time frame: Change in score from Baseline to 9 weeks
Change in Adherence to Medications
Time frame: Change in score from Baseline to 9 weeks
Change in Avoidant and Restrictive Food Intake Disorder Symptoms
Time frame: Change in score from Baseline to 9 weeks
Change in Eating Behaviors
Time frame: Change in score from Baseline to 9 weeks
Change in IBS diagnostic criteria
Time frame: Change in score from Baseline to 9 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Elizabeth Madva, M.D. 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 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 2 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: finished, as of the sponsor's last update on 22 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of PP Sessions Completed by Participants (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2025.