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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Psychology Intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive Psychology Intervention Group

Wait list Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of PP Sessions Completed by Participants
Measured by proportion of PP sessions completed by participants in each group.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 11, 2022
Last Updated
April 12, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT05289089
Brief Title
Well-being in IBS: Strengths and Happiness (WISH)
Official Title
The Well-being in IBS: Strengths and Happiness (WISH) Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
April 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Harvard Medical School (HMS and HSDM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial comparing PP intervention versus wait list control
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Psychology Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait list Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive Psychology Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of PP Sessions Completed by Participants
Description
Measured by proportion of PP sessions completed by participants in each group.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Ease of PP Exercises
Description
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.
Time Frame
Weeks 1-9
Title
Utility of PP exercises
Description
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.
Time Frame
Weeks 1-9
Title
Change in Positive Affect
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Optimism
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Depression
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Anxiety
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Gastrointestinal (GI) symptom specific anxiety
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Ability to Bounce Back from Stress
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Ability to Cope with Stress and Adversity
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Response to Pain
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Perceived Stress
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in IBS Health-related Quality of Life
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in IBS Symptom Severity
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Self-Reported Physical Activity
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Adherence to a Physician-Recommended Diet
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Adherence to Medications
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Avoidant and Restrictive Food Intake Disorder Symptoms
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in Eating Behaviors
Description
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.
Time Frame
Change in score from Baseline to 9 weeks
Title
Change in IBS diagnostic criteria
Description
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.
Time Frame
Change in score from Baseline to 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Madva, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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