Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-01 @ 4:10 AM
Study NCT ID:
NCT06866106
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Well-being in IBS: Strengths and Happiness (WISH) 2.0
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
The WISH Intervention for IBS: Feasibility, Preliminary Effects, and Candidate Gut-Brain Mechanisms
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: