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Trials / Completed

CompletedNCT05289089

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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: 1. Examine the feasibility and acceptability of a 9-week, telephone-delivered PP intervention adapted to the IBS population 2. Explore the impact of the PP intervention on psychological, behavioral, and health-related outcomes, compared to a wait list control group.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPositive 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.

Timeline

Start date
2022-03-25
Primary completion
2023-04-11
Completion
2023-04-11
First posted
2022-03-21
Last updated
2025-06-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05289089. Inclusion in this directory is not an endorsement.