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

Mass General Brigham

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Positive Psychology Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05289089

2021P002996

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Positive Psychology Intervention Group

Experimental group

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.

Treatment:

Behavioral: Positive Psychology Intervention

Wait list Control Group

Active Comparator group

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.

Treatment:

Behavioral: Positive Psychology Intervention