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

NCT05289089 | Completed

• 1 other identifier: 2021P002996
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of PP Sessions Completed by Participants

  Measured by proportion of PP sessions completed by participants in each group.

  9 weeks

Secondary Outcomes (21)

• Ease of PP Exercises

  Weeks 1-9

• Utility of PP exercises

  Weeks 1-9

• Change in Positive Affect

  Change in score from Baseline to 9 weeks

• Change in Optimism

  Change in score from Baseline to 9 weeks

• Change in Depression

  Change in score from Baseline to 9 weeks

Study Arms (2)

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.

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.

Behavioral: Positive Psychology Intervention

Interventions

Positive Psychology Intervention BEHAVIORAL

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.

Positive Psychology Intervention Group; Wait list Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Elizabeth Madva, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized trial comparing PP intervention versus wait list control

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: March 25, 2022
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)