A Taiwan-Adapted Self-Management Program for Adults With Irritable Bowel Syndrome

NCT07693907 | Not Yet Recruiting

• 1 other identifier: A202305137-CSMT-RCT
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot randomized controlled trial will evaluate the feasibility, acceptability, and preliminary effects of a Taiwanese version of a comprehensive self-management program for adults with irritable bowel syndrome. Participants will be randomized to the self-management program or usual care. Outcomes will be assessed at baseline, immediately after the intervention, and three months after the intervention.

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome

Outcome Measures

Primary Outcomes (4)

• Proportion of Participants Who Complete the 3-Month Follow-Up Assessment

  The proportion of enrolled participants who complete the 3-month post-intervention assessment will be calculated.

  From enrollment to 3 months post-intervention

• Proportion of Intervention Sessions Completed

  The proportion of assigned intervention sessions completed by participants in the comprehensive self-management program group will be calculated.

  From Week 1 to Week 8

• Mean Acceptability Score Immediately Post-Intervention

  Acceptability of the study procedures and intervention will be assessed using investigator-developed acceptability items. Higher scores indicate greater acceptability.

  Immediately post-intervention

• Proportion of Participants With Complete Questionnaire Data

  The proportion of participants with complete questionnaire data at each assessment time point will be calculated.

  Baseline, immediately post-intervention, and 3 months post-intervention

Secondary Outcomes (13)

• Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention

  Baseline, immediately post-intervention, and 3 months post-intervention

• Change From Baseline in Irritable Bowel Syndrome Symptom Severity Scale Score Immediately Post-Intervention and at 3 Months Post-Intervention

  Baseline, immediately post-intervention, and 3 months post-intervention

• Change From Baseline in Percentage of Days With Moderate to Very Severe Gastrointestinal Symptoms Immediately Post-Intervention and at 3 Months Post-Intervention

  Baseline, immediately post-intervention, and 3 months post-intervention

• Change From Baseline in Patient-Reported Outcomes Measurement Information System Fatigue T-Score Immediately Post-Intervention and at 3 Months Post-Intervention

  Baseline, immediately post-intervention, and 3 months post-intervention

• Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance T-Score Immediately Post-Intervention and at 3 Months Post-Intervention

  Baseline, immediately post-intervention, and 3 months post-intervention

Study Arms (2)

Comprehensive Self-Management Program

EXPERIMENTAL

Participants assigned to this arm will receive an 8-session Taiwan-adapted comprehensive self-management program for irritable bowel syndrome over approximately 8 weeks, in addition to scheduled study assessments. The program includes irritable bowel syndrome education, symptom monitoring, relaxation practice, cognitive strategies, dietary self-management, sleep-related content, problem solving, and daily-life symptom management.

Behavioral: Comprehensive Self-Management Program

Usual Care

OTHER

Participants assigned to this arm will continue to receive usual clinical care and complete scheduled study assessments.

Other: Usual Care

Interventions

Comprehensive Self-Management Program BEHAVIORAL

Participants assigned to the intervention group will receive an 8-session comprehensive self-management program over approximately 8 weeks. The program includes irritable bowel syndrome education, symptom monitoring, relaxation practice, cognitive strategies, dietary self-management, sleep-related content, problem solving, and daily-life symptom management.

Comprehensive Self-Management Program

Usual Care OTHER

Participants assigned to the usual care group will continue to receive usual clinical care and complete scheduled study assessments.

Usual Care

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets Rome criteria for irritable bowel syndrome
• Has a healthcare provider diagnosis of irritable bowel syndrome
• Able to read and speak Mandarin
• Willing to provide informed consent and participate in study procedures

You may not qualify if:

• Pregnant or breastfeeding
• Poorly controlled mental health problems, including history of psychosis, bipolar disorder, drug or alcohol abuse or dependence, or suicide attempt within the past 2 years unless explained by significant loss
• Surgery or hospitalization within the past month
• Unable to complete study questionnaires or study procedures
• Unable to complete study questionnaires or study procedures -

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead
• National Health Research Institutes, Taiwan: collaborator
• Tri-Service General Hospital (TSGH): collaborator

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Pei-Lin Yang, PhD

  School of Nursing National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Lin Yang, PhD

CONTACT

+886-2-8792-3100; peilinyang@mail.ndmutsgh.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff who collect follow-up data will be blinded to participant assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 9, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 25, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share