A Taiwan-Adapted Self-Management Program for Adults With Irritable Bowel Syndrome (CSM-T-IBS)

A Pilot Randomized Controlled Trial of a Taiwanese Version of a Comprehensive Self-Management Program for Adults With Irritable Bowel Syndrome

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Comprehensive Self-Management Program; Other: Usual Care

Detailed Description

The study will enroll adults with irritable bowel syndrome and randomize participants in a 2:1 ratio to an 8-session comprehensive self-management program or usual care. 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. The pilot trial will assess recruitment, retention, intervention adherence, acceptability, satisfaction, and preliminary changes in symptom-related outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei-Lin Yang, PhD; Phone Number: 18778 +886-2-8792-3100; Email: peilinyang@mail.ndmutsgh.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:Adults aged 20 to 70 years

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

Exclusion Criteria:

1. Pregnant or breastfeeding
2. 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
3. Surgery or hospitalization within the past month
4. Unable to complete study questionnaires or study procedures
5. Unable to complete study questionnaires or study procedures -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive Self-Management Program; 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; 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.
Other: Usual Care; Participants assigned to this arm will continue to receive usual clinical care and complete scheduled study assessments.	Other: Usual Care; Participants assigned to the usual care group will continue to receive usual clinical care and complete scheduled study assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention	Irritable bowel syndrome-related quality of life will be assessed using the Irritable Bowel Syndrome Quality of Life questionnaire. Total scores range from 0 to 100, with higher scores indicating better quality of life.	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	Irritable bowel syndrome symptom severity will be assessed using the Irritable Bowel Syndrome Symptom Severity Scale. Total scores range from 0 to 500, with higher scores indicating greater symptom severity.	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	Daily gastrointestinal symptoms will be assessed using a daily symptom diary over 2 weeks. The score will be calculated as the percentage of days with at least one moderate to very severe gastrointestinal symptom, ranging from 0% to 100%. Higher percentages indicate more frequent moderate to very severe gastrointestinal symptoms.	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	Fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System Fatigue scale. Scores are reported as standardized T-scores, with a mean of 50 and a standard deviation of 10 in the reference population. Higher scores indicate greater fatigue.	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	Sleep disturbance will be assessed using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance scale. Scores are reported as standardized T-scores, with a mean of 50 and a standard deviation of 10 in the reference population. Higher scores indicate greater sleep disturbance.	Baseline, immediately post-intervention, and 3 months post-intervention
Change From Baseline in Patient-Reported Outcomes Measurement Information System Anxiety T-Score Immediately Post-Intervention and at 3 Months Post-Intervention	Anxiety symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System Anxiety scale. Scores are reported as standardized T-scores, with a mean of 50 and a standard deviation of 10 in the reference population. Higher scores indicate greater anxiety symptoms.	Baseline, immediately post-intervention, and 3 months post-intervention
Change From Baseline in Patient-Reported Outcomes Measurement Information System Depression T-Score Immediately Post-Intervention and at 3 Months Post-Intervention	Depressive symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System Depression scale. Scores are reported as standardized T-scores, with a mean of 50 and a standard deviation of 10 in the reference population. Higher scores indicate greater depressive symptoms.	Baseline, immediately post-intervention, and 3 months post-intervention
Change From Baseline in Visceral Sensitivity Index Score Immediately Post-Intervention and at 3 Months Post-Intervention	Gastrointestinal symptom-specific anxiety will be assessed using the Visceral Sensitivity Index. Total scores range from 0 to 75, with higher scores indicating greater gastrointestinal symptom-specific anxiety.	Baseline, immediately post-intervention, and 3 months post-intervention
Change From Baseline in Work Productivity and Activity Impairment Percentage Immediately Post-Intervention and at 3 Months Post-Intervention	Work productivity and activity impairment will be assessed using the Work Productivity and Activity Impairment Questionnaire-Irritable Bowel Syndrome. Scores are reported as percentages from 0% to 100%, with higher percentages indicating greater impairment.	Baseline, immediately post-intervention, and 3 months post-intervention
Proportion of Participants Reporting Use of at Least One Self-Management Strategy at 3 Months Post-Intervention	Use of self-management strategies will be assessed by asking participants how often they use each strategy. The proportion of participants reporting use of at least one self-management strategy will be calculated.	3 months post-intervention
Change From Baseline in Gut Microbiome Shannon Diversity Index Immediately Post-Intervention	Gut microbiome Shannon diversity index will be calculated from stool samples using 16S ribosomal RNA gene sequencing. Higher values indicate greater within-sample microbial diversity.	Baseline and immediately post-intervention
Change From Baseline in Gut Microbiome Richness Immediately Post-Intervention	Gut microbiome richness will be calculated from stool samples using 16S ribosomal RNA gene sequencing. Higher values indicate a greater number of observed microbial taxa.	Baseline and immediately post-intervention
Change From Baseline in Fecal Calprotectin Concentration Immediately Post-Intervention	Fecal calprotectin concentration will be measured from stool samples using enzyme-linked immunosorbent assay. Results will be reported in micrograms per gram of stool, with higher values indicating greater intestinal inflammation.	Baseline and immediately post-intervention

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan
• Collaborators: National Health Research Institutes, Taiwan; Tri-Service General Hospital (TSGH)
• Investigators: Principal Investigator: Pei-Lin Yang, PhD, School of Nursing National Defense Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 25, 2028

Study Registration Dates

• First Submitted: July 5, 2026
• First Submitted That Met QC Criteria: July 5, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: irritable bowel syndrome
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: A202305137-CSMT-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available to other researchers. The study involves a small pilot sample and collects symptom-related and psychosocial data from adults with irritable bowel syndrome. Public or external sharing of individual participant data may increase the risk of participant re-identification and is not planned under the current informed consent and ethics approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No