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.
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
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
Parallel
Comprehensive Self-Management Program
BehavioralParticipants 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.
Usual Care
Other interventionParticipants assigned to the usual care group will continue to receive usual clinical care and complete scheduled study assessments.
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.
Proportion of Intervention Sessions Completed
The proportion of assigned intervention sessions completed by participants in the comprehensive self-management program group will be calculated.
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.
Proportion of Participants With Complete Questionnaire Data
The proportion of participants with complete questionnaire data at each assessment time point will be calculated.
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.
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.
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.
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.
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National Defense Medical Center, Taiwan
Lead sponsor
Tri-Service General Hospital (TSGH)
Collaborator
National Health Research Institutes, Taiwan
Collaborator
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