A Taiwan-Adapted Self-Management Program for Adults With Irritable Bowel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comprehensive Self-Management Program, Usual Care.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Randomized Controlled Trial of a Taiwanese Version of a Comprehensive Self-Management Program for Adults With Irritable Bowel Syndrome
Overview
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.
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.
Interventions
- 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 the usual care group will continue to receive usual clinical care and complete scheduled study assessments.
Primary outcome measures
- Proportion of Participants Who Complete the 3-Month Follow-Up Assessment [Time frame: From enrollment to 3 months post-intervention]
- Proportion of Intervention Sessions Completed [Time frame: From Week 1 to Week 8]
- Mean Acceptability Score Immediately Post-Intervention [Time frame: Immediately post-intervention]
- Proportion of Participants With Complete Questionnaire Data [Time frame: Baseline, immediately post-intervention, and 3 months post-intervention]
Secondary outcome measures (12)
- Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 3 months post-intervention]
- Change From Baseline in Gut Microbiome Shannon Diversity Index Immediately Post-Intervention [Time frame: Baseline and immediately post-intervention]
- Change From Baseline in Gut Microbiome Richness Immediately Post-Intervention [Time frame: Baseline and immediately post-intervention]
Eligibility criteria
Inclusion Criteria:Adults aged 20 to 70 years
- 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
Exclusion criteria
- 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 -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07693907 · A202305137-CSMT-RCT