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| Name | Class |
|---|---|
| Tri-Service General Hospital (TSGH) | OTHER |
| National Health Research Institutes, Taiwan | OTHER |
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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.
The study will enroll adults with irritable bowel syndrome and randomize them 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Usual Care | Other | Participants assigned to this arm will continue to receive usual clinical care and complete scheduled study assessments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Irritable Bowel Syndrome Quality of Life Immediately Post-Intervention and at 3 Months Post-Intervention | rritable bowel syndrome-related quality of life will be assessed using the IBS-Quality of Life questionnaire. Higher scores indicate better quality of life. | Baseline, immediately post-intervention, and 3 months post-intervention |
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Inclusion Criteria:Adults aged 20 to 70 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pei-Lin Yang, PhD | Contact | +886-2-8792-3100 | 18778 | peilinyang@mail.ndmutsgh.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Pei-Lin Yang, PhD | School of Nursing National Defense Medical Center | Principal Investigator |
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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.
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Parallel Assignment
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Research staff who collect follow-up data will be blinded to participant assignment
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| Usual Care | Other | Participants assigned to the usual care group will continue to receive usual clinical care and complete scheduled study assessments. |
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| Change From Baseline in Irritable Bowel Syndrome Symptom Severity Immediately Post-Intervention and at 3 Months Post-Intervention | Irritable bowel syndrome symptom severity will be assessed using the IBS-Symptom Severity Scale. Higher scores indicate greater symptom severity. | Baseline, immediately post-intervention, and 3 months post-intervention |
| Change From Baseline in Daily Gastrointestinal Symptom Score 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 based on the percentage of days with at least one moderate to very severe gastrointestinal symptom. | Baseline, immediately post-intervention, and 3 months post-intervention |
| Change From Baseline in Fatigue Immediately Post-Intervention and at 3 Months Post-Intervention | Fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System Fatigue scale. Higher scores indicate greater fatigue. | Baseline, immediately post-intervention, and 3 months post-intervention |
| Change From Baseline in Sleep Disturbance 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. Higher scores indicate greater sleep disturbance. | Baseline, immediately post-intervention, and 3 months post-intervention |
| Change From Baseline in Anxiety Symptoms Immediately Post-Intervention and at 3 Months Post-Intervention | Anxiety symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System Anxiety scale. Higher scores indicate greater anxiety symptoms. | Baseline, immediately post-intervention, and 3 months post-intervention |
| Change From Baseline in Depressive Symptoms Immediately Post-Intervention and at 3 Months Post-Intervention | Depressive symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System Depression scale. Higher scores indicate greater depressive symptoms. | Baseline, immediately post-intervention, and 3 months post-intervention |
| Change From Baseline in Gastrointestinal Symptom-Specific Anxiety Immediately Post-Intervention and at 3 Months Post-Intervention | Gastrointestinal symptom-specific anxiety will be assessed using the Visceral Sensitivity Index. Higher scores indicate greater gastrointestinal symptom-specific anxiety. | Baseline, immediately post-intervention, and 3 months post-intervention |
| Change From Baseline in Work Productivity and Activity Impairment 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. | Baseline, immediately post-intervention, and 3 months post-intervention |
| Proportion of Participants Using Self-Management Strategies 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 Exploratory Stool-Based Biological Measures Immediately Post-Intervention | Exploratory stool-based biological measures will be assessed from stool samples, including gut microbiome summary measures and fecal calprotectin. | Baseline and immediately post-intervention |
| D004066 | Digestive System Diseases |