Irritable Bowel Syndrome
Conditions
Keywords
irritable bowel syndrome
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.
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
BEHAVIORALComprehensive 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.
OTHERUsual Care
Participants assigned to the usual care group will continue to receive usual clinical care and complete scheduled study assessments.
Sponsors
National Defense Medical Center, Taiwan
Tri-Service General Hospital (TSGH)
National Health Research Institutes, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Research staff who collect follow-up data will be blinded to participant assignment
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Complete the 3-Month Follow-Up Assessment | From enrollment to 3 months post-intervention | The proportion of enrolled participants who complete the 3-month post-intervention assessment will be calculated. |
| Proportion of Intervention Sessions Completed | From Week 1 to Week 8 | 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 | 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 | Baseline, immediately post-intervention, and 3 months post-intervention | The proportion of participants with complete questionnaire data at each assessment time point will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Baseline, immediately post-intervention, and 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 | Baseline, immediately post-intervention, and 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 | Baseline, immediately post-intervention, and 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. |
| 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 | 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. |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System Anxiety T-Score Immediately Post-Intervention and at 3 Months Post-Intervention | Baseline, immediately post-intervention, and 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. |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System Depression T-Score Immediately Post-Intervention and at 3 Months Post-Intervention | Baseline, immediately post-intervention, and 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. |
| Change From Baseline in Visceral Sensitivity Index Score Immediately Post-Intervention and at 3 Months Post-Intervention | Baseline, immediately post-intervention, and 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. |
| Change From Baseline in Work Productivity and Activity Impairment Percentage Immediately Post-Intervention and at 3 Months Post-Intervention | Baseline, immediately post-intervention, and 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. |
| Proportion of Participants Reporting Use of at Least One Self-Management Strategy at 3 Months Post-Intervention | 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. |
| Change From Baseline in Gut Microbiome Shannon Diversity Index Immediately Post-Intervention | Baseline and 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. |
| Change From Baseline in Gut Microbiome Richness Immediately Post-Intervention | Baseline and 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. |
| Change From Baseline in Fecal Calprotectin Concentration Immediately Post-Intervention | Baseline and 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. |
Contacts
CONTACTPei-Lin Yang, PhD
PRINCIPAL_INVESTIGATORPei-Lin Yang, PhD
School of Nursing National Defense Medical Center
Outcome results
None listed