A Pilot Randomized Controlled Trial of a Taiwanese Version of a Comprehensive Self-Management Program for Adults With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 主要终点
- Proportion of Participants Who Complete the 3-Month Follow-Up Assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research staff who collect follow-up data will be blinded to participant assignment
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 -
研究组 & 干预措施
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.
干预措施: Comprehensive Self-Management Program (Behavioral)
Usual Care
Participants assigned to this arm will continue to receive usual clinical care and complete scheduled study assessments.
干预措施: Usual Care (Other)
结局指标
主要结局
Proportion of Participants Who Complete the 3-Month Follow-Up Assessment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change From Baseline in Irritable Bowel Syndrome Quality of Life Immediately Post-Intervention and at 3 Months Post-Intervention(Baseline, immediately post-intervention, and 3 months post-intervention)
- Change From Baseline in Irritable Bowel Syndrome Symptom Severity Immediately Post-Intervention and at 3 Months Post-Intervention(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(Baseline, immediately post-intervention, and 3 months post-intervention)
- Change From Baseline in Fatigue Immediately Post-Intervention and at 3 Months Post-Intervention(Baseline, immediately post-intervention, and 3 months post-intervention)
- Change From Baseline in Sleep Disturbance Immediately Post-Intervention and at 3 Months Post-Intervention(Baseline, immediately post-intervention, and 3 months post-intervention)
- Change From Baseline in Anxiety Symptoms Immediately Post-Intervention and at 3 Months Post-Intervention(Baseline, immediately post-intervention, and 3 months post-intervention)
- Change From Baseline in Depressive Symptoms Immediately Post-Intervention and at 3 Months Post-Intervention(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(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(Baseline, immediately post-intervention, and 3 months post-intervention)
- Proportion of Participants Using Self-Management Strategies at 3 Months Post-Intervention(3 months post-intervention)
- Change From Baseline in Exploratory Stool-Based Biological Measures Immediately Post-Intervention(Baseline and immediately post-intervention)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Proportion of Participants Reporting Use of at Least One Self-Management Strategy at 3 Months Post-Intervention(3 months post-intervention)
- Change From Baseline in Gut Microbiome Shannon Diversity Index Immediately Post-Intervention(Baseline and immediately post-intervention)
- Change From Baseline in Gut Microbiome Richness Immediately Post-Intervention(Baseline and immediately post-intervention)
- Change From Baseline in Fecal Calprotectin Concentration Immediately Post-Intervention(Baseline and immediately post-intervention)
研究者
Pei-Lin Yang
Associate Professor
National Defense Medical Center, Taiwan