A Taiwan-Adapted Self-Management Program for Adults With Irritable Bowel Syndrome (CSM-T-IBS)
2026年7月12日 更新者：Pei-Lin Yang、National Defense Medical Center, Taiwan
A Pilot Randomized Controlled Trial of a Taiwanese Version of a Comprehensive Self-Management Program for Adults With Irritable Bowel Syndrome
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
54
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Pei-Lin Yang, PhD
- 电话号码：18778 +886-2-8792-3100
- 邮箱：peilinyang@mail.ndmutsgh.edu.tw
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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 -
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
|
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其他：Usual Care
Participants assigned to this arm will continue to receive usual clinical care and complete scheduled study assessments.
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Participants assigned to the usual care group will continue to receive usual clinical care and complete scheduled study assessments.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of Participants Who Complete the 3-Month Follow-Up Assessment
大体时间：From enrollment to 3 months post-intervention
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The proportion of enrolled participants who complete the 3-month post-intervention assessment will be calculated.
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From enrollment to 3 months post-intervention
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Proportion of Intervention Sessions Completed
大体时间：From Week 1 to Week 8
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The proportion of assigned intervention sessions completed by participants in the comprehensive self-management program group will be calculated.
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From Week 1 to Week 8
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Mean Acceptability Score Immediately Post-Intervention
大体时间：Immediately post-intervention
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Acceptability of the study procedures and intervention will be assessed using investigator-developed acceptability items.
Higher scores indicate greater acceptability.
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Immediately post-intervention
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Proportion of Participants With Complete Questionnaire Data
大体时间：Baseline, immediately post-intervention, and 3 months post-intervention
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The proportion of participants with complete questionnaire data at each assessment time point will be calculated.
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Baseline, immediately post-intervention, and 3 months post-intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention
大体时间：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.
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Baseline, immediately post-intervention, and 3 months post-intervention
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Change From Baseline in Irritable Bowel Syndrome Symptom Severity Scale Score Immediately Post-Intervention and at 3 Months Post-Intervention
大体时间：Baseline, immediately post-intervention, and 3 months post-intervention
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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.
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Baseline, immediately post-intervention, and 3 months post-intervention
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Change From Baseline in Percentage of Days With Moderate to Very Severe Gastrointestinal Symptoms Immediately Post-Intervention and at 3 Months Post-Intervention
大体时间：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.
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Baseline, immediately post-intervention, and 3 months post-intervention
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Change From Baseline in Patient-Reported Outcomes Measurement Information System Fatigue T-Score Immediately Post-Intervention and at 3 Months Post-Intervention
大体时间：Baseline, immediately post-intervention, and 3 months post-intervention
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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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Baseline, immediately post-intervention, and 3 months post-intervention
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Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance T-Score Immediately Post-Intervention and at 3 Months Post-Intervention
大体时间：Baseline, immediately post-intervention, and 3 months post-intervention
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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.
|
Baseline, immediately post-intervention, and 3 months post-intervention
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Change From Baseline in Patient-Reported Outcomes Measurement Information System Anxiety T-Score Immediately Post-Intervention and at 3 Months Post-Intervention
大体时间：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.
|
Baseline, immediately post-intervention, and 3 months post-intervention
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Change From Baseline in Patient-Reported Outcomes Measurement Information System Depression T-Score Immediately Post-Intervention and at 3 Months Post-Intervention
大体时间：Baseline, immediately post-intervention, and 3 months post-intervention
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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.
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Baseline, immediately post-intervention, and 3 months post-intervention
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Change From Baseline in Visceral Sensitivity Index Score Immediately Post-Intervention and at 3 Months Post-Intervention
大体时间：Baseline, immediately post-intervention, and 3 months post-intervention
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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.
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Baseline, immediately post-intervention, and 3 months post-intervention
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Change From Baseline in Work Productivity and Activity Impairment Percentage Immediately Post-Intervention and at 3 Months Post-Intervention
大体时间：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.
|
Baseline, immediately post-intervention, and 3 months post-intervention
|
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Proportion of Participants Reporting Use of at Least One Self-Management Strategy at 3 Months Post-Intervention
大体时间：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.
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3 months post-intervention
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Change From Baseline in Gut Microbiome Shannon Diversity Index Immediately Post-Intervention
大体时间：Baseline and immediately post-intervention
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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.
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Baseline and immediately post-intervention
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Change From Baseline in Gut Microbiome Richness Immediately Post-Intervention
大体时间：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.
|
Baseline and immediately post-intervention
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Change From Baseline in Fecal Calprotectin Concentration Immediately Post-Intervention
大体时间：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.
|
Baseline and immediately post-intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Pei-Lin Yang, PhD、School of Nursing National Defense Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月15日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年7月25日
研究注册日期
首次提交
2026年7月5日
首先提交符合 QC 标准的
2026年7月5日
首次发布 (实际的)
2026年7月9日
研究记录更新
最后更新发布 (实际的)
2026年7月15日
上次提交的符合 QC 标准的更新
2026年7月12日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.