A Taiwan-Adapted Self-Management Program for Adults With Irritable Bowel Syndrome (CSM-T-IBS)
2026년 7월 12일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
54
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Pei-Lin Yang, PhD
- 전화번호: 18778 +886-2-8792-3100
- 이메일: peilinyang@mail.ndmutsgh.edu.tw
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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 -
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants Who Complete the 3-Month Follow-Up Assessment
기간: 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
기간: 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
기간: 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
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention
기간: Baseline, immediately post-intervention, and 3 months post-intervention
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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
기간: 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
기간: Baseline, immediately post-intervention, and 3 months post-intervention
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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
기간: 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
기간: 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.
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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 Anxiety T-Score Immediately Post-Intervention and at 3 Months Post-Intervention
기간: Baseline, immediately post-intervention, and 3 months post-intervention
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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.
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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 Depression T-Score Immediately Post-Intervention and at 3 Months Post-Intervention
기간: 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
기간: 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
기간: Baseline, immediately post-intervention, and 3 months post-intervention
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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.
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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
기간: 3 months post-intervention
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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
기간: 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
기간: Baseline and immediately post-intervention
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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.
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Baseline and immediately post-intervention
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Change From Baseline in Fecal Calprotectin Concentration Immediately Post-Intervention
기간: Baseline and immediately post-intervention
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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.
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Baseline and immediately post-intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Pei-Lin Yang, PhD, School of Nursing National Defense Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 15일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2028년 7월 25일
연구 등록 날짜
최초 제출
2026년 7월 5일
QC 기준을 충족하는 최초 제출
2026년 7월 5일
처음 게시됨 (실제)
2026년 7월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 12일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- A202305137-CSMT-RCT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .