A Taiwan-Adapted Self-Management Program for Adults With Irritable Bowel Syndrome (CSM-T-IBS)
12 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
54
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Pei-Lin Yang, PhD
- Номер телефона: 18778 +886-2-8792-3100
- Электронная почта: peilinyang@mail.ndmutsgh.edu.tw
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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 -
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
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.
|
|
Другой: Usual Care
Participants assigned to this arm will continue to receive usual clinical care and complete scheduled study assessments.
|
Participants assigned to the usual care group will continue to receive usual clinical care and complete scheduled study assessments.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of Participants Who Complete the 3-Month Follow-Up Assessment
Временное ограничение: From enrollment to 3 months post-intervention
|
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
Временное ограничение: 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.
|
From Week 1 to Week 8
|
|
Mean Acceptability Score Immediately Post-Intervention
Временное ограничение: 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
Временное ограничение: 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.
|
Baseline, immediately post-intervention, and 3 months post-intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
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
Временное ограничение: 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
|
|
Change From Baseline in Patient-Reported Outcomes Measurement Information System Depression T-Score Immediately Post-Intervention and at 3 Months Post-Intervention
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
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
Временное ограничение: 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
|
|
Proportion of Participants Reporting Use of at Least One Self-Management Strategy at 3 Months Post-Intervention
Временное ограничение: 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 Gut Microbiome Shannon Diversity Index Immediately Post-Intervention
Временное ограничение: 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.
|
Baseline and immediately post-intervention
|
|
Change From Baseline in Gut Microbiome Richness Immediately Post-Intervention
Временное ограничение: 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
|
|
Change From Baseline in Fecal Calprotectin Concentration Immediately Post-Intervention
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Pei-Lin Yang, PhD, School of Nursing National Defense Medical Center
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
15 июля 2026 г.
Первичное завершение (Оцененный)
31 декабря 2027 г.
Завершение исследования (Оцененный)
25 июля 2028 г.
Даты регистрации исследования
Первый отправленный
5 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
5 июля 2026 г.
Первый опубликованный (Действительный)
9 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
15 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- A202305137-CSMT-RCT
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .