A Taiwan-Adapted Self-Management Program for Adults With Irritable Bowel Syndrome (CSM-T-IBS)
12 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
54
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Pei-Lin Yang, PhD
- Número de teléfono: 18778 +886-2-8792-3100
- Correo electrónico: peilinyang@mail.ndmutsgh.edu.tw
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 -
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
|
|
Otro: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of Participants Who Complete the 3-Month Follow-Up Assessment
Periodo de tiempo: From enrollment to 3 months post-intervention
|
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
Periodo de tiempo: 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
Periodo de tiempo: Immediately post-intervention
|
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
Periodo de tiempo: 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.
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Baseline, immediately post-intervention, and 3 months post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline and immediately post-intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Pei-Lin Yang, PhD, School of Nursing National Defense Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
25 de julio de 2028
Fechas de registro del estudio
Enviado por primera vez
5 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de julio de 2026
Publicado por primera vez (Actual)
9 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A202305137-CSMT-RCT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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