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A Taiwan-Adapted Self-Management Program for Adults With Irritable Bowel Syndrome (CSM-T-IBS)

12 de julho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

54

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:Adults aged 20 to 70 years

  1. Meets Rome criteria for irritable bowel syndrome
  2. Has a healthcare provider diagnosis of irritable bowel syndrome
  3. Able to read and speak Mandarin
  4. Willing to provide informed consent and participate in study procedures

Exclusion Criteria:

  1. Pregnant or breastfeeding
  2. 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
  3. Surgery or hospitalization within the past month
  4. Unable to complete study questionnaires or study procedures
  5. Unable to complete study questionnaires or study procedures -

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: Comprehensive Self-Management Program
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.
Outro: Usual Care
Participants assigned to this arm will continue to receive usual clinical care and complete scheduled study assessments.
Outro: Usual Care
Participants assigned to the usual care group will continue to receive usual clinical care and complete scheduled study assessments.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of Participants Who Complete the 3-Month Follow-Up Assessment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Defense Medical Center, Taiwan

Colaboradores

National Health Research Institutes, Taiwan
Tri-Service General Hospital (TSGH)

Investigadores

  • Investigador principal: Pei-Lin Yang, PhD, School of Nursing National Defense Medical Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de julho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2027

Conclusão do estudo (Estimado)

25 de julho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

5 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de julho de 2026

Primeira postagem (Real)

9 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • A202305137-CSMT-RCT

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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