A Taiwan-Adapted Self-Management Program for Adults With Irritable Bowel Syndrome (CSM-T-IBS)
12 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
54
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Pei-Lin Yang, PhD
- Numero di telefono: 18778 +886-2-8792-3100
- Email: peilinyang@mail.ndmutsgh.edu.tw
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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 -
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of Participants Who Complete the 3-Month Follow-Up Assessment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Pei-Lin Yang, PhD, School of Nursing National Defense Medical Center
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 luglio 2026
Completamento primario (Stimato)
31 dicembre 2027
Completamento dello studio (Stimato)
25 luglio 2028
Date di iscrizione allo studio
Primo inviato
5 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
5 luglio 2026
Primo Inserito (Effettivo)
9 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- A202305137-CSMT-RCT
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .