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

12. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

54

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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 -

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Sonstiges: Usual Care
Participants assigned to this arm will continue to receive usual clinical care and complete scheduled study assessments.
Sonstiges: Usual Care
Participants assigned to the usual care group will continue to receive usual clinical care and complete scheduled study assessments.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of Participants Who Complete the 3-Month Follow-Up Assessment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Irritable Bowel Syndrome Quality of Life Score Immediately Post-Intervention and at 3 Months Post-Intervention
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Defense Medical Center, Taiwan

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

25. Juli 2028

Studienanmeldedaten

Zuerst eingereicht

5. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juli 2026

Zuerst gepostet (Tatsächlich)

9. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • A202305137-CSMT-RCT

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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