irritable bowel syndrome
Conditions
Interventions
cognitive behavioral therapy seven sessions, each lasting 50 minutes Cognitive behavioral therapy consisted of the following components: 1. Psychoeducation 2. Self-monitoring 3. Cognitive restruc
Sponsors
Saitama Prefectural University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gender: Not specified 2. Age: 18 years or older and under 65 years 3. Individuals with symptoms of irritable bowel syndrome (IBS) based on the Rome IV diagnostic criteria 4. Japanese individuals 5. Individuals who are able to understand the purpose and procedures of the study and are willing to participate voluntarily 6. Individuals who are able to provide written informed consent 7. Individuals who are able to participate in all required assessments during the study period (pre-intervention, mid-intervention, post-intervention, and follow-ups at 1, 3, and 6 months)
Exclusion criteria
Exclusion criteria: 1. People diagnosed with gastrointestinal diseases other than IBS 2. People using electronic medical devices, such as cardiac pacemakers 3. People deemed inappropriate for study participation by the investigators 4. People who are pregnant or breastfeeding 5. People currently participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. CS-FBD-J (Cognitive Scale for Functional Bowel Disorders) Measurement method: Self-reported CS-FBD-J questionnaire Measurement timing: Baseline (pre-intervention), mid-intervention, post-intervention, and at 1, 3, and 6 months after the completion of the intervention Assessment content: Cognitive responses to functional gastrointestinal disorders Primary evaluation point: Change in CS-FBD-J score from baseline (pre-intervention) to post-intervention 2. IBS-BRQ-J (Behavioral Responses Questionnaire) Measurement method: Self-reported IBS-BRQ-J questionnaire Measurement timing: Baseline (pre-intervention), mid-intervention, post-intervention, and at 1, 3, and 6 months after the completion of the intervention Assessment content: Behavioral responses related to IBS symptoms Primary evaluation point: Change in IBS-BRQ-J score from baseline (pre-intervention) to post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in brain wave patterns Measurement method: Electroencephalogram (EEG) measurements Measurement timing: Baseline (pre-intervention), mid-intervention, and post-intervention Assessment content: Resting-state brain activity and brain activity related to interoceptive processing 2. Change in Irritable Bowel Syndrome Severity Index (IBS-SI) score Measurement method: Self-reported IBS Severity Index (IBS-SI) questionnaire Measurement timing: Baseline (pre-intervention), mid-intervention, post-intervention, and at 1, 3, and 6 months after the completion of the intervention Assessment content: Overall IBS symptom severity, including abdominal pain intensity and frequency, abdominal bloating, satisfaction with bowel habits, and interference with daily life Primary evaluation point: Change in IBS-SI score from baseline (pre-intervention) to post-intervention 3. Improvement in IBS-specific quality of life (IBS-QOL) score Measurement method: IBS Quality of Life (IBS-QOL) questionnaire Measurement timing: Baseline (pre-intervention), mid-intervention, post-intervention, and at 1, 3, and 6 months after the completion of the intervention 4. Changes in psychological measures Measurement method: Visceral Sensitivity Index (VSI) and Hospital Anxiety and Depression Scale (HADS) Measurement timing: Baseline (pre-intervention), mid-intervention, post-intervention, and at 1, 3, and 6 months after the completion of the intervention | — |
Countries
Japan
Contacts
Public ContactMutsumi Kaneko
Saitama Prefectural University Secretariat, Research and Community Relations
Outcome results
None listed