irritable bowel syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.People diagnosed by gastroenterologist and have have moderate or severe symptoms remaining after receiving symptom-targeted pharmacotherapy for 3 months or more. 2.People diagnosed with irritable bowel syndrome based on the Rome III or Rome IV diagnostic criteria 3.People who basically do not change (as much as possible) usual treatment for IBS during the research 4.People who are capable of continuous hospital visits and motivated 5.People who can communicate, read and write in Japanese 6.Persons who can understand the purpose and content of this trial and give voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1.People who has received psychotherapies 2.People who are currently undergoing treatment in psychiatry or psychosomatic department and judged that psychiatry or psychosomatic medicine doctor is inappropriate for participation in this study 3.People who are suffering from sever anxiety disorders and depression or with suicidal attempt (using PHQ-9) 4.Pregnant women 5.People who is treated or under treatment due to organic disease of the abdomen 6.People whom the principal investigator has determined to be unsuitable as a participant of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.the IBS Symptom Severity Score (IBS-SSS) 2.the IBS-Quality of Life Measure (IBS-QOL) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Irritable Bowel Syndrome-Global Improvement Scale(Japanese:IBS-GIS) 2.EuroQol-5D-5L(Japanese:EQ-5D-5L) 3.Patient Health Questionnaire-9(Japanese:PHQ-9) 4.Generalized Anxiety Disorder-7(Japanese:GAD-7) 5.Gastrointestinal Symptom Rating Scale(Japanese:GSRS) 6.The Composite Primary Symptom Reduction(CPSR) 7.Dropout rate 8.Adverse Events | — |
Countries
Japan
Contacts
Graduate school of Medicine and Faculty of Medicine Kyoto University Health Promotion and Human Behavior