Irritable bowel syndrome
Conditions
Interventions
Cognitive Behavioral Therapy for irritable bowel syndrome (Once a week, 10 sessions) and treatment as usual(TAU) including drug therapy and lifestyle advice.
Treatment as usual (TAU) for Irritable bow
Sponsors
Tohoku University
Tohoku University, University of Tokyo, National Center for Global Health and Medicine, Kohnodai Hospital National Center for Global Health and Medicine, International University of Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Persons diagnosed with irritable bowel syndrome based on the Rome 4 diagnostic criteria 2.Those whose severity is moderate or severe(IBSSI-J score =>175 and over) 3.Persons who can understand the purpose and contents of this trial and give voluntary written an informed consent.
Exclusion criteria
Exclusion criteria: 1.Person in whom organic disease is suggested by the presence of warning symptoms*. 2.Persons with a history of or concomitant inflammatory bowel disease, malignant tumor, or other bowel disease which could cause the current bowel symptoms. 3.Persons suffering from major psychiatric disease, such as psychotic disorders, bipolar disorder, substance abuse-related disorders, eating disorders, obsessive and compulsive disorders,or PTSD (persons with anxiety disorders, somatic symptom and related disorders and depression without suicidal ideation are not excluded) 4.Persons with antisocial personality disorders. 5.Persons observed to have significant suicidal ideation at screening. 6.Persons with another past or present psychiatric or physical disease that is likely to interfere with continuation and evaluation of the study. 7. Persons experiencing any other type of marked chronic pain. 8.Those taking narcotic analgesics. 9.Persons who anticipate difficulty attending 10 sessions as an outpatient during the 16-week CBT implementation period. 10.Those who have previously received structured individual CBT. 11.Those for whom verbal and written communication in Japanese is not possible 12.Pregnant or lactating women. 13. Any other person whom the principal investigator has determined to be unsuitable as a participant of the study. *Warning symptoms list. 1.Symptoms which first appeared after 50 years of age. 2.Any rectal bleeding that has not undergone sufficient medical investigation (excluding that caused by known hemorrhoids). 3.Diarrhea-predominant IBS in which no colonoscopy investigation has been conducted. 4.Unexplained weight loss without a change in eating habits. 5.Nocturnal symptoms sufficient to cause insomnia. 6.The presence of warning symptoms (anemia, inflammatory reactions, or fecal occult blood). 7.Persons with a family history of colon cancer in a first- or second-degree relative (grandparents, parents, siblings, or children).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Japanese version of the irritable bowel syndrome-severity index (IBSSI-J) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Visceral sensitivity index(VSI) 2.IBS-Global Improvement Scale(IBS-GIS) 3.The Japanese version of the irritable bowel syndrome quality of life instrument(IBS-QOL-J) 4.Medical Outcome Study 36-item Short Form Health Survey (SF-36) 5.Beck Depression Inventory-Second Edition (BDI-2) 6.State Trait Anxiety Inventory(STAI) 7.IBS Diary 8.Body Vigilance Scale(BVS) 9.Cognitive control scale 10.Patient characteristics information | — |
Countries
Japan
Contacts
Public ContactTetsuya Ando
National Center of Neurology and Psychiatry Department of Behavioral Medicine
Outcome results
None listed