Effectiveness and feasibility study of the cognitive behavioral therapy program for irritable bowel syndrome
- Conditions
- Irritable bowel syndrome
- Registration Number
- JPRN-UMIN000010224
- Lead Sponsor
- ational Center of Neurology and Psychiatry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Not provided
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, or eating disorders (persons with anxiety 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The Japanese version of the irritable bowel syndrome-severity index (IBSSI-J) 2. Visceral sensitivity index (VSI)
- Secondary Outcome Measures
Name Time Method 1.IBS-Global Improvement Scale (IBS-GIS) 2.The Japanese version of the irritable bowel syndrome quality of life instrument (IBS-QOL-J) 3.Medical Outcome Study 36-item Short Form Health Survey (SF-36) 4.Beck Depression Inventory-Second Edition (BDI-2) 5.State Trait Anxiety Inventory (STAI) 6.Overall Anxiety Severity and Impairment Scale (OASIS) 7.Overall Depression Severity and Impairment Scale (ODSIS) 8.EuroQol (EQ5D)