JPRN-UMIN000010224
Completed
未知
Effectiveness and feasibility study of the cognitive behavioral therapy program for irritable bowel syndrome - An open label pilot study of the cognitive behavioral therapy for irritable bowel syndrome
ational Center of Neurology and Psychiatry0 sites20 target enrollmentMarch 19, 2013
ConditionsIrritable bowel syndrome
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Irritable bowel syndrome
- Sponsor
- ational Center of Neurology and Psychiatry
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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, 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).
Outcomes
Primary Outcomes
Not specified
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