UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness and feasibility study of the cognitive behavioral therapy program for irritable bowel syndrome
Title of the study (Brief title)	An open label pilot study of the cognitive behavioral therapy for irritable bowel syndrome
Region	Japan

Condition
Condition	Irritable bowel syndrome
Classification by specialty	Medicine in general Gastroenterology Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine feasibility and effectiveness of cognitive behavioral therapy for irritable bowel syndrome in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. The Japanese version of the irritable bowel syndrome-severity index (IBSSI-J) 2. Visceral sensitivity index (VSI)
Key secondary outcomes	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)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Cognitive Behavioral Therapy for Irritable Bowel Syndrome (Once a week, 10 sessions)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Persons diagnosed with irritable bowel syndrome based on the Rome III diagnostic criteria2. Those whose severity is moderate or severe (IBSSI-J score => 175) 3. Persons who can understand the purpose and content of this trial and give voluntary written informed consent.
Key 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).
Target sample size	20

Research contact person
Name of lead principal investigator	Tetsuya Ando
Organization	National Center of Neurology and Psychiatry
Division name	Department of Psychosomatic Research, National Institute of Mental Health
Address	4-1-1 Ogawahigashi Kodaira, Tokyo 187-8553, Japan
TEL	042-341-2711
Email	ando-t@ncnp.go.jp

Public contact
Name of contact person	Tetsuya Ando
Organization	National Center of Neurology and Psychiatry
Division name	Department of Psychosomatic Research, National Institute of Mental Health
Address	4-1-1 Ogawahigashi Kodaira, Tokyo 187-8553, Japan
TEL	042-341-2711
Homepage URL
Email	ando-t@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 19 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 03 Month 15 Day
Anticipated trial start date	2013 Year 03 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 12 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011972