UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and feasibility study of the Group Cognitive Behavioral Therapy program for Irritable Bowel Syndrome:open label pilot study
Title of the study (Brief title)	An open label pilot study of the Group 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 the efficacy and feasibility of group cognitive behavioral therapy for irritable bowel syndrome
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1.The Japanese version of the irritable bowel syndrome quality of life instrument(IBS-QOL-J) 2.The Japanese version of the irritable bowel syndrome-severity index(IBSSI-J)
Key secondary outcomes	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.Dropout rate 7.Adverse Events

Base
Study type	Interventional

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

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,90 minutes session,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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Persons diagnosed with irritable bowel syndrome based on the Rome III or Rome IV diagnostic criteria 2.Persons who can understand the purpose and content of this trial and give voluntary written informed consent 3.patients who continue to have moderate or severe symptoms after 3 months of medical management 4.Persons who never took psychological treatment for IBS in the past
Key exclusion criteria	1.Person in whom organic disease is suggested by the presence of warning symptoms** 2.Those who can not understand Japanese 3.Persons suffering from sever anxiety disorders and depression or with suicidal ideation (diagnose by PHQ-9) 4.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.A medical history that makes evaluation of this study difficult. (Past and present) 8.Persons with a family history of colon cancer in a first or second degree relative (grandparents, parents, siblings or children)
Target sample size	15

Research contact person
Name of lead principal investigator	Toshiaki Furukawa
Organization	Graduate school of Medicine and Faculty of Medicine Kyoto University
Division name	Health Promotion and Human Behavior
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Email	furukawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Shino Kikuchi
Organization	Graduate school of Medicine and Faculty of Medicine Kyoto University
Division name	Health Promotion and Human Behavior
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Homepage URL
Email	shino_k@kuhp.kyoto-u.co.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Ministry of Education Culture SportsScience and Technology Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Center for Cognitive Behavior Therapy and Research
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	高槻赤十字病院（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 17 Day
Anticipated trial start date	2017 Year 11 Month 25 Day
Last follow-up date	2018 Year 06 Month 30 Day
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	2017 Year 08 Month 17 Day
Last modified on	2018 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032075