UMIN-CTR Clinical Trial

Basic information
Public title	Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome A Cost-Utility Analysis: Results from a Randomized Controlled Trial
Acronym	Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome A Cost-Utility Analysis
Scientific Title	Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome A Cost-Utility Analysis: Results from a Randomized Controlled Trial
Scientific Title:Acronym	Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome A Cost-Utility Analysis
Region	Japan

Condition
Condition	Irritable Bowel Syndrome
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigating the Cost-Effectiveness of Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome
Basic objectives2	Others
Basic objectives -Others	cost utility
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EQ-5D-5L
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Age between 18 and 75 years old at the time of consent/enrollment. Participants diagnosed with irritable bowel syndrome by a gastroenterologist at baseline evaluation, with residual symptoms after at least 3 months of usual care, and with residual symptoms of moderate severity or higher at baseline evaluation. Participants who meet Rome III or Rome IV criteria for irritable bowel disease. Participants who can basically avoid (as much as possible) any change in usual treatment for IBS from the time of enrollment to the end of treatment. Participants who are able and willing to make continuous visits to the site. However, due to the global expansion of covid-19, participants who are willing to participate in online group meetings on a regular basis will be allowed to participate even if they are unable to make continuous visits to the site after April 2020. Those who are able to communicate, read and write in Japanese. Those who understand the purpose and content of this study, and who are able to give written consent to participate in the study of their own free will.
Key exclusion criteria	Have received or are receiving other structured psychotherapy at the time of the baseline assessment Currently receiving psychiatric or psychosomatic treatment and deemed by the attending psychiatrist or psychosomatic physician to be ineligible for participation in this study. Patients who meet the diagnostic criteria for major depression on the Patient Health Questionnaire-9 (PHQ-9) at the baseline assessment, or who have had "more than half of the time in two weeks" of suicidal thoughts on item 9 of the PHQ-9. Pregnant women Participants who have been treated or are being treated for organic diseases Other participants who are judged by the principal investigator or research assistant investigator to be inappropriate as subjects of this study.
Target sample size	114

Research contact person
Name of lead principal investigator	1st name Shino Middle name Last name Kikuchi
Organization	Kyoto University
Division name	Graduate School of Medicine, Kyoto University
Zip code	6068315
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Email	suciri117@gmail.com

Public contact
Name of contact person	1st name Shino Middle name Last name Kikuchi
Organization	Kyoto University
Division name	Graduate School of Medicine, Kyoto University
Zip code	6068315
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Homepage URL
Email	suciri117@gmail.com

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

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	2022 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2022 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date	2022 Year 08 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study with pseudonymized data for UMIN000031710

Management information
Registered date	2022 Year 07 Month 04 Day
Last modified on	2022 Year 07 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055001

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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