UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048267
Receipt No. R000055001
Scientific Title Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome A Cost-Utility Analysis: Results from a Randomized Controlled Trial
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.