UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048267 |
|---|---|
| Receipt number | 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 15:26:15 |
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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
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
suciri117@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055001
