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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Irritable Bowel Syndrome | ||
Classification by specialty |
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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
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 114 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |