UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048459 |
|---|---|
| Receipt number | R000055226 |
| Scientific Title | Pre- and post-comparative pilot study of the feasibility and safety of Internet-delivered cognitive behavioral therapy for irritable bowel syndrome |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/09/04 17:52:29 |
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Basic information
Public title
Remote Self-guided and Efficacious cognitive-behavioral Therapy for irritable bowel syndrome(ReSET):a pilot study
Acronym
Cognitive Behavioral Therapy Pilot Study for Irritable Bowel Syndrome (Reset Program)
Scientific Title
Pre- and post-comparative pilot study of the feasibility and safety of Internet-delivered cognitive behavioral therapy for irritable bowel syndrome
Scientific Title:Acronym
Pilot study on feasibility and safety of iCBT for IBS
Region
| Japan |
Condition
Condition
irritable bowel syndrome
Classification by specialty
| Hepato-biliary-pancreatic medicine | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
feasibility
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Irritable bowel syndrome severity and quality of life
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
ICT-based Cognitive Behavioral Therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 years of age or older.
Diagnosed with IBS at a medical facility and treated with medication for at least 3 months
Have residual symptoms of at least mild (IBS-SSS more than 75 points)
Meet Rome III or Rome IV IBS diagnostic criteria
Have regular access to the Internet
Able to read, write, and communicate in Japanese
Voluntary consent to participate in the study
Key exclusion criteria
Currently receiving other structured psychotherapy at the time of enrollment or plan to do so during the intervention period
Currently receiving psychiatric or psychosomatic treatment and deemed by the attending physician to be ineligible for participation in the study
Meet the diagnostic criteria for major depression on the PHQ-9 at the time of enrollment, or have "more than half of a week" of suicidal ideation on item 9 of the PHQ-9 at the time of enrollment
Pregnant women
Those who have been treated or are undergoing treatment for organic diseases of the abdomen or other parts of the body.
Anyone who is judged to be unsuitable for this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shino |
| Middle name | |
| Last name | Kikuchi |
Organization
Kyoto University Graduate School of Medicine
Division name
Faculty of Medicine
Zip code
6068315
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto 606-8501 JAPAN
TEL
+81750757539491
shino_k@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shino |
| Middle name | |
| Last name | Kikuchi |
Organization
Kyoto University Graduate School of Medicine
Division name
Faculty of Medicine
Zip code
6068315
Address
+81750757539491
TEL
+81750757539491
Homepage URL
suciri117@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
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 606-8501, JAPAN
Tel
+81757534680
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 | 10 | 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
132
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
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055226
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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