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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031710
Receipt No. R000035391
Scientific Title The Efficacy of Group Cognitive Behavior Therapy for Irritable Bowel Syndrome: Randomized Controlled Trial
Date of disclosure of the study information 2018/04/06
Last modified on 2018/09/12

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Basic information
Public title The Efficacy of Group Cognitive Behavior
Therapy for Irritable Bowel Syndrome:
Randomized Controlled Trial
Acronym Successful Use of CBT for IRrItable bowel syndrome (SUCIRI) project
Scientific Title The Efficacy of Group Cognitive Behavior
Therapy for Irritable Bowel Syndrome:
Randomized Controlled Trial
Scientific Title:Acronym Successful Use of CBT for IRrItable bowel syndrome (SUCIRI) project
Region
Japan

Condition
Condition irritable bowel syndrome
Classification by specialty
Medicine in general Gastroenterology Psychosomatic Internal Medicine
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessing efficacy and safety of group cognitive behavioral therapy for irritable bowel syndrome (at 13 week from the start of the study)

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.The Japanese version of the irritable bowel syndrome quality of life instrument(IBS-QOL-J)
2.The Japanese version of the irritable bowel syndrome-severity index(IBSSI-J)
Key secondary outcomes 1.Irritable Bowel Syndrome-Global Improvement Scale(Japanese:IBS-GIS)
2.EuroQol-5D-5L(Japanese:EQ-5D-5L)
3.Patient Health Questionnaire-9(Japanese:PHQ-9)
4.Generalized Anxiety Disorder-7(Japanese:GAD-7)
5.Gastrointestinal Symptom Rating Scale(Japanese:GSRS)
6.Dropout rate
7.Adverse Events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome (Once a week,90 minutes session,10 sessions)
Interventions/Control_2 waiting list
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.People diagnosed by gastroenterologist and have have moderate or severe symptoms remaining after receiving symptom-targeted pharmacotherapy for 3 months or more.
2.People diagnosed with irritable bowel syndrome based on the Rome III or Rome IV diagnostic criteria
3.People who basically do not change (as much as possible) usual treatment for IBS during the research
4.People who are capable of continuous hospital visits and motivated
5.People who can communicate, read and write in Japanese
6.Persons who can understand the purpose and content of this trial and give voluntary written informed consent
Key exclusion criteria 1.People who has received psychotherapies
2.People who are currently undergoing treatment in psychiatry or psychosomatic department and judged that psychiatry or psychosomatic medicine doctor is inappropriate for participation in this study
3.People who are suffering from sever anxiety disorders and depression or with suicidal attempt (using PHQ-9)
4.Pregnant women
5.People who is treated or under treatment due to organic disease of the abdomen
6.People whom the principal investigator has determined to be unsuitable as a participant of the study
Target sample size 112

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Furukawa
Organization Graduate school of Medicine and Faculty of Medicine Kyoto University
Division name Health Promotion and Human Behavior
Zip code
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL 075-753-9491
Email furukawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shino Kikuchi
Organization Graduate school of Medicine and Faculty of Medicine Kyoto University
Division name Health Promotion and Human Behavior
Zip code
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL 090-8377-8549
Homepage URL https://suciri.localinfo.jp/
Email suciri117@gmail.com

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Other
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Center for Cognitive Behavior Therapy and Research
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 京都大学医学部付属病院(京都府)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 06 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
2018 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 13 Day
Last modified on
2018 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035391

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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