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

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 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

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

Value
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