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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028702
Receipt No. R000032075
Scientific Title The efficacy and feasibility study of the Group Cognitive Behavioral Therapy program for Irritable Bowel Syndrome:open label pilot study
Date of disclosure of the study information 2017/10/01
Last modified on 2018/07/13

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Basic information
Public title The efficacy and feasibility study of the Group Cognitive Behavioral Therapy program for Irritable Bowel Syndrome:open label pilot study
Acronym An open label pilot study of the Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome
Scientific Title The efficacy and feasibility study of the Group Cognitive Behavioral Therapy program for Irritable Bowel Syndrome:open label pilot study
Scientific Title:Acronym An open label pilot study of the Group Cognitive Behavioral Therapy for Irritable Bowel Syndrome
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 To examine the efficacy and feasibility of group cognitive behavioral therapy for irritable bowel syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

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 Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Cognitive Behavioral Therapy for Irritable Bowel Syndrome (Once a week,90 minutes session,10 sessions)
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
16 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Persons diagnosed with irritable bowel syndrome based on the Rome III or Rome IV diagnostic criteria
2.Persons who can understand the purpose and content of this trial and give voluntary written informed consent
3.patients who continue to have moderate or severe symptoms after 3 months of medical management
4.Persons who never took psychological treatment for IBS in the past
Key exclusion criteria 1.Person in whom organic disease is suggested by the presence of warning symptoms**
2.Those who can not understand Japanese
3.Persons suffering from sever anxiety disorders and depression or with suicidal ideation (diagnose by PHQ-9)
4.Any other person whom the principal investigator has determined to be unsuitable as a participant of the study

**Warning symptoms list
1.Symptoms which first appeared after 50 years of age
2.Any rectal bleeding that has not undergone sufficient medical investigation (excluding that caused by known hemorrhoids)
3.Diarrhea predominant IBS in which no colonoscopy investigation has been conducted
4.Unexplained weight loss without a change in eating habits
5.Nocturnal symptoms sufficient to cause insomnia
6.The presence of warning symptoms (anemia, inflammatory reactions or fecal occult blood)
7.A medical history that makes evaluation of this study difficult. (Past and present)
8.Persons with a family history of colon cancer in a first or second degree relative (grandparents, parents, siblings or children)
Target sample size 15

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 075-753-9491
Homepage URL
Email shino_k@kuhp.kyoto-u.co.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education Culture SportsScience and Technology Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
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 高槻赤十字病院(大阪府)

Other administrative information
Date of disclosure of the study information
2017 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
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
2017 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 25 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 17 Day
Last modified on
2018 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032075

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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