UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028702 |
|---|---|
| Receipt number | 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 20:40:41 |
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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
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
shino_k@kuhp.kyoto-u.co.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032075
