UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034446 |
|---|---|
| Receipt number | R000039279 |
| Scientific Title | The evaluation of a one-day Acceptance and Commitment Therapy workshop and workbook for the people who have irritable bowel syndrome symptoms |
| Date of disclosure of the study information | 2018/10/12 |
| Last modified on | 2020/04/23 10:00:07 |
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Basic information
Public title
The evaluation of a one-day Acceptance and Commitment Therapy workshop and workbook for the people who have irritable bowel syndrome symptoms
Acronym
The evaluation of ACT for irritable bowel syndrome symptoms
Scientific Title
The evaluation of a one-day Acceptance and Commitment Therapy workshop and workbook for the people who have irritable bowel syndrome symptoms
Scientific Title:Acronym
The evaluation of ACT for irritable bowel syndrome symptoms
Region
| Japan |
Condition
Condition
irritable bowel syndrome
Classification by specialty
| Gastroenterology | Psychosomatic Internal Medicine | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is whether brief group Acceptance and Commitment Therapy workshop and workbook could demonstrate significant decrease in irritable bowel syndrome severity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Irritable bowel syndrome severity index (IBSSI-J)
measuring at before intervention, 2 month and 4 month later the workshop.
Key secondary outcomes
1.The Japanese version of the irritable bowel syndrome quality of life instrument (IBS-QOL-J)
2.Medical Outcome Study 36-item Short Form Health Survey (SF-36)
3.Beck Depression Inventory-Second Edition (BDI-2)
4.State Trait Anxiety Inventory (STAI)
5. The Japanese version of the Acceptance and Action Questionnaire-II
6. The Japanese version of the Cognitive Fusion Questionnaire
7. The Japanese version of the Five Facet Mindfulness Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
one-day workshop of Acceptance and Commitment Therapy and workbook of Acceptance and Commitment Therapy
Interventions/Control_2
Waiting
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.The score of IBSSI >= 75 at the screening survey.
2.Ability to both understand and agree with informed consent in Japanese
Key exclusion criteria
1.Participants who presently undergoing psychopharmacological, or psychological treatment for gastrointestinal or psychiatric disorder
2.Person in whom organic disease is suggested by the presence of warning symptom (anemia, inflammatory reactions, or fecal occult blood, Unexplained weight loss in past 6 months, Persons with a family history of colon cancer)
3.Persons observed to have significant suicidal ideation
4.Any other person whom the principal investigator has determined to be unsuitable as a participant of the study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Muto |
Organization
Doshisha university
Division name
Faculty of psychology
Zip code
6100394
Address
1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
TEL
0774658220
takamuto@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Ito |
Organization
Doshisha university
Division name
Graduate school of Psychology
Zip code
6100394
Address
1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
TEL
0774658220
Homepage URL
ekq1003@mail2.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
Funding Source
Organization
Doshisha 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
Doshisha University Research Ethics Committee
Address
1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
Tel
0752513158
ji-rinri@mail.doshisha.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
| 2018 | Year | 10 | Month | 12 | 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
| 2018 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 11 | Day |
Last modified on
| 2020 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039279
