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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034446
Receipt No. 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 2019/05/04

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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
Middle name
Last name Takashi Muto
Organization Doshisha university
Division name Faculty of psychology
Zip code
Address 1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
TEL 0774658220
Email takamuto@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Ito
Organization Doshisha university
Division name Graduate school of Psychology
Zip code
Address 1-3 Miyakodani, Tatara, Kyotanabe, Kyoto
TEL 0774658220
Homepage URL
Email ekq1003@mail2.doshisha.ac.jp

Sponsor
Institute Doshisha University
Institute
Department

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
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

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 Enrolling by invitation
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
2019 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039279

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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