UMIN-CTR Clinical Trial

Basic information
Public title	The examination of the effective Acceptance and Commitment Therapy-based bibliotherapy of Irritable bowel syndrome symptoms for university students.
Acronym	The examination of the effectiveness of ACT-based bibliotherapy of Irritable bowel syndrome
Scientific Title	The examination of the effective Acceptance and Commitment Therapy-based bibliotherapy of Irritable bowel syndrome symptoms for university students.
Scientific Title:Acronym	The examination of the effectiveness of ACT-based bibliotherapy of Irritable bowel syndrome
Region	Japan

Condition
Condition	Irritable bowel syndrome
Classification by specialty	Hepato-biliary-pancreatic medicine Psychosomatic Internal Medicine Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is whether Acceptance and Commitment Therapy-based bibliotherapy for university students who show IBS symptoms could demonstrate significant decrease in irritable bowel syndrome severity score.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Japanese version of the Irritable bowel syndrome severity index (IBSSI-J)
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

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Acceptance and Commitment Therapy based bibliotherapy
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 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	80

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, Doshisha university
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	2017 Year 06 Month 29 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	Terminated
Date of protocol fixation	2017 Year 05 Month 16 Day
Date of IRB	2017 Year 08 Month 10 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2019 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	2017 Year 06 Month 18 Day
Last modified on	2020 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031855