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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030928
Receipt No. R000035325
Scientific Title Effect of attention bias modification on event-related potentials in patients with irritable bowel syndrome.
Date of disclosure of the study information 2018/01/22
Last modified on 2018/01/22

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Basic information
Public title Effect of attention bias modification on event-related potentials in patients with irritable bowel syndrome.
Acronym Effect of ABM on ERP in IBS.
Scientific Title Effect of attention bias modification on event-related potentials in patients with irritable bowel syndrome.
Scientific Title:Acronym Effect of ABM on ERP in IBS.
Region
Japan

Condition
Condition irritable bowel syndrome
Classification by specialty
Medicine in general Gastroenterology Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hypothesis of this study, abnormality of attention of IBS that the event-related potential as an indicator will be normalized after the ABM implementation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes event related potential
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 attention bias modification
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
19 years-old <=
Age-upper limit
25 years-old >=
Gender Male and Female
Key inclusion criteria irritable bowel syndrome
Key exclusion criteria a)history and current suspicion of psychosis disorder; (b) a serious psychiatric condition such as suicidal ideation, self-harm behavior, or severe dissociation.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Tayama
Organization Nagasaki University
Division name Graduate School of Education
Zip code
Address 1-14, Bunkyo, Nagasaki
TEL +81-95-819-2397
Email jtayama@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Tayama
Organization Nagasaki University
Division name Graduate School of Education
Zip code
Address 1-14, Bunkyo, Nagasaki
TEL +81-95-819-2397
Homepage URL
Email jtayama@nagasaki-u.ac.jp

Sponsor
Institute Graduate School of Education, Nagasaki University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 01 Month 22 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
As a result of the group comparison at the time of P100 latency at P4, the difference of the latency of the IBS group and the non-IBS group was seen in session 1, it was not seen in session 5(last session). In conclusion, by the practice of the ABM to the IBS, normalize brain function associated with the attention was found.
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
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 22 Day
Last modified on
2018 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035325

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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