UMIN-CTR Clinical Trial

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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