UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of cognitive neuroscientific effects of interoceptive training
Acronym	Interoceptive training
Scientific Title	Evaluation of cognitive neuroscientific effects of interoceptive training
Scientific Title:Acronym	Interoceptive training
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of the interoceptive training and its brain science characteristics.
Basic objectives2	Others
Basic objectives -Others	NA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change ratio of index of interoceptive awareness after 1 week interoceptive training
Key secondary outcomes	Brain MR Images

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	Interoceptive training task for 1 week
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)18 years old or older 2)A person who has the ability to agree by the person and can obtain informed consent. In the case of a minor, a guardian / support obligation person can check the explanatory document or the public announcement document. 3) At the time of agreement, it is likely to be able to participate in this research schedule which will last for one week
Key exclusion criteria	1) Those who have a serious physical disorder (for example, a bone fracture etc.) that interferes with study participation when participating in the study. 2) Those who receive ongoing treatment for mental and physical diseases at the time of study participation. 3) Those who do not use Japanese as their native language 4) Those who are pregnant 5) Those with metal or electronic equipment in the body and body surface 6) There is a possibility that metal fragments are mixed in the body 7) Those who have tattoos, those with art make 8) Those who engaged in the metal processing industry 9) Claude, dark place phobia In addition to the above, those who the doctor judged as ineligible for survey
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Sekiguchi
Organization	National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name	Department of Behavioral Medicine
Zip code	187-8553
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, JAPAN
TEL	042-341-2711
Email	asekiguchi@ncnp.go.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Sekiguchi
Organization	National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name	Department of Behavioral Medicine
Zip code	187-8553
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, JAPAN
TEL	042-341-2711
Homepage URL
Email	asekiguchi@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center of Neurology and Psychiatry
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, JAPAN
Tel	042-341-2711
Email	ml_rinrijimu@ncnp.go.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	2019 Year 07 Month 30 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 05 Month 07 Day
Date of IRB	2018 Year 05 Month 07 Day
Anticipated trial start date	2018 Year 09 Month 05 Day
Last follow-up date	2023 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	2019 Year 07 Month 30 Day
Last modified on	2019 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042812

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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