UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037548 |
|---|---|
| Receipt number | R000042812 |
| Scientific Title | Evaluation of cognitive neuroscientific effects of interoceptive training |
| Date of disclosure of the study information | 2019/07/30 |
| Last modified on | 2024/08/02 09:21:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
asekiguchi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
http:// www.umin.ac.jp
Publication of results
Published
Result
URL related to results and publications
https://bpsmedicine.biomedcentral.com/articles/10.1186/s13030-020-00179-7
Number of participants that the trial has enrolled
22
Results
It was confirmed that interoceptive training reduced anxiety, somatic symptoms, and enhancing rational decision making. Furthermore, it was confirmed that brain circuits based on the anterior insular cortex were strengthened.
Results date posted
| 2023 | Year | 08 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 05 | Day |
Baseline Characteristics
Healthy volunteers
Participant flow
Recruitment was conducted within Keio University, a joint research institute, and mainly students participated.
Adverse events
NA
Outcome measures
Brain activity at rest
Interoceptive accuracy
Psychological measures (anxiety, physical symptoms, personalitys, etc.)
Behavioral measure (rationality)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042812
