UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034117 |
|---|---|
| Receipt number | R000038883 |
| Scientific Title | Neural Mechanisms of Choosing Adaptive Emotion Regulation Strategies |
| Date of disclosure of the study information | 2018/09/13 |
| Last modified on | 2026/03/30 16:32:37 |
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Basic information
Public title
Neural Mechanisms of Choosing Adaptive Emotion Regulation Strategies
Acronym
Neural Mechanisms of Choosing Adaptive Emotion Regulation Strategies
Scientific Title
Neural Mechanisms of Choosing Adaptive Emotion Regulation Strategies
Scientific Title:Acronym
Neural Mechanisms of Choosing Adaptive Emotion Regulation Strategies
Region
| Japan |
Condition
Condition
stress
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify neural mechanisms of choosing adaptive emotion regulation strategies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
brain activation data scanned by fMRI
Key secondary outcomes
Multiple regression analysis to examine relation between brain activation data and the other data
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
choosing and doing adaptive emotion regulation strategies
Interventions/Control_2
doing adaptive emotion regulation strategies
Interventions/Control_3
waiting without doing nothing
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy right-handed Japanese
Key exclusion criteria
1. mental disorder, brain disorder, nerve disorder
2. using medicines which affect cognitive functions
3. over 16 CES-D points
4. participating in other experiments, participated in other experiments within 2 months
5. having metal in the body
6. claustrophobia
7. strong nearsightedness
8. left-handed
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Kawashima |
Organization
Tohoku University
Division name
Department of Functional Brain Imaging, Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-7988
fbi@grp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | IDAC, Tohoku University |
| Middle name | |
| Last name | Department of Functional Brain Imaging |
Organization
Tohoku University
Division name
Department of Functional Brain Imaging, Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-7988
Homepage URL
fbi@grp.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryomachi, Aobaku, Sendai
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.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
| 2018 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2076-3425/14/11/1077
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-3425/14/11/1077
Number of participants that the trial has enrolled
40
Results
Self-choice emotion regulation reduced stress better than forced-choice emotion regulation. The stress reduction was associated with decreases in the activation of the left opercular part of the inferior frontal gyrus.
Results date posted
| 2026 | Year | 03 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
forty participants who met the inclusion criteria
Participant flow
Participants performed self-choice emotion regulation, forced emotion regulation, and no emotion regulation (the control condition) while their brain activity was captured using a functional magnetic resonance imaging scanner. First, the participants were shown a stressful scenario. Secondly, they rated the stress they experienced. Thirdly, they performed self-choice or forced emotion regulation or did nothing. Finally, participants rated their stress level again.
Adverse events
not applicable
Outcome measures
value of stress, brain activation during performing emotion regulation strategies
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 09 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038883
