UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023374 |
|---|---|
| Receipt number | R000026932 |
| Scientific Title | Neural basis for Cognitive Bias Modification for Interpretation |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2016/07/28 16:39:00 |
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Basic information
Public title
Neural basis for Cognitive Bias Modification for Interpretation
Acronym
Neural basis for Cognitive Bias Modification for Interpretation
Scientific Title
Neural basis for Cognitive Bias Modification for Interpretation
Scientific Title:Acronym
Neural basis for Cognitive Bias Modification for Interpretation
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understanding neural basis for cognitive bias modification for interpretation
Basic objectives2
Others
Basic objectives -Others
Basic natural science
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regional brain activity changes correlated to increase of positive interpretation of ambiguous social situations
Key secondary outcomes
Social anxiety, Depression, Personality traits
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Imagining ambiguous social scenarios followed positive outcome, ~1 hour/day, 4 days/2 weeks
Interventions/Control_2
Imagining consistently positive social scenarios, ~1 hour/day, 4 days/2 weeks
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy university students, Social anxiety tendency (More than 17 points of Fear of Negative Evaluation Scale)
Key exclusion criteria
MRI contraindication
Auditory inability
left handedness
Past history of neurological illness
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta Kawashima |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
Address
Seiryo-machi 4-1, Aoba-ku, Sendai 980-8575
TEL
022-717-7988
fbi@idac.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Sakaki |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
Address
Seiryo-machi 2-1, Aoba-ku, Sendai 980-8575
TEL
022-717-8585
Homepage URL
kohei.sakaki.q1@dc.tohoku.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
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
| 2016 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | 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
| 2016 | Year | 07 | Month | 28 | Day |
Last modified on
| 2016 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026932
