UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046625 |
|---|---|
| Receipt number | R000053148 |
| Scientific Title | Exploring Predictors of Emotional Change and Building a Prediction Model |
| Date of disclosure of the study information | 2022/04/20 |
| Last modified on | 2022/07/16 01:25:03 |
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Basic information
Public title
Exploring Predictors of Emotional Change and Building a Prediction Model
Acronym
Exploring Predictors of Emotional Change and Building a Prediction Model
Scientific Title
Exploring Predictors of Emotional Change and Building a Prediction Model
Scientific Title:Acronym
Exploring Predictors of Emotional Change and Building a Prediction Model
Region
| Japan |
Condition
Condition
depressive state / depression
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will focus on changes in emotions and elucidate the factors. We will also create a model to predict emotional changes.
Basic objectives2
Others
Basic objectives -Others
We compare the differences in emotional expression between human and avatar interviewers.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Emotional Change in the Russell Russell's circumplex model
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
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
The interviewee is the avatar.
Duration of the intervention is 10 days.
The amount of intervention is about 5 minutes.
The number of interventions is 20.
Frequency is twice a day.
Interventions/Control_2
Interviewer is a human.
Duration of the intervention is 10 days.
The amount of intervention is about 5 minutes.
The number of interventions is 20.
Frequency is twice a day.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Workers
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shotaro |
| Middle name | |
| Last name | Doki |
Organization
University of Tsukuba
Division name
Faculty of medicine
Zip code
3058575
Address
Tennodai 1-1-1, Tsukuba
TEL
0298536025
doki.s@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Doki |
Organization
University of Tsukuba
Division name
Faculty of Tsukuba
Zip code
3058575
Address
Tennodai 1-1-1, Tsukuba
TEL
0298536025
Homepage URL
doki.s@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Sojitz Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sojitz Corporation and DG Communications Co., Ltd.
Name of secondary funder(s)
Grants-in-Aid for Scientific Research (KAKENHI)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
Tel
0298536025
doki.s@md.tsukuba.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
| 2022 | Year | 04 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 01 | Month | 13 | Day |
Last modified on
| 2022 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053148
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
