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A study on selection of photographic stimuli to develop an integrated platform using brain activity information for the purpose of objective psychological measurement

Status Approved

First Submitted Date

2021/03/12
Registered Date

2021/03/24
Last Updated Date

2021/03/12

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006017
Unique Protocol ID	2020R1A4A1019623
Public/Brief Title	Survey Research: Selecting Emotional Trigger Images
Scientific Title	A study on selection of photographic stimuli to develop an integrated platform using brain activity information for the purpose of objective psychological measurement
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	1041078-202008-HRBM-231-01
Approval Date	2020-11-11
Institutional Review Board Name	Chung-Ang University Institutional Review Board
Institutional Review Board Address	84, Heukseok-ro, Dongjak-gu, Seoul
Institutional Review Board Telephone	02-820-6236
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Doug hyun Han
Title	Professor
Telephone	+82-2-6299-1508
Affiliation	Chung-Ang Univerisity Hospital
Address	84, Heukseok-ro, Dongjak-gu, Seoul
Contact Person for Public Queries
Name	Sujin Bae
Title	Research Professor
Telephone	+82-2-6299-1508
Affiliation	Chung-Ang University
Address	84, Heukseok-ro, Dongjak-gu, Seoul
Contact Person for Updating Information
Name	Sunhye Park
Title	Researcher
Telephone	+82-2-6299-1508
Affiliation	Chung-Ang University
Address	84, Heukseok-ro, Dongjak-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2020-11-19 Actual
Target Number of Participant	600
Primary Completion Date	2020-11-25 , Actual
Study Completion Date	2020-11-25 , Actual
Name of Study	Chung-Ang University
Recruitment Status	Completed
Date of First Enrollment	2020-11-19 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Science and ICT
Organization Type	Government
Project ID	2020R1A4A1019623

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Gachon University
Organization Type	University
2. Sponsor Organization
Organization Name	Chung-Ang University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Backgrouds Recently, there has been much research to measure human emotion exposing stimuli such as facial, situational or phonologica stimuli. The most widely used situational stimuli sets are: International Affective Picture System (IAPS; Lang et al., 2005), the Nencki Affective Picture System (NAPS; Marchewka et al., 2014), and the Geneva Affective Picture Database (GAPED; Dan-Glauser and Scherer, 2011). Purpose The purpose of this study is to select photographic stimuli to develop an integrated platform using brain activity information for the purpose of objective psychological measurement. The Artificial Intelligence(AI) methodology will be applied to achieve this purpose. Our main targets are three emotional stimuli: anger, anxiety, and depression-related photography. Methodology We will conduct a survey for this study. The participants are young male adults aged 19-30(college/university/graduate students). The recruiting will be performed via an advertisement in the online communities or a research company. We used two kinds of picture stimuli sets in this study: (1) emotional facial picture (sample size=100), (2) situational descriptive pictures (sample size=500). The participants will rate every emotion on a scale for anger, anxiety and depression(range from “0=not at all” to “10=extremly”) after seeing the pictures one by one. They also respond to a self-rating questionnaire to measure depression, anxiety, impulsivity, and aggression. The response data will be used to decide which picture induce stronger emotional arousal. The self-rating score will be used as a reference information.

Study Summary Information

Lay Summary

Backgrouds
Recently, there has been much research to measure human emotion exposing stimuli such as facial, situational or phonologica stimuli. The most widely used situational stimuli sets are: International Affective Picture System (IAPS; Lang et al., 2005), the Nencki Affective Picture System (NAPS; Marchewka et al., 2014), and the Geneva Affective Picture Database (GAPED; Dan-Glauser and Scherer, 2011).

Purpose
The purpose of this study is to select photographic stimuli to develop an integrated platform using brain activity information for the purpose of objective psychological measurement. The Artificial Intelligence(AI) methodology will be applied to achieve this purpose. Our main targets are three emotional stimuli: anger, anxiety, and depression-related photography.

Methodology
We will conduct a survey for this study. The participants are young male adults aged 19-30(college/university/graduate students). The recruiting will be performed via an advertisement in the online communities or a research company. We used two kinds of picture stimuli sets in this study: (1) emotional facial picture (sample size=100), (2) situational descriptive pictures (sample size=500). The participants will rate every emotion on a scale for anger, anxiety and depression(range from “0=not at all” to “10=extremly”) after seeing the pictures one by one. They also respond to a self-rating questionnaire to measure depression, anxiety, impulsivity, and aggression. The response data will be used to decide which picture induce stronger emotional arousal. The self-rating score will be used as a reference information.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-only
Time Perspective	Cross-sectional
Target Number of Participant	600
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Emotional Trigger Images - Facial expression
Cohort/ Group 1	Cohort/Group Description 100 persons [Conducting a survey: Rating degree of emotions of facial expression images] - Emotions: Depression, Anxitey, Anger - Score range: 0-10 [Conducting self rating scales of Depression, Anxitey, Impulsiveness, Aggression]
Cohort/ Group 2	Cohort/Group Label Emotional Trigger Images - Situations
Cohort/ Group 2	Cohort/Group Description 500 persons [Conducting a survey: Rating degree of emotions of various situation images] - Emotions: Depression, Anxitey, Anger - Score range: 0-10 [Conducting self rating scales of Depression, Anxitey, Impulsiveness, Aggression]
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Young male adult college/university/graduate students living in Korea between 19 and 30 years old
Sampling Method	▶ Survey 1. Emotional Trigger Images - Facial expression (n=100) Posting recruitment notices of research participants at college or university online communities, and recruiting. Posting recruitment notices of research participants at online communities that college or university students are the main visitors, and recruiting. ▶ Survey 2. Emotional Trigger Images - Situations (n=500) Recruiting survey participants through online research company Macromill Embrain Co., Ltd.
Condition(s)/Problem(s)	Not Applicable-Etc Not Applicable
Rare Disease	No
Inclusion Criteria	Gender Male
	Age 19Year~30Year
	Description -Males living in Korea between 19 and 30 years old -College or university or graduate students
Exclusion Criteria	-Person who did not agree to participate in the study -IQ less than 70 -Other cases classified as inappropriate by the researchers
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Average anger score of each image
Timepoint	Time point that the survey was conducted
Primary Outcome(s) 2
Outcome	Average anxitey score of each image
Timepoint	Time point that the survey was conducted
Primary Outcome(s) 3
Outcome	Average depression score of each image
Timepoint	Time point that the survey was conducted
Secondary Outcome(s) 1
Outcome	Beck Depressive Inventory (BDI)
Timepoint	Time point that the survey was conducted
Secondary Outcome(s) 2
Outcome	the Center for Epidemiologic Studies Depression scale (CES-D)
Timepoint	Time point that the survey was conducted
Secondary Outcome(s) 3
Outcome	Beck Anxiety Inventory (BAI)
Timepoint	Time point that the survey was conducted
Secondary Outcome(s) 4
Outcome	Generalized Anxiety Disorder-7 (GAD-7)
Timepoint	Time point that the survey was conducted
Secondary Outcome(s) 5
Outcome	Korean Adult ADHD Scale (K-AADHDS)
Timepoint	Time point that the survey was conducted
Secondary Outcome(s) 6
Outcome	Korean Barratt Impulsiveness Scale-11-Revised (K-BIS-11-R)
Timepoint	Time point that the survey was conducted
Secondary Outcome(s) 7
Outcome	Aggression Questionnaire(K-AQ)
Timepoint	Time point that the survey was conducted

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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