A Database for Emotion Analysis Using Physiological and Psychological Assessment by 40FY

December 28, 2023 updated by: 40FY
A comprehensive study examining the physiological, emotional and psychological aspects of stress among Korean adults

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

A dataset for the analysis of affective states of Korean adults. Participants' facial and finger videos were recorded using a cell phone camera, while watching six emotion-eliciting video stimuli, each three minutes in length (two of each: neutral, positive, and negative). Participants were asked to rate their emotion and arousal in terms of arousal and valence levels. The ECG data were collected using a 1-lead ECG while watching the six emotion-eliciting video stimuli. Psychological assessments were conducted using self-administered scales measuring psychological status and personality.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research and Development Division, 40FY Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

We recruited Adults between the ages of 19 and 45 who can read fluently in Korean. All study participants understood the study procedures and provided written informed consent according to the Declaration of Helsinki.

Description

Inclusion Criteria:

  • Adults over the age of 19 and under the age of 45.

Exclusion Criteria:

  • Participants vulnerable to voluntary consent, such as those who have evidence of intellectual disability or traumatic brain injury
  • Participants who have difficulty reading and understanding Korean.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Community dwelling participants
Individuals between the ages of 19 and 45 in South Korea.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Schema Scale
Time Frame: Baseline
A 35-item questionnaire developed by 40FY for identifying 5-types of maladaptive schema types. The questionnaire consists of 5-point Likert scale. The Schema Scale was developed based on schema theory and other psychodynamic theories. The scale was developed by a certified psychiatrist and 3 clinical psychologists. A higher score for each factor means that the individual has more severe maladaptive psychological schemas.
Baseline
Perceived Stress Scale (PSS)
Time Frame: Baseline
The PSS is a 10-item scale that measures the perceived stress on a 5-point severity with higher scores indicating more severe perceived stress.
Baseline
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Baseline
The CES-D is a 20-item questionnaire that measures depressive symptoms on a 4-point likert scale.
Baseline
State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline
The STAI is a 40-item inventory that measures state and trait anxiety. Higher score means higher anxiety.
Baseline
Beck Anxiety Inventory (BAI)
Time Frame: Baseline
A 21-item self-inventory on a 4-point likert scale measuring common somatic and cognitive symptoms of anxiety.
Baseline
Depression, Anxiety, and Stress Scale (DASS-21)
Time Frame: Baseline
The DASS-21 scale is an abbreviated version of the 42-item DASS test to measure depression, anxiety, and stress. It consists of seven items for each domain and is rated on a 4-point Likert scale.
Baseline
Self-Assessment Manikin Scale (SAM)
Time Frame: Baseline
The SAM consists of five pictures, with reference points between the pictures, which are rated on a 9-point scale. Participants are asked to mark their emotion and arousal on the picture closest to their emotional state. Six emotion-eliciting video stimuli (2 neutral, 2 negative, and 2 positive) are given, and individuals rate emotion and arousal right after watching each video stimuli.
Baseline
Heart-rate variability indices (SDNN, RMSSD, LF, HF)
Time Frame: Baseline
Measured from 1-lead ECG device. SDNN is the standard deviation of the NN interval. It is an indicator of the stability of the cardiovascular system and the responsiveness of the heart rhythm. RMSSD is the root mean square value of the variation of consecutive NN intervals, which indicates the activity of mainly parasympathetic nerves. The ECG data were collected by 1-lead ECG while watching 6 emotion-eliciting video stimuli.
Baseline
Five Factor Model of Personality Short Form Test (IPIP-NEO-120)
Time Frame: Baseline
The five factor model of personality is the most widely accepted and used personality based on trait theory. IPIP-NEO-120 has been developed to reduce the number of questions to 120 while maintaining the structure of 30 sub-facets comprising 5 factors of the 300-item. The shortened version has been reported to have high validity and reliability.
Baseline
Screening for Anxiety Disorders in Adults (SCAARED)
Time Frame: Baseline, Follow-up
A 44-item, 3-point Likert scale, self-report questionnaire developed as a screening test for anxiety disorders in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Items from the Screen for Children Anxiety Related Disorders (SCARED) was adapted for the adult version and validated a appropriate for screening for anxiety disorders.
Baseline, Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
40FY

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Woori Moon, MD, PhD, 40FY, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEAP-40FY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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