Psychological StressNCT06172673
A Database for Emotion Analysis Using Physiological and Psychological Assessment by 40FY
An observational study of Psychological Stress and Heart Rate Variability, run by 40FY at 1 site in South Korea.
Trial summary
A comprehensive study examining the physiological, emotional and psychological aspects of stress among Korean adults Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Heart Rate Variability, Mental Health Services
- How many people
- 119 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jul 2023to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Adults over the age of 19 and under the age of 45.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
A comprehensive study examining the physiological, emotional and psychological aspects of stress among Korean adults
Read the 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.
- Keywords
- Contactless measurement of Heart Rate Variability, Mobile digital mental health monitoring, Psychological assessment
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Community dwelling participants | Individuals between the ages of 19 and 45 in South Korea. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
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.
Measured: Baseline
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is a 20-item questionnaire that measures depressive symptoms on a 4-point likert scale.
Measured: Baseline
State-Trait Anxiety Inventory (STAI)
The STAI is a 40-item inventory that measures state and trait anxiety. Higher score means higher anxiety.
Measured: Baseline
Beck Anxiety Inventory (BAI)
A 21-item self-inventory on a 4-point likert scale measuring common somatic and cognitive symptoms of anxiety.
Measured: Baseline
Five Factor Model of Personality Short Form Test (IPIP-NEO-120)
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.
Measured: Baseline
Schema Scale
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.
Measured: Baseline
Depression, Anxiety, and Stress Scale (DASS-21)
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.
Measured: Baseline
Screening for Anxiety Disorders in Adults (SCAARED)
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.
Measured: Baseline, Follow-up
Self-Assessment Manikin Scale (SAM)
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.
Measured: Baseline
Heart-rate variability indices (SDNN, RMSSD, LF, HF)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start19 Jul 2023
- Primary completion8 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- 40FY
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woori Moon, MD, PhD, Principal investigator, 40FY, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172673
- Sponsor's protocol ID
- DEAP-40FY
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Database for Emotion Analysis Using Physiological and Psychological Assessment by 40FY
- ClinicalTrials.gov ID
- NCT06172673
- Acronym / sponsor ID
- DEAP-40FY
- Keywords
- Contactless measurement of Heart Rate Variability, Mobile digital mental health monitoring, Psychological assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- 40FYIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comprehensive study examining the physiological, emotional and psychological aspects of stress among Korean adults
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community dwelling participants | – | –Individuals between the ages of 19 and 45 in South Korea. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Adults over the age of 19 and under the age of 45.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woori Moon, MD, PhD principal investigator
40FY, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Stress and Heart Rate Variability, run by 40FY at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS) (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.