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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06172673
Other study ID # DEAP-40FY
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 19, 2023
Est. completion date December 15, 2023

Study information

Verified date December 2023
Source 40FY
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A comprehensive study examining the physiological, emotional and psychological aspects of stress among Korean adults


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.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date December 15, 2023
Est. primary completion date December 8, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Locations

Country Name City State
Korea, Republic of Research and Development Division, 40FY Inc. Seoul

Sponsors (1)

Lead Sponsor Collaborator
40FY

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. Baseline
Primary State-Trait Anxiety Inventory (STAI) The STAI is a 40-item inventory that measures state and trait anxiety. Higher score means higher anxiety. Baseline
Primary Beck Anxiety Inventory (BAI) A 21-item self-inventory on a 4-point likert scale measuring common somatic and cognitive symptoms of anxiety. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline, Follow-up
Primary 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. Baseline
Primary 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. Baseline
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