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

NCT06172673 | Completed DMC

• 1 other identifier: DEAP-40FY
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psychological Stress; Heart Rate Variability; Mental Health Services

Keywords

Contactless measurement of Heart Rate Variability; Mobile digital mental health monitoring; Psychological assessment

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• State-Trait Anxiety Inventory (STAI)

  The STAI is a 40-item inventory that measures state and trait anxiety. Higher score means higher anxiety.

  Baseline

• Beck Anxiety Inventory (BAI)

  A 21-item self-inventory on a 4-point likert scale measuring common somatic and cognitive symptoms of anxiety.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline

Study Arms (1)

Community dwelling participants

Individuals between the ages of 19 and 45 in South Korea.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• 40FY: lead

Study Sites (1)

Research and Development Division, 40FY Inc.

Seoul, South Korea

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Woori Moon, MD, PhD

  40FY, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: July 19, 2023
• Primary Completion: December 8, 2023
• Study Completion: December 15, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)