development of skin adhesive patches for the monitoring and prediction of mental disorders
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, South Korea
RECRUITINGElectrodermal activity(EDA)
changes of skin conductane level(SCL) and skin conductance response(SCR)
Time frame: baseline, 0.5, 1,2,3 months
Heart rate variability
changes of SDNN, RMSSD and LF/HF ratio
Time frame: baseline, 0.5, 1,2,3 months
Brain-derived neurotrophic factor(BDNF) genotyping: Val66Met
Time frame: baseline, 0.5, 1,2,3 months
Cytokines
IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12(p70), IFN-γ, TNF-α
Time frame: baseline, 0.5, 1,2,3 months
Leptin
Time frame: baseline, 0.5, 1,2,3 months
Adiponectin
Time frame: baseline, 0.5, 1,2,3 months
Epinephrine
Time frame: baseline, 0.5, 1,2,3 months
Norepinephrine
Time frame: baseline, 0.5, 1,2,3 months
C reactive protein
Time frame: baseline, 0.5, 1,2,3 months
BDNF
serum, plasma, platelet BDNF
Time frame: baseline, 0.5, 1,2,3 months
MINI plus
structured interview assessing for DSM-IV Axis I disorders with strong reliability and validity in relation to the Structured Clinical Interview for DSM-IV (SCID-IV)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline
MINI Suicidality Module
assess current and past Axis I diagnoses
Time frame: baseline, 0.5, 1,2,3 months
Hamilton Depression Rating Scale-17(HAMD-17)
changes of HAMD-17 total socres
Time frame: baseline, 0.5, 1,2,3 months
Hamilton Anxiety Rating Scale(HAMA)
changes of HAMA total scores
Time frame: baseline, 0.5, 1,2,3 months
Anxiety Sensitivity Index(ASI)
ASI-3 to measure the three most supported AS domains: social (i.e., fear of exhibiting symptoms in public that may elicit embarrassment), cognitive (i.e., fear of losing cognitive control or experiencing concentration difficulties), and physical (i.e., fear that physical sensations are a sign of an immediate physical problem).
Time frame: baseline, 0.5, 1,2,3 months
APPQ(Albany Panic and Phobia Questionnaire)
The APPQ (Rapee et al., 1995) is a 27-item instrument that is designed to measure interoceptive, agoraphobic, and social situational fear. Subjects respond to each item on a 9-point Likert scale from 0 to 8, according to how much fear they think they would experience in a given situation so that total scores range from 0 to 216.
Time frame: baseline, 0.5, 1,2,3 months
PSWQ(Penn state worry questionnaire)
16-item questionnaire that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me)
Time frame: baseline, 0.5, 1,2,3 months
SRI(Stress response Inventory)
emotional, somatic, cognitive, and behavioral stress responses.
Time frame: baseline, 0.5, 1,2,3 months
Perceived Stress Scale(PSS)
The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful.
Time frame: baseline, 0.5, 1,2,3 months
Barratt Impulsivity Scale
The Barratt Impulsiveness Scale (BIS) is a widely used measure of impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness).The BIS-11 is a 30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors.
Time frame: baseline, 0.5, 1,2,3 months
Panic disorder severity scale(PDSS)
The items assess panic frequency, distress during panic, panic-focused anticipatory anxiety, phobic avoidance of situations, phobic avoidance of physical sensations, impairment in work functioning, and impairment in social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. The total scores range from 0 to 28.
Time frame: baseline, 0.5, 1,2,3 months