Depression and Anxiety in Long Term Coronavirus Disease COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anxiety
- COVID-19
- Depression
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Method : Prospective Longitudinal study for 6 months. with both exposed and unexposed group Target population : A cohort of the population in multiple centers (3 centers) Sample Size Calculation with Longitudinal study formula: Effect Size: 0.15 Type I error: 0.05 Power of Study: 80% Number of Group...
Method : Prospective Longitudinal study for 6 months. with both exposed and unexposed group Target population : A cohort of the population in multiple centers (3 centers) Sample Size Calculation with Longitudinal study formula: Effect Size: 0.15 Type I error: 0.05 Power of Study: 80% Number of Group: 2 Repeated measurement: 3 times Correlation among Repeated Measures: 0.5 Nonsphericity Correction: 1 Initial Sample size: 75 Adjusted by clustering effect: Intraclass Correlation Coefficient = 0.05 Number of people per cluster = 25 Design Effect= 1 + 0.05(25-1) = 2.2 Total sample size = 75 x 2.2 = 165 participants Procedure: Participants will be assessed for eligibility Screening for Depression, Anxiety, and Stress using Depression Anxiety Stress Scale (DASS) Questionnaire. Health-Related Quality of Life (QoL) and Pittsburgh Sleep Quality Index (PSQI) Sample Collection and assessment of QoL, DASS, PSQI on the first day Sample Collection and assessment of QoL, DASS, PSQI on day 60 Sample Collection and assessment of QoL, DASS, PSQI on day 120 Variables Case Definition: Realtime Polymerase Chain Reaction (RT-PCR) and Cycle Threshold Value (CT) Degree of COVID 19 Symptom-based on World Health Organization Criteria (Asymptomatic, Mild, Moderate, Severe, Critical) Sociodemographic Variables (Age, Gender, Education, Income, Marital Status) Sleep Quality using Pittsburgh Sleep Quality Index (PSQI) Treatment of COVID: Antiviral, Antibiotic, Interleukin-6 Antagonist, Steroid, Plasma Convalescent, Ventilator, Human Intravenous Immunoglobulin, anticoagulant Chronic Disease including Diabetes Mellitus, Hypertension, Chronic Kidney Disease Medication that affects neurotransmitter level taken prior to recruitment. History of Smoking classified by Brinkmann Index. Body Mass Index Complete Blood Count Vaccination history Outcome Dopamine Serum Serotonin Serum Prevalence of Anxiety, and Depression according to Diagnostic and Statistical Manual of Mental disorders (DSM) 5 Statistical analysis Basic Analysis: Intention to Treat analysis Linear Mixed Model for Neurotransmitter Generalized Estimating Equation for Prevalence of Anxiety and Depression Sensitivity analysis will be conducted, concerning the lost-to-follow up A subgroup analysis will be conducted, particularly the participants with specific comorbidities
Tracking Information
- NCT #
- NCT04893668
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Bumi Herman, M.D Ph.D Chulalongkorn University