Post-acute sequelae of SARS-CoV-2 infection (PASC) Mental and Behavioural Disorders
Conditions
Interventions
Patients included in the study will be examined by FIS, A-PASC, AQoL, PHQ, GAD-7, and Clinical Global Impression (CGI) questionnaires to determine neuropsychiatric symptoms and the current symptom sev
Sponsors
Czech Health Research Council
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 10/11/2023: 1. Male and female outpatients aged 18-75 years with a history of COVID-19 and monitored by an outpatient physician for mental disorders (anxiety, mood disorders, sleep) within the PASC 2. PCR RNA SARS-CoV-2 negativity at screening/study entry 3. Duration of symptoms >1 and =24 months after detection of COVID-19 4. The mental ability to understand and sign the Informed Consent Form 5. Presence of neuropsychiatric PASC symptoms as determined by A-PASC with a minimum overall score =25 (cognitive score, emotional and functional impairment) 6. FIS questionnaire score =40 7. Psychopharmacological medication (if used) at a stable dose =4 weeks. Previous participant inclusion criteria: 1. Male and female outpatients aged 18-75 years with a history of COVID-19 and monitored by an outpatient physician for mental disorders (anxiety, mood disorders, sleep) within the PASC 2. PCR RNA SARS-CoV-2 negativity at screening/study entry 3. Duration of symptoms >1 and =18 months after detection of COVID-19 4. The mental ability to understand and sign the Informed Consent Form 5. Presence of neuropsychiatric PASC symptoms as determined by A-PASC with a minimum overall score =25 (cognitive score, emotional and functional impairment) 6. FIS questionnaire score =40 7. Psychopharmacological medication (if used) at a stable dose =4 weeks.
Exclusion criteria
Exclusion criteria: 1. Contraindications of tDCS (skin disease, superficial injury, and fracture or infraction of skull in the stimulation area, epilepsy, metallic plates in the head) 2. History of any other DSM-IV axis I diagnosis prior to COVID-19, except for: 2.1. Depressive disorders, anxiety disorders, and sleep disorders that may be present in the history, but with at least 6 months of documented remission of symptoms 2.2. Disorders associated with the use of addictive substances at least 6 months before entering the study 3. Pregnancy or breastfeeding 4. Patients with severe and/or unstable somatic disorders (cardiovascular disease, neoplasms, endocrinology disorders, etc) 5. Patients suffering from a serious neurological disorder (eg epilepsy, head injury with loss of consciousness)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 10/11/2023: Czech version of the “Fatigue Impact Scale“ (FIS) score after the acute phase of the study Previous primary outcome measure: Czech version of the “Fatigue Impact Scale“ (FIS) score after the acute phase of the study and after the 4W-FU | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 10/11/2023: 1. The change in the following measurements after the acute phase of the study and after the 4W-FU: 1.1. Functional ability, cognitive functions, and emotional symptoms subscales of the “Post-COVID-19 Symptoms Assessment Questionnaire” (A-PASC) 1.2. Self-assessment scales of depressive and anxiety symptoms (PHQ-9; GAD-7) 1.3. Cognitive testing focused on attention, working memory, and psychomotor pace 1.4. Quality of life monitoring based on the AQOL-6D questionnaire 2. Evaluation of tDCS side effects during tDCS treatment by the investigator 3. Electrophysiological (EEG) parameters associated with PASC and their changes after the intervention (specifically EEG and functional connectivity will be evaluated) Previous secondary outcome measure: 1. The change in the following measurements after the acute phase of the study and after the 4W-FU: 1.1. Functional ability, cognitive functions, and emotional symptoms subscales of the “Post-COVID-19 Symptoms Assessment Questionnaire” (A-PASC) 1.2. Self-assessment scales of depressive and anxiety symptoms (PHQ-9; GAD-7) 1.3. Cognitive testing focused on attention, working memory, and psychomotor pace 1.4. Quality of life monitoring based on the AQOL-6D questionnaire 2. Evaluation of tDCS side effects during tDCS treatment by the investigator 3. Electrophysiological (EEG) parameters associated with PASC and their changes after the intervention (specifically qEEG concordance, EEG microstates, and functional connectivity will be evaluated) | — |
Countries
Czech Republic
Outcome results
None listed