PostCoV2Psy: Neuropsychological Sequelae and Long COVID-19 Fatigue
Study Details
Study Description
Brief Summary
An association of fatigue with post-viral neuropsychological disturbs has been reported. Among patients hospitalized with COVID-19 there is an increased incidence of anxiety and depression symptoms. In addition, a quarter of patients experience at least mild symptoms of acute post traumatic stress disorder. (Mazza, M. G. et al 2020). The prevalence of chronic fatigue syndrome had a correlation with post-traumatic stress disorder (PTSD) in a study conducted after the outbreak of the COVID-19 in Iran (Silmani et al, 2021), that showed 5.8% of subjects suffering from PTSD after 6 months of SARS-CoV-2 infection onset.
In this Study we propose to use a tool to quantify the degree of physical and psychological fatigue in post-COVID-19 patients, and assess the correlation of fatigue with the neuropsychiatric sequelae in hospitalized and non hospitalized patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study will address the neuropsychiatric sequelae that remain for at least 6 months after SARS-CoV-2 acute infection, as depression, anxiety and/or post-traumatic stress disorder.
The patiensts will be assessed at the post-COVID-19 outpatient clinics of six Portuguese Hospitals.
A set of structured questionnaires, including the Chalder Fatigue Scale, Anxiety and Depression Hospital Scale (HADS), Post-Traumatic Stress Syndrome14 Questions Inventory (PTSS-14) adapted to COVID-19 and the EuroQol 5-Dimensions (EQ-5D) will be provided to the patients at the medical consultation between the 6th and 9th month after the first PCR or antigen positive SARS-CoV-2 test.
Additional questions were added to these questionnaires, namely about the patient's background; sex and age, employment status, level of education, and previous diseases.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Neuropsychological Sequelae Post-COVID-19 symptomatic patients with neuropsychological sequelae |
Other: Neuropsychological Sequelae
Neuropsychological Sequelae after SARS-CoV-2 symtomatic infection
|
| Without Neuropsychological Sequelae Post-COVID-19 symptomatic patients Without neuropsychological sequelae |
Outcome Measures
Primary Outcome Measures
- Prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety [6-9 months]
Fatigue will be assessed with the Chalder fatigue scale: Binary score (0-11) cut off ≥ 4 points for a fatigue case. Global score (0-33), that also spans two dimensions-physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11). This is a Likert scoring system that allows for means and distributions to be calculated for both the global total as well as the two sub-scales. Depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale Depression HADS subscale scoring: Normal 0-7; Boderline abnormal 8-10; Abnormal 11-21 Anxiety HADS subscale scoring: Normal 0-7; Borderline 8-10; Abnormal 11-21
- Prevalence of fatigue in patients with post-COVID-19 post-traumatic stress disorder [6-9 months]
Fatigue will be assessed with the Chalder fatigue scale (global and binary score). PTSD will be assessed with the Post-Traumatic Stress Syndrome 14 Questions Inventory (PTSS-14) adapted to COVID-19: - Positive case between 46-98 points
Secondary Outcome Measures
- Impact of post-COVID-19 fatigue in quality of life. [6-9 months]
Fatigue will be assessed with the Chalder fatigue scale (binary score and global score). Quality of live will be assessed by the original EQ-5D questionnaire, that comprises two parts: - EQ-5D-3L, health state classification scheme of five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each having three alternatives (1= no problems, 2= moderate problems, and 3= severe problems). Calculating a single index score combines these five dimensions. The index value of a particular health state thus indicates the preference for being in that health state in relation to death, which has been set equal to 0 and best possible health (eg, no problems on any of the five items) which has been set to 1.0. - EQ VAS, a visual analog scale to health state ranging from 0 (worst possible health state) to 100 (best possible health state).
- Impact of post-COVID-19 neuropsychological sequelae in quality of life [6-9 months]
Evaluate if the positive cases for anxiety, depression and/or PTSD have lower quality of live (The tools will be the same of previous outcomes).
- Evaluate if neuropsychological are associated with severity of acute COVID-19 [6-9 months]
Depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale Depression HADS subscale scoring: Normal 0-7; Boderline abnormal 8-10; Abnormal 11-21 Anxiety HADS subscale scoring: Normal 0-7; Borderline 8-10; Abnormal 11-21 Posttraumatic Stress Symptoms-14 instrument, adapted in this protocol for COVID-19 survivors: - PTSS 14 scoring > 45 points Previous COVID-19 severity will be categorized as mild, moderate and severe.
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥18 years;
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Previous COVID-19 at least six months after the diagnosis duly documented in the clinical record;
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Persistent symptoms after cure criteria defined by WHO Symptomatic patients that attend the post-COVID-19 follow-up consultation of the study centres.
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SARS-CoV-2 RNA confirmed by a positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab.
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SARS-CoV-2 antigen confirmed on a nasopharyngeal swab, by a healthcare professional.
Exclusion Criteria:
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Patients with PTSD previous diagnosis
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Severe psychiatric disorders documented in the clinical record
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Patients not able to respond the questionnaire
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Patients who had a concomitant severe neurological disorder
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Clinical and radiological diagnosis of Stroke with sequelae
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Clinical diagnosis of Alzheimer's Disease
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Clinical diagnosis of Parkinson's disease
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Patients with persistent fatigue symptoms in the 6 months before SARS-CoV 2 infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Particular de Alvor | Alvor | Portugal | 8500-322 | |
| 2 | Hospital Professor Doutor Fernando Fonseca (Hff) | Amadora | Portugal | 2720-276 | |
| 3 | Hospital de Faro (Chua) | Faro | Portugal | 8000-386 | |
| 4 | Hospital de Portimao | Portimao | Portugal | 8500-338 | |
| 5 | Hospital Sao Joao (Chusj) | Porto | Portugal | 4200-319 | |
| 6 | Hospital de Sao Sebastiao (Chedv) | Santa Maria Da Feira | Portugal | 4520-211 | |
| 7 | Hospital de Vila Franca de Xira (Hvfx) | Vila Franca de Xira | Portugal | 2600-009 |
Sponsors and Collaborators
- Centro Hospitalar Universitario do Algarve
- Universidade do Algarve
- Universidade do Porto
Investigators
- Study Chair: Ligia Pires, MD, Centro Hospitalar Universitario do Algarve
- Study Director: Joana Berger, PHD, Universitat Bern
- Principal Investigator: Ligia Pires, MD, Centro Hospitalar Universitario do Algarve
- Principal Investigator: Marta Drummond, PHD, Universidade do Porto
Study Documents (Full-Text)
None provided.More Information
Publications
- Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53.
- Ferreira LN, Ferreira PL, Pereira LN, Oppe M. The valuation of the EQ-5D in Portugal. Qual Life Res. 2014 Mar;23(2):413-23. doi: 10.1007/s11136-013-0448-z. Epub 2013 Jun 8.
- Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168.
- Rasa S, Nora-Krukle Z, Henning N, Eliassen E, Shikova E, Harrer T, Scheibenbogen C, Murovska M, Prusty BK; European Network on ME/CFS (EUROMENE). Chronic viral infections in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). J Transl Med. 2018 Oct 1;16(1):268. doi: 10.1186/s12967-018-1644-y. Review.
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