Neuropsychological Sequelae and Long COVID-19 Fatigue

NCT05323318 | Unknown DMC

• 1 other identifier: 141/21
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Anxiety Depression; Post Traumatic Stress Disorder; Mental Fatigue; COVID-19; Fatigue Syndrome, Chronic

Keywords

SARS-CoV-2, fatigue, psychological disorders

Outcome Measures

Primary Outcomes (2)

• Prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety

  Fatigue will be assessed with the Chalder fatigue scale: \- 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

  6-9 months

• Prevalence of fatigue in patients with post-COVID-19 post-traumatic stress disorder

  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

  6-9 months

Secondary Outcomes (3)

• Impact of post-COVID-19 fatigue in quality of life.

  6-9 months

• Impact of post-COVID-19 neuropsychological sequelae in quality of life

  6-9 months

• Evaluate if neuropsychological are associated with severity of acute COVID-19

  6-9 months

Study Arms (2)

Neuropsychological Sequelae

Post-COVID-19 symptomatic patients with neuropsychological sequelae

Other: Neuropsychological Sequelae

Without Neuropsychological Sequelae

Post-COVID-19 symptomatic patients Without neuropsychological sequelae

Interventions

Neuropsychological Sequelae OTHER

Neuropsychological Sequelae after SARS-CoV-2 symtomatic infection

Neuropsychological Sequelae

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in five Portuguese Hospitals, Universitary and district, in which a follow-up post-COVID-19 medical consultation has been implemented

You may qualify if:

• ≥18 years;
• Previous COVID-19 at least six months after the diagnosis duly documented in the clinical record;
• Persistent symptoms after cure criteria defined by WHO Symptomatic patients that attend the post-COVID-19 follow-up consultation of the study centres.
• SARS-CoV-2 RNA confirmed by a positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab.
• SARS-CoV-2 antigen confirmed on a nasopharyngeal swab, by a healthcare professional.

You may not qualify if:

• Patients with PTSD previous diagnosis
• Severe psychiatric disorders documented in the clinical record
• Patients not able to respond the questionnaire
• Patients who had a concomitant severe neurological disorder
• Clinical and radiological diagnosis of Stroke with sequelae
• Clinical diagnosis of Alzheimer's Disease
• Clinical diagnosis of Parkinson's disease
• Patients with persistent fatigue symptoms in the 6 months before SARS-CoV 2 infection

Sponsors & Collaborators

• Centro Hospitalar Universitario do Algarve: lead
• Universidade do Algarve: collaborator
• Universidade do Porto: collaborator

Study Sites (6)

Hospital Particular de Alvor

Alvor, 8500-322, Portugal

RECRUITING

Hospital Professor Doutor Fernando Fonseca (Hff)

Amadora, 2720-276, Portugal

COMPLETED

Hospital de Faro (Chua)

Faro, 8000-386, Portugal

COMPLETED

Hospital de Portimao

Portimão, 8500-338, Portugal

RECRUITING

Hospital de Sao Sebastiao (Chedv)

Santa Maria da Feira, 4520-211, Portugal

RECRUITING

Hospital de Vila Franca de Xira (Hvfx)

Vila Franca de Xira, 2600-009, Portugal

SUSPENDED

Related Publications (7)

• 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.

  PMID: 23748906 BACKGROUND

• Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.

  PMID: 25559796 BACKGROUND

• 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. doi: 10.1016/0022-3999(93)90081-p.

  PMID: 8463991 BACKGROUND

• 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.

  PMID: 30285773 BACKGROUND

• Simani L, Ramezani M, Darazam IA, Sagharichi M, Aalipour MA, Ghorbani F, Pakdaman H. Prevalence and correlates of chronic fatigue syndrome and post-traumatic stress disorder after the outbreak of the COVID-19. J Neurovirol. 2021 Feb;27(1):154-159. doi: 10.1007/s13365-021-00949-1. Epub 2021 Feb 2.

  PMID: 33528827 RESULT

• Mazza MG, De Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, Melloni EMT, Furlan R, Ciceri F, Rovere-Querini P; COVID-19 BioB Outpatient Clinic Study group; Benedetti F. Anxiety and depression in COVID-19 survivors: Role of inflammatory and clinical predictors. Brain Behav Immun. 2020 Oct;89:594-600. doi: 10.1016/j.bbi.2020.07.037. Epub 2020 Jul 30.

  PMID: 32738287 RESULT

• Pires L, Reis C, Mesquita Facao AR, Moniri A, Marreiros A, Drummond M, Berger-Estilita J. Fatigue and Mental Illness Symptoms in Long COVID: Protocol for a Prospective Cohort Multicenter Observational Study. JMIR Res Protoc. 2024 Jan 19;13:e51820. doi: 10.2196/51820.

  PMID: 38241071 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Mental Fatigue; COVID-19; Fatigue Syndrome, Chronic; Fatigue; Mental Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Ligia Pires, MD

  Centro Hospitalar Universitario do Algarve

  STUDY CHAIR

• Joana Berger, PHD

  Universitat Bern

  STUDY DIRECTOR

• Ligia Pires, MD

  Centro Hospitalar Universitario do Algarve

  PRINCIPAL INVESTIGATOR

• Marta Drummond, PHD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ligia Pires, MD

CONTACT

+351282450300; alves1029@hotmail.com

Inês Simões, MD

CONTACT

+351282450300; inesgsimoes@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 12, 2022
• Study Start: April 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 30, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

PT (6)