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Anxiety DepressionPostCoV2PsyNCT05323318

Neuropsychological Sequelae and Long COVID-19 Fatigue

An observational study of Anxiety Depression and Post Traumatic Stress Disorder, run by Centro Hospitalar Universitario do Algarve at 6 sites in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 95 years
What is being tested?
Neuropsychological Sequelae
How many people
200 participants
Where
6 sitesPortugal
Study dates
1 Apr 2022to 30 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • ≥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.

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Portugal6 sites, 3 recruiting
  • Hospital Particular de Alvor

    Alvor, 8500-322

    ANA FONTES, PHD, 282420400, anafontes@grupohpa.com

    Ligia Pires, MD

    Recruiting
  • Hospital Professor Doutor Fernando Fonseca (Hff)

    Amadora, 2720-276

    Completed
  • Hospital de Faro (Chua)

    Faro, 8000-386

    Completed
  • Hospital de Portimao

    Portimão, 8500-338

    Ligia S Pires, MD, +351282450300 ext. 35115, alves1029@hotmail.com

    Inês Simões, MD, +351282450300 ext. 43066, inesgsimoes@gmail.com

    Recruiting
  • Hospital de Sao Sebastiao (Chedv)

    Santa Maria da Feira, 4520-211

    Ana Sofia Barroso, MD, +351 256 379 700, anasofiabarroso@gmail.com

    Jorge Ferreira, Prof, +351 256 379 700, pneumologia@chedv.min-saude.pt

    Recruiting
  • Hospital de Vila Franca de Xira (Hvfx)

    Vila Franca de Xira, 2600-009

    Suspended

Other trials in Portugal

About this study

Official title: Neuropsychological Sequelae as a Risk Factor for Long COVID-19 Fatigue

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.

Read the 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 five Portuguese Hospitals. In the first visit (T1) will be collected the demographic characteristics; the medical history; and the screening of acute disease symptoms and severity. In the second visit (T2), the time frame will be at least 6 months after the positive test and no longer than 9 months, a set of structured questionnaires will be provided, including: the Chalder Fatigue Scale, Anxiety and Depression Hospital Scale (HADS), The Posttraumatic Stress Symptoms-14 (PTSS-14) adapted to COVID-19 and the EuroQol 5-Dimensions (EQ-5D).

Being tested
Neuropsychological Sequelae
Keywords
SARS-CoV-2, fatigue, psychological disorders
Medical subject headings
Stress Disorders, Post-Traumatic, Mental Fatigue, COVID-19, Fatigue Syndrome, Chronic, Fatigue, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuropsychological SequelaeOther

    Neuropsychological Sequelae after SARS-CoV-2 symtomatic infection

Study groups in NCT05323318
Study groupRoleWhat they receive
Neuropsychological SequelaePost-COVID-19 symptomatic patients with neuropsychological sequelae
Receives: Other: Neuropsychological Sequelae
Without Neuropsychological SequelaePost-COVID-19 symptomatic patients Without neuropsychological sequelae

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6-9 months

  2. 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

    Measured: 6-9 months

Secondary outcomes (3)
  1. Impact of post-COVID-19 fatigue in quality of life.

    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).

    Measured: 6-9 months

  2. Impact of post-COVID-19 neuropsychological sequelae in quality of life

    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).

    Measured: 6-9 months

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

    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

    Acute COVID-19 severity will be categorized as mild illness (mild symptoms without the radiographic appearance of pneumonia), pneumonia (having symptoms and the radiographic evidence of pneumonia, with no requirement for supplemental oxygen), severe pneumonia (having pneumonia, including one of the following: respiratory rate > 30 breaths/minute; severe respiratory distress; or SpO2 ≤ 93% on room air at rest), and critical cases (e.g. respiratory failure requiring mechanical ventilation or nasal high flow oxygen, septic shock, other organ failure occurrence or admission into the ICU).

    Measured: 6-9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start1 Apr 2022
  3. Primary completion30 Mar 2023 (estimated)
  4. Study completion30 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323318
Sponsor's protocol ID
141/21
Acronym
PostCoV2Psy
Status last verified
Mar 2023
First submitted
8 Apr 2022
Last updated
14 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23748906
  • Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.

    PubMed 25559796
  • 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.

    PubMed 8463991
  • 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.

    PubMed 30285773
  • 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.

    PubMed 33528827
  • 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.

    PubMed 32738287
  • 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.

    PubMed 38241071

Questions about this trial

What is this clinical trial studying?

An observational study of Anxiety Depression and Post Traumatic Stress Disorder, run by Centro Hospitalar Universitario do Algarve at 6 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ligia Pires, MD (+351282450300 ext. 43168, alves1029@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety (time frame: 6-9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05323318, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.

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