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.
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
- Conditions the study is for
- Anxiety Depression, Post Traumatic Stress Disorder, Mental Fatigue
- 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
- Recruiting
Hospital Particular de Alvor
Alvor, 8500-322
ANA FONTES, PHD, 282420400, anafontes@grupohpa.com
Ligia Pires, MD
- Completed
Hospital Professor Doutor Fernando Fonseca (Hff)
Amadora, 2720-276
- Completed
Hospital de Faro (Chua)
Faro, 8000-386
- Recruiting
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
- Suspended
Hospital de Vila Franca de Xira (Hvfx)
Vila Franca de Xira, 2600-009
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).
- Conditions
- Anxiety Depression, Post Traumatic Stress Disorder, Mental Fatigue, COVID-19, Fatigue Syndrome, Chronic
- 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 group | Role | What they receive |
|---|---|---|
| Neuropsychological Sequelae | Post-COVID-19 symptomatic patients with neuropsychological sequelae Receives: Other: Neuropsychological Sequelae | |
| Without Neuropsychological Sequelae | Post-COVID-19 symptomatic patients Without neuropsychological sequelae |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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.
- First posted12 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Universitario do Algarve
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Algarve, Universidade do Porto
- Responsible party
- Principal investigator, Ligia Pires, Centro Hospitalar Universitario do Algarve
- Investigators
- Ligia Pires, MD, Study chair, Centro Hospitalar Universitario do AlgarveJoana Berger, PHD, Study director, Universitat BernLigia Pires, MD, Principal investigator, Centro Hospitalar Universitario do AlgarveMarta Drummond, PHD, Principal investigator, Universidade do Porto
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 23748906Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.
PubMed 25559796Chalder 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 8463991Rasa 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 30285773Simani 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 33528827Mazza 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 32738287Pires 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Sequelae as a Risk Factor for Long COVID-19 Fatigue
- ClinicalTrials.gov ID
- NCT05323318
- Acronym / sponsor ID
- PostCoV2Psy / 141/21
- Conditions
- Anxiety Depression, Post Traumatic Stress Disorder, Mental Fatigue, COVID-19, Fatigue Syndrome, Chronic
- Keywords
- SARS-CoV-2, fatigue, psychological disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centro Hospitalar Universitario do AlgarveUniversity, hospital or other
- Collaborators
- Universidade do Algarve, Universidade do Porto
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuropsychological Sequelae | – | Other: Neuropsychological SequelaePost-COVID-19 symptomatic patients with neuropsychological sequelae |
| Without Neuropsychological Sequelae | – | –Post-COVID-19 symptomatic patients Without neuropsychological sequelae |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- 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
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological SequelaeNeuropsychological Sequelae after SARS-CoV-2 symtomatic infection | Other | Neuropsychological Sequelae |
Primary outcome
Prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety
Time frame: 6-9 months
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
Prevalence of fatigue in patients with post-COVID-19 post-traumatic stress disorder
Time frame: 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
3 secondary outcomes
Impact of post-COVID-19 fatigue in quality of life.
Time frame: 6-9 months
Impact of post-COVID-19 neuropsychological sequelae in quality of life
Time frame: 6-9 months
Evaluate if neuropsychological are associated with severity of acute COVID-19
Time frame: 6-9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Background: PubMed 23748906Ferreira 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.
- Background: PubMed 25559796Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.
- Background: PubMed 8463991Chalder 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.
- Background: PubMed 30285773Rasa 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.
- Results publication: PubMed 33528827Simani 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.
- Results publication: PubMed 32738287Mazza 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.
- Derived from this study: PubMed 38241071Pires 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ligia Pires, MD study chair
Centro Hospitalar Universitario do Algarve
Joana Berger, PHD study director
Universitat Bern
Ligia Pires, MD principal investigator
Centro Hospitalar Universitario do Algarve
6 sites in 1 country: see every site and its status.
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.