Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug513 | Brief Psychiatric Rating Scale Wiki | 0.22 |
drug726 | Change in preference to surgery under COVID-19 pandemic. Wiki | 0.22 |
drug512 | Brief Interpersonal Telepsychotherapy Wiki | 0.22 |
Name (Synonyms) | Correlation | |
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drug3663 | aerosol box Wiki | 0.22 |
drug840 | Connor-Davidson Resilience Scale 10 items (CD-RISC 10) Wiki | 0.22 |
drug1663 | Intervention App Wiki | 0.22 |
drug1235 | Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki | 0.22 |
drug1222 | Exposure to the SARS-CoV-2 Wiki | 0.22 |
drug3655 | [68Ga]Ga-DOTA-(RGD)2 PET/CT Wiki | 0.22 |
drug2189 | Non applicable Wiki | 0.22 |
drug3636 | Zaritt Burden Interview Wiki | 0.22 |
drug2804 | Respiratory and psychological rehabilitation Wiki | 0.22 |
drug3956 | pre_lunch Yoga-based breathing support Wiki | 0.22 |
drug3293 | Telepsychoeducation Wiki | 0.22 |
drug410 | Berberine Wiki | 0.22 |
drug638 | COVID19 immunization testing Wiki | 0.22 |
drug784 | Cognitive Behavioral Brief-Telepsychotherapy Wiki | 0.22 |
drug853 | Control Group (pharmacotherapy and/or psychotherapy, n=10) Wiki | 0.22 |
drug3615 | Withings ScanWatch Wiki | 0.22 |
drug2931 | SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales Wiki | 0.22 |
drug3415 | Transitional Online Peer Support Group (n=20) Wiki | 0.22 |
drug4059 | transparent sheet Wiki | 0.22 |
drug2676 | Quantitative and qualitative assessments of mental health Wiki | 0.22 |
drug3955 | pre_dinner Yoga-based breathing support Wiki | 0.22 |
drug2336 | PHQ-9 (9-item Patient Health Questionnaire) Wiki | 0.22 |
drug992 | Depression, Anxiety and Stress Scale Wiki | 0.22 |
drug2427 | Phone-call screening and management by a medical student/general practitioner tandem Wiki | 0.22 |
drug445 | Biological: COVID-19 convalescent plasma Wiki | 0.22 |
drug3882 | morning Yoga-based breathing support Wiki | 0.22 |
drug713 | Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies Wiki | 0.22 |
drug2352 | PSS (Perceived Stress Scale) Wiki | 0.22 |
drug2179 | No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests Wiki | 0.22 |
drug1602 | Impact of Event Scale-Revised Wiki | 0.22 |
drug2047 | Montmorrillonite Wiki | 0.22 |
drug994 | Description of groups caracteristics Wiki | 0.22 |
drug1223 | Exposure to the SARS-CoV-2 and its consequences Wiki | 0.22 |
drug1318 | GAD-7 (7-item Generalized Anxiety Disorder) Wiki | 0.22 |
drug3403 | Training session adressing information and health literacy Wiki | 0.22 |
drug3676 | anti-SARS-CoV-2 convalescent plasma Wiki | 0.11 |
drug2276 | Online Survey Wiki | 0.10 |
Name (Synonyms) | Correlation | |
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D000066553 | Problem Behavior NIH | 0.44 |
D011618 | Psychotic Disorders NIH | 0.31 |
D004194 | Disease NIH | 0.26 |
Name (Synonyms) | Correlation | |
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D013001 | Somatoform Disorders NIH | 0.22 |
D011602 | Psychophysiologic Disorders NIH | 0.22 |
D002908 | Chronic Disease NIH | 0.10 |
D009461 | Neurologic Manifestations NIH | 0.09 |
D013313 | Stress Disorders, Post-Traumatic NIH | 0.08 |
D002318 | Cardiovascular Diseases NIH | 0.07 |
D001008 | Anxiety Disorders NIH | 0.07 |
D012120 | Respiration Disorders NIH | 0.05 |
D040921 | Stress Disorders, Traumatic NIH | 0.04 |
D012140 | Respiratory Tract Diseases NIH | 0.04 |
D013315 | Stress, Psychological NIH | 0.04 |
D016638 | Critical Illness NIH | 0.03 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
D018352 | Coronavirus Infections NIH | 0.02 |
D007239 | Infection NIH | 0.01 |
Name (Synonyms) | Correlation | |
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HP:0000708 | Behavioral abnormality HPO | 0.44 |
HP:0000709 | Psychosis HPO | 0.31 |
HP:0001626 | Abnormality of the cardiovascular system HPO | 0.07 |
Navigate: Correlations HPO
There are 21 clinical trials
Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). Accordingly, this prospective (0, 3, 6 and 12 months), multisite cohort study aims to describe, examine, and evaluate the impact of the Covid-19 pandemic on mental health and social factors among workers at health services from Latin America and the Caribbean, Europe and neighboring countries, the Middle East and North Africa, as well as Sub-Saharan Africa and Asia. Additionally, a team from the United States of America will also participate in this collaborative effort providing expertise on psychiatric epidemiology and supporting coordination across countries.
Description: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries
Measure: Anxiety and depressive symptoms Time: 12 monthsDescription: Ad hoc survey on experiences, fears, and concerns about Covid-19
Measure: Experiences, fears and concerns about the Covid-19 Time: BaselineDescription: Ad hoc survey on experiences, fears, and concerns about Covid-19
Measure: Experiences, fears and concerns about the Covid-19 Time: 3 monthsDescription: Ad hoc survey on experiences, fears, and concerns about Covid-19
Measure: Experiences, fears and concerns about the Covid-19 Time: 6 monthsDescription: Ad hoc survey on experiences, fears, and concerns about Covid-19
Measure: Experiences, fears and concerns about the Covid-19 Time: 12 monthsDescription: Ad hoc survey on Covid-19 training and resource prioritization
Measure: Training and resource prioritization Time: BaselineDescription: Ad hoc survey on Covid-19 training and resource prioritization
Measure: Training and resource prioritization Time: 3 monthsDescription: Ad hoc survey on Covid-19 training and resource prioritization
Measure: Training and resource prioritization Time: 6 monthsDescription: Ad hoc survey on Covid-19 training and resource prioritization
Measure: Training and resource prioritization Time: 12 monthsDescription: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Measure: Suicide ideation (presence) Time: BaselineDescription: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Measure: Suicide ideation (presence) Time: 3 monthsDescription: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Measure: Suicide ideation (presence) Time: 6 monthsDescription: Item from the Columbia Suicide Severity Rating Scale (C-SSRS) that measures suicidal ideation with a dichotomous answer (presence/absence)
Measure: Suicide ideation (presence) Time: 12 monthsDescription: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Measure: Suicide ideation (frequency) Time: BaselineDescription: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Measure: Suicide ideation (frequency) Time: 3 monthsDescription: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Measure: Suicide ideation (frequency) Time: 6 monthsDescription: 5-point Likert item from the Columbia Suicide Severity Rating Scale (C-SSRS). Higher scores indicate higher frequency.
Measure: Suicide ideation (frequency) Time: 12 monthsDescription: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
Measure: Acute stress symptoms Time: BaselineDescription: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
Measure: Acute stress symptoms Time: 3 monthsDescription: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
Measure: Acute stress symptoms Time: 6 monthsDescription: Ad hoc 3-item survey to evaluate acute stress disorder. Higher values of the 5-points Likert scales suggest higher frequency of symptoms
Measure: Acute stress symptoms Time: 12 monthsDescription: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support
Measure: Psycho/social support and network Time: BaselineDescription: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support
Measure: Psycho/social support and network Time: 3 monthsDescription: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support
Measure: Psycho/social support and network Time: 6 monthsDescription: Ad hoc survey on support network. The answers to the multiple items will be adjusted so higher values indicate higher levels of psychological and social support
Measure: Psycho/social support and network Time: 12 monthsDescription: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.
Measure: Resilience Time: BaselineDescription: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.
Measure: Resilience Time: 3 monthsDescription: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.
Measure: Resilience Time: 6 monthsDescription: The Brief Resilience Scale (BRS) is a 6-item self-reported instrument that measures resilience. The range of scores is 6-30. Higher scores indicate higher resilience levels.
Measure: Resilience Time: 12 monthsDescription: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries
Measure: Anxiety and depressive symptoms Time: BaselineDescription: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries
Measure: Anxiety and depressive symptoms Time: 3 monthsDescription: The 12-item version of the General Health Questionnaire (GHQ-12) is a self-reported instrument that measures symptoms of anxiety and depression. It provides cut-off points to identify people at risk of anxiety and/or depression, which differ slightly between countries
Measure: Anxiety and depressive symptoms Time: 6 monthsStudy the impact of containment related to COVID-19 pandemic on psychotic experiences in the general population in France.
Description: The CAPS is a 32-item self-report scale designed to measure perceptual anomalies and hallucinatory experience that has already been validated in clinical and nonclinical populations. Each of the 32 items involves a question related to a specific hallucinatory experience to which the participant can answer 'yes' or 'no'. If the participant answers 'yes' they are asked to rate how distressing, how intrusive and how often the experience occurs on separate 1-5 rated Likert scales. The scale total is calculated as the total number items responded to with 'yes' (possible range 0-32) and the subscale totals are calculated as the total of the subscale items (possible range 0-160)
Measure: Total score of the Cardiff Anomalous Perceptions Scale (CAPS) Time: inclusion, 1 week after inclusion and 1 month after inclusionDescription: Paranoia Scale : this self-report scale is widely used in the assessment of paranoia in the general population. The scale is comprised of a set of 20 items, answered in a Likert-like scale ranging from 1 (never) to 5 (always). Scores can vary between 20 and 100, where higher scores indicate greater paranoid ideation
Measure: Paranoia Scale Time: inclusion, 1 week after inclusion and 1 month after inclusionDespite being originated in Wuhan, in the China mainland region of the Hubei, Italy has been the hardest-hit country in the world by the COVID-19 pandemic during the month of March. Due to the uncontrollable spread of the contagion, the Italian Government has been forced to impose a series of restrictions and social distancing measures, culminating in the extension of lockdown to the entire Italian territory on March 8th. During this period, the general population has been overwhelmed by feelings of worry, anxiety, and discomfort. The discomfort is reinforced by the lengthening of the lockdown, to the point that it may be considered as a mass model of chronic or subchronic mild stress. The predictable effects of this stress on mental health have already been claimed, Post-traumatic symptoms were found in 7% among 285 Wuhan and surrounding cities' residents during the COVID-19 outbreak. A recent survey in the Italian general population reported similar outcomes. In this context, the psychic conditions of the most fragile ones, i.e. those already affected by a severe mental disorder, represent a major concern. Having a history of psychiatric illness is regarded as one of the most relevant predictors of a negative psychological impact of quarantine. Patients with severe mental disorders may be among the hardest hit subjects, as they may be more vulnerable by the COVID-19 outbreak for a series of clinical and psychological factors. In the Italian context, the vulnerability of these patients may be increased by the lockdown of mental health services as a consequence of mass quarantine and optimization of health resources toward action to contrast COVID-19-related sanitary emergencies. Despite several reports investigated the psychological effects of COVID-19 pandemic on health-care workers, COVID-19 affected people, or the general population, at the moment, no study has investigated the effects of the distress caused by fear of contagion and mass quarantine on severe mental disorder patients. The present study aimed at providing a first evaluation of anxiety, depressive, stress-related symptoms in these patients.
Description: Significant differences among groups in the mean Perceived Stress Scale (PSS) score, which measures the stress severity perceived by the subjects in the last month. The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 40. Higher total scores indicate a worse outcome
Measure: Perceived Stress Scale (PSS) outcome Time: 10 daysDescription: Significant differences among groups in the mean Generalized Anxiety Disorder (GAD-7) scale score, which measures anxiety symptoms' severity in the last two weeks. The scale is constituted by 7 items that are self-rated by the subject on a 0-3 Likert scale. The scale minimum total score is 0, the maximum is 21. Higher total scores indicate a worse outcome
Measure: Generalized Anxiety Disorder (GAD-7) scale outcome Time: 10 daysDescription: Significant differences among groups in the mean Patient Health Questionnaire (PHQ-9) scale score, which measures depressive symptoms' severity in the last two weeks. The scale is constituted by 9 items that are self-rated by the subject on a 0-3 Likert scale. The scale minimum total score is 0, the maximum is 21. Higher total scores indicate a worse outcome
Measure: Patient Health Questionnaire (PHQ-9) scale outcome Time: 10 daysDescription: Significant differences among groups in the mean Specific Psychotic Experiences Questionnaire (SPEQ) - Paranoia subscale score. The SPEQ scale is designed for the assessment of current sub-threshold psychotic symptoms in multiple domains. The Paranoia subscale measures persecutory/reference ideas and is constituted by 15 items that are self-rated by the subject on a 0-5 Likert scale. The subscale minimum total score is 0, the maximum is 75. Higher total scores indicate a worse outcome
Measure: Specific Psychotic Experiences Questionnaire (SPEQ) - Paranoia subscale outcome Time: 10 daysDescription: Significant differences among groups in the mean Specific Psychotic Experiences Questionnaire (SPEQ) - Grandiosity subscale score. The Grandiosity subscale measures grandiosity/megalomaniac ideas and is constituted by 8 items that are self-rated by the subject on a 0-3 Likert scale. The subscale minimum total score is 0, the maximum is 24. Higher total scores indicate a worse outcome
Measure: Specific Psychotic Experiences Questionnaire (SPEQ) - Grandiosity subscale outcome Time: 10 daysDescription: Significant correlations between mean Zarit Burden Interview (ZBI) and mean scores on the Perceived Stress Scale (PSS). The ZBI is designed for the assessment of caregiver burden. The scale is constituted by 22 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 88. Higher total scores indicate a worse outcome
Measure: Caregiver Burden Time: 10 daysGiven the possible risks and complications of a comorbidity between psychiatric disorder and coronavirus disease 2019 (COVID-19), it seems particularly important to specify the impact of the COVID-19 pandemic in patients with psychiatric disorders and suspected of infection, hospitalized in a specific unit, at the psychiatric, somatic and pharmacological level.
Description: total severity score from the Impact of Event Scale-Revised (IES-R)
Measure: impact of the COVID-19 pandemic on psychiatric symptomatology Time: through study completion, an average of 2 yearFollowing the announcement of the containment of the population due to the COVID-19 epidemic on March 17, 2020 in France, a notable decrease in the number of consultations in general practice was reported. Patients no longer contact their general practitioner, including those with regular follow-up for one or more chronic conditions. This observation raised worries since it could lead to delay or failure in detecting decompensations / complications of these chronic conditions by a lack of recourse to care. Thus, an urgent message from the National Health Department (Direction Générale de la Santé - DGS) was adressed on April 8, 2020 to the health professionals regarding the organization of care aside from COVID-19. The main recommendation was "that the personal physician or the corresponding specialist should contact the most fragile patients with chronic condition to ensure follow-up and detect any risk of decompensation ". Such fragile patients are in great numbers, up to more than 200 for an average general practitioner. Therefore, although this recommendation is regarded as "essential in view of the health needs of the population", it will prove quite difficult to follow without the help of a skilled external assistance that can be quickly mobilized. The COVIQUEST project is a cluster randomized trial in general practice designed to assess the optimizationg of the screening and management of patients with chronic condition at risk of decompensation through a collaboration between the general practitioner and a medical student. The trial will focus on patients wit cardiovascular conditions aged 70 or more and patients with mental health conditions. These conditions are both highly prevalent in general practice and both at risk of severe short-term complications. Practices will be randomly assigned to a group (A or B). In group A, students will start by contacting patients with cardiovascular conditions; in group B they will start by contacting patients patients with mentral health conditions. The students will call these patients on the phone and ask them specific questions about their health, their needs, and if they want their general practitioner to call them back. The student will then transmit this information to the general practitioner who will decide on the best care to offer the patient. The primary outcome is defined as the occurrence of hospitalization during a one-month period after the phone call. It will be collected by a second phone call from the medical student. This time, all patients will be contacted, i.e. both patients with mental illness and cardiovascular patients, whatever the group. Thus, patients allocated to the control groups (i.e. patients with mental illness from group A and cardiovascular patients from group B) will also benefit from the intervention at 1 month: again, students will ask patients about their health and whether they want their general practitioner to call them back. This approach has several advantages: 1. all patients will benefit from a phone call, in accordance with the recommendations of the DGS, 2. the involvement of students, competent in medical interviews and quickly mobilizable, will help general practitioners, on the front line of many missions, without any health risk linked to the contagiousness of COVID-19 for students, 3. randomizing the call order will allow to assess with a high level of evidence the impact of such an organization on hospitalizations, for two families of diseases with high prevalence. The trial will involve at least nine French regions. Considering that the general practitioner's patient base numbers an average of 110 patients with chronic cardiovascular disease or chronic mental illness, and that at least 25 general practitioners per region participate in the study, we can expect that 22,000 patients will benefit from the intervention of this study.
Description: Hospitalization over a one month period. The primary outcome will be collected by a phone call from a medical student to the patient 1 month after randomization date. Hospitalizations (date, location, length, if available, and reason) will be collected. Because there will be many patients to be called for each practitioner, we expect these phone call to occur within a few days after day 28.
Measure: Hospitalization(s) at 1 month Time: 1 monthDescription: In the experimental group only: proportion of patients for whom the practitioner had to call back after the medical student had phoned (just after allocation of the practice to the experimental group) at 1 month.
Measure: Phone-call from the general practitioner (in the experimental group only) Time: 1 monthDescription: Mortality will be reported after checking with the city of the patient's home if there is no response to the phone call
Measure: Mortality at 1 month Time: 1 monthDescription: Number of general practitioner consultations and teleconsultations (and time of general practitioner consultation, i.e. during the containment period or not) using data from the French Health National (SNDS) Database
Measure: Use of primary care Time: 6 monthsDescription: Number of consultations with another medical specialist (and time of consultation, i.e. during the containment period or not) using data from the French Health National (SNDS) Database
Measure: Use of secondary care Time: 6 monthsDescription: Number of prescriptions related to the chronic disease that were dispensed by the pharmacy using data from the French Health National (SNDS) Database
Measure: Number of prescriptions related to the chronic disease dispensed by the pharmacy Time: 6 monthsDescription: Number of hospitalizations using data from the French Health National (SNDS) Database
Measure: Number of hospitalization(s) Time: 6 monthsDescription: Time to hospitalization using data from the French Health National (SNDS) Database
Measure: Time to hospitalization(s) Time: 6 monthsDescription: Hospitalization duration using data from the French Health National (SNDS) Database
Measure: Hospitalization(s)' durations Time: 6 monthsDescription: Reason for hospitalization using data from the French Health National (SNDS) Database
Measure: Reasons for hospitalization(s) Time: 6 monthsDescription: Number of deaths using data from the French Health National (SNDS) Database
Measure: Mortality at 6 months Time: 6 monthsDescription: Only for patients in the COVIQuest_CV sub-trial: Cardiovascular events (MACE): nonfatal stroke, nonfatal myocardial infarction, cardiovascular death and hospitalization for heart failure using data from the French Health National (SNDS) Database
Measure: Cardiovascular events (MACE) Time: 6 monthsDescription: Only for patients in the COVIQuest_MH sub-trial: Psychotropic drugs consumption using data from the French Health National (SNDS) Database
Measure: Psychotropic drugs Time: 6 monthsCovid-19 pandemic now affects more than two million people worldwide. The neurotropism of the virus is assumed by its frequent association with neurological symptoms (anosmia, ageusia, headaches) but the extent of the central or peripheral nervous system involvement and the associated symptomatology remain poorly known for now. The main objective of this study is to describe the neurological and psychiatric manifestations occurring in the context of Covid-19 infection in patients hospitalized or followed-up in the APHP.SU hospital group. A better understanding of the neuropsychiatric impairment related to Covid-19 would improve the management of these patients in the acute phase, and knowledge of subsequent complications would allow adapting their rehabilitation and follow-up. The precise phenomenological description of these manifestations and the imaging, biology and neuropathology data will be compiled from the data collected by the physicians in charge of these patients as part of their inpatient or outpatient care. This study will also allow collecting unusual clinical manifestations from patients followed for neurological or psychiatric pathology in hospital departments and presenting a Covid-19 infection, in order to optimize the reorganization of their management, follow-up and rehabilitation in the epidemic context.
Description: Frequency of central or peripheral neurological or psychiatric symptoms observed in patients with COVID-19
Measure: Central or peripheral neurological symptoms or psychiatric symptoms observed in patients with Covid-19 Time: 12 monthsDescription: Impact on neurological or psychiatric disease trajectories assessed by severity scores or subjective progression (improved, stable, impaired) during and after COVID-19 pathology in patients with pre-existing neurological and psychiatric diseases
Measure: Progression of pre-existing neurological or psychiatric pathologies Time: 12 monthsA dynamic analytical tool is being implemented to monitor the health, psychosocial and economic impacts of the COVID-19 pandemic as the crisis unfolds. A longitudinal survey is distributed via a network of hospitals, provincial/national organizations and web platforms. The survey information can be linked to provincial health administrative data and metrics derived from social media activity based on artificial intelligence methods. Targeted questions are included for critical populations such as healthcare workers and people with chronic illnesses.
Description: Cohen's Perceived Stress Scale (scores ranged from 0 to 40, higher scores indicating worse stress)
Measure: Mental health - Stress Time: through study completion, estimated to 8 monthsDescription: Generalized Anxiety Disorder Scale (scores ranged from 0 to 21, higher scores indicating worse anxiety)
Measure: Mental health - Anxiety Time: through study completion, estimated to 8 monthsDescription: Quick Inventory of Depressive Symptomatology-Self-report, short version (scores ranged from 0 to 27, higher scores indicating worse depression)
Measure: Mental health - Depression Time: through study completion, estimated to 8 monthsDescription: Measure of Moral Distress - Healthcare Professionals (scores ranged from 0 to 432, higher scores indicating worse moral distress)
Measure: Moral distress in healthcare workers Time: through study completion, estimated to 8 monthsDescription: Rushton Moral Resilience Scale (scores ranged from 1 to 4, higher scores indicating more resiliency)
Measure: Moral resilience in healthcare workers Time: through study completion, estimated to 8 monthsDescription: Frequency of interacting with other people (daily, weekly, monthly, less often than monthly)
Measure: Social life Time: through study completion, estimated to 8 monthsDescription: Fever, Cough, Difficulty breathing or shortness of breath, Tiredness, Aches and pains, Nasal congestion, Runny nose, Sore throat, Diarrhea (Mild Moderate, Severe, N/A)
Measure: COVID-9 symptoms Time: through study completion, estimated to 8 monthsDescription: Mortality (Yes/No): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
Measure: Adverse health long-term outcome Time: 5 years before the outbreak and two years afterDescription: Hospitalizations (total number): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
Measure: Health care utilization - Inpatient Time: 5 years before the outbreak and two years afterDescription: Emergency Department visits (Total number): https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
Measure: Health care utilization - ER Time: 5 years before the outbreak and two years afterDescription: Outpatient visits: https://datadictionary.ices.on.ca/Applications/DataDictionary/Default.aspx
Measure: Health care utilization - Outpatient Time: 5 years before the outbreak and two years afterDescription: Pittsburgh Sleep Quality Index (scores ranged from 0 to 21, higher scores indicating worse sleep disturbances)
Measure: Sleep Time: through study completion, estimated to 8 monthsThe main objective of this multicenter cohort study is to determine the degree of COVID19 infection immunization of a population of psychiatric patients. The secondary objective of this cohort follow-up is to: 1. Clinically characterize COVID patients who are positive for serological testing 2. Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis 3. Immunologically characterize COVID patients who are positive for serological testing 4. Exploring the links between susceptibility to COVID19 and erythrocytic blood groups
Description: Number of COVID-positive patients, defined by a positive serological test result by immuno-chromatography at inclusion or at 15 days.
Measure: Number of COVID-positive patients Time: day 15France has been put on a lockdown for 8 weeks to prevent the spread of the COVID-19 virus between 17/03/2020 and 11/05/2020. During this lockdown, which is likely to have psychopathological repercussions on the population, the public authorities and the media informed the population about the number of deaths occurring each day. While the functioning of autobiographical memory following traumatic events remains a debate in the literature, the impact of the daily announcement of mass deaths on the memory system in the general population and the relationship between long-term memory and delusional thinking in certain psychopathologies have yet to be explored in the literature. The investigators wish to demonstrate that self-reported recall of recorded deaths may represent this distortion of perception, symptomatic of these pathologies by an on-line questionnaire.
Description: number of perception distortions
Measure: number of perception distortions Time: 1 dayDescription: Recall number of deaths
Measure: Recall number of deaths Time: 1 dayThis study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain. The intervention will consist in psychoeducation, delivered via a mobile App. Participants will be followed up during two weeks. The primary outcome will be symptomatology of depression, anxiety or stress.
Description: Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)
Measure: Depression, anxiety and stress Time: 2 weeksDescription: Davidson Trauma Scale (DTS). The DTS is a 17-item, Likert-scale, self-report instrument that assesses the 17 DSM-IV symptoms of PTSD. Both a frequency and a severity score can be determined. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). Higher scores are indicative a worse outcome.
Measure: Post-traumatic stress syndrome Time: 2 weeksDescription: Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)
Measure: Insomnia Time: 2 weeksDescription: General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)
Measure: Self Efficacy Time: 2 weeksThe overall objective of this study is to assess the enormity of mental health outcomes among healthcare providers (nurses and physicians) exposed to COVID-19 during the time of the pandemic in the United States, specifically targeting those areas most effected.
Description: The Impact of Event Scale - Revised (IES-R). IES-R is a 22-item scale with possible scores ranging from 0 - 88. Scores higher than 24 are of concern indicating possible health and well-being consequences.
Measure: Emotional Impact Time: 7 daysDescription: Patient Health Questionaire (PHQ-9). The PHQ-9 has a range from 0 - 27. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.
Measure: Depression Time: 2 weeksDescription: Generalized Anxiety Disorder 7-item (GAD-7). Scores range from 0 - 21. When screening for anxiety disorders, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.
Measure: Anxiety Time: 2 weeksDescription: The ISI7 is a 7-item instrument designed to assess the nature, severity, and impact of insomnia in adults. Scores range from 0 - 28. Higher scores indicate increased likelihood of sleep disturbances.
Measure: Insomnia Time: 1 weekDescription: Brief Resilience Scale (BRS) is a 6-item scale with scores ranging from 6-30 with higher scores indicating greater resilience.
Measure: Resilience Time: 2 WeeksDescription: The Crisis Support Scale (CSS) is a 7-item instrument developed to measure received social support. Scores range from 7 - 98, with higher scores correlating with increased social support.
Measure: Crisis Support Scale Time: 2 weeksThe aim of this study is to measure current affective symptoms and psychological distress in individuals with severe mental illness during the COVID-19 pandemic using an online questionnaire survey. In addition, this study aims at identifying individual beliefs, sleep quality, attitudes concerning the virus, the adherence to the measures, believing processes, and coping strategies/resilience patterns referring to COVID-19 in different study centers.
Description: Brief Symptom Inventory-18 with higher scores meaning a worse outcome (more depression, anxiety and somatization); Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 72)
Measure: Global symptom load (Anxiety, Somatisation, Depression, Global Symptom Index) Time: 1 yearDescription: Beck Depression Inventory-II with higher scores mean a worse Outcome (more depressive Symptoms; each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)
Measure: Depressive symptoms Time: 1 yearDescription: Pittsburgh Sleep Quality Index (PSQI) with higher scores mean a worse Outcome (more sleeping disturbances; Each item is weighted on a 0-3 interval scale; Minimum = 0, Maximum = 63)
Measure: Sleep disorders and Sleep Quality Time: 1 yearDescription: Lifestyle Questions including physical activity, eating behavior, substance use, smoking
Measure: Life style changes Time: 1 yearDescription: Food Craving Inventory (FCI) with higher scores mean a worse Outcome (more Food craving; Each item is weighted on a 0-4 interval scale; Minimum = 0, Maximum = 112)
Measure: Food Craving Time: 1 yearDescription: COVID-19 questionnaire with higher scores meaning a worse Outcome (more fears and negative emotions; each item is weighted on a 0-10 interval scale)
Measure: COVID-19 associated fears and emotional responses to the pandemic Time: 1 yearCOronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs mainly from immunological behavior or by suicide after healing . In both cases, the causal link is coronavirus within the host response. The rationale of use of deep yoga breathing as adjuvant treatment to COVID-19 disease , is linked to the mechanical action to stimulate the vagus nerve through scalene and sternocleidomastoid muscles function of which the continuity of action bring to modulate upto suppress, the inflammatory reflex and pro-inflammatory cytokines overproduction and contextual lowering of the sympathetic stress response as a first cause of sleep and late mental disorders which can increase the annual suicide rate. An easily breathing medical Yoga protocol has been developed to test a cost-effective care provision, training, contact tracing and mass efficacy testing.
Description: COVID-19's Patients mortality all cause: incidence proportion.
Measure: Mortality Time: 12 months.Description: COVID-19's Patients suicide: incidence proportion.
Measure: Mortality-suicide Time: 12 months.Description: In-hospital COVID-19's Patients oxygen invasive ventilation or high flow oxygen devices :incidence proportion of Brescia COVID-19 respiratory Severity Scale Index (Levels 0-3 worse outcome) cutoff Level ≥ 2 -
Measure: Incidence of hospitalization for respiratory failure of COVID-19's Patients- Time: 1 months.Description: Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.
Measure: Incidence of al home professional psychiatric-psychological interventions for mental disorder. Time: 12 months.Description: Scoring system for depression and anxiety requiring drugs treatment: incidence proportion of BDI-II aggregate components score 0- 63 ( worse outcome) , cutoff > 29.
Measure: Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II). Time: 12 months.Description: Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff > 8.
Measure: Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI). Time: 12 months.The actual worldwide context (disease outbreak, confinements instaured in many countries) is a stressful factor for many people. It can have consequences on mental health : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. Patients with mental disorders are especially vulnerable. On march 17th, the french government ordonned a national confinement to slow the progression of the COVID-19 outbreak, for 15 days at first then renewed several times. This situation has led to a reorganization of care as requested on March 22nd, 2020 in the recommendations applicable to the organization of care in psychiatric services : priority to telephone contacts and teleconsultation by multiplying contacts and assessments. By the time the reorganization of care became operational, the most vulnerable patients may have experienced a decompensation of their disease. It is important to know if the COVID-19 outbreak combined with the confinement increased the number of unvoluntary commitment the month after the announce of the confinement. This could help us understand which patients are more vulnerable is this context, and improve our organization (ambulatory and hospitalization care) if this situation occurs again.
Description: Number of hospitalized patients From March 12th to April 09th
Measure: Number of hospitalized patients Time: 1 monthsDescription: Primary psychiatric diagnostic From March 12th to April 09th
Measure: Cause of hospitalization Time: 1 monthsDescription: Patients without psychiatric antecedent (number) From March 12th to April 09th
Measure: Lengh of hospitalization Time: 1 monthsDescription: Presence of absence of history of treatment interruption leading to the hospitalization From March 12th to April 09th
Measure: Treatment interruption Time: 1 monthsDescription: Number of hospitalized patients living alone (opposed to those living with family) From March 12th to April 09th
Measure: Number of hospitalized patients living alone Time: 1 monthsDescription: Number of patients using drugs From March 12th to April 09th
Measure: Use of drugs Time: 1 monthsIn times of pandemics, social distancing, isolation and quarantine exacerbate depression and anxiety as confined people are detached from their loved ones, deprived of personal liberties, and devoid of purpose owing to altered routine and livelihood (1,2). Those with pre-existing mental health problems or illnesses (MHPIs) might suffer from limiting interpersonal interactions that are central to their self-management, as well as reduced access to helpful but "non-essential" (often cancelled) psychiatric services (3). In response to this situation, this feasibility study of a trial consists of offering a transitional measure of online peer support for people suffering from (a) psychotic disorders or (b) anxiety and mood disorders, and to determine an effect size to this Peer Support Workers-delivered intervention in terms of both personal-civic recovery and clinical recovery (4). Peer Support Workers (PSWs) are persons with first-hand lived experience of MHPIs, and who are further along in their own recovery journey. As recommended by recovery-oriented best practices guidelines (5,6), upon training and certification they can provide supportive services when hired to fill such a paid specialty position directly in, or in conjunction with, current psychiatric services. Indeed, recovery focuses on how individuals can have more active control over their lives (agency). It is characterized by a search for the person's strengths and capacities, satisfying and meaningful social roles, and mobilizing formal and informal support systems. Peer support has thus become one predominant concept in the recovery paradigm and PSWs are specialized in peer support. Yet, not much is known about the efficacy of PSWs from a consumer's perspective of personal-civic recovery. The five principal research questions are whether this online intervention will have an impact in terms of (Q1) personal-civic recovery potential and (Q2) clinical recovery potential, (Q3) how these potentials can be impacted by the COVID-19 pandemic, (Q4) how the lived experience of people in recovery can be mobilized to cope with such a situation, and (Q5) how sex and gender considerations can be taken into account for the pairing of PSWs with service users, beyond considerations based solely on psychiatric diagnoses or specific MHPIs.
Description: Recovery Assesment Scale (RAS). This is a 24-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of recovery. Minimum score = 24 : maximum score = 120.
Measure: Assessment of patients' current status : recovery (personal recovery) Time: 14 weeksDescription: Participating patients will fill out the Citizenship Measure (CM). This is a 23-item questionnaire with 5-point Likert scales (1-2-3-4-5). Higher scores are positively correlated with higher levels of citizenship. Minimum score = 23 : maximum score = 115.
Measure: Assessment of patients' current status : citizenship (personal recovery) Time: 14 weeksDescription: Participating with 5-point Likert scales (0-1-2-3-4). Higher scores are positively correlated with higher levels of COVID-related levels of stress. Minimum score = 0 : maximum score = 144.
Measure: Assessment of patients' current status : COVID-19 Stress Scales Time: 14 weeksDescription: Participating patients will fill out the Anxiety State-Trait Anxiety Inventory Form Y6 (STAI-Y6). This is a 6-item questionnaire with 4-point Likert scales (1-2-3-4). Higher scores are positively correlated with higher levels of anxiety. Minimum score = 6 : maximum score = 24.
Measure: Assessment of patients' current status : anxiety (clinical recovery) Time: 14 weeksDescription: Participating patients will fill out the Depression Patient Health Questionnaire (PHQ-9). This is a 9-item questionnaire with 4-point Likert scales (0-1-2-3). Higher scores are positively correlated with higher levels of depression. Minimum score = 0 : maximum score = 27.
Measure: Assessment of patients' current status : depression (clinical recovery) Time: 14 weeksDescription: Participating patients will fill out the Alcohol Use Disorders Identification Test (AUDIT-10). This is a 10-item questionnaire with 5-point Likert scales (0-1-2-3-4). Higher scores are positively correlated with higher levels of alcohol dependence. Minimum score = 0 : maximum score = 40.
Measure: Assessment of patients' current status : alcohol dependence (clinical recovery) Time: 14 weeksDescription: Participating patients will fill out the Drug Abuse Screening Test (DAST-10). This is a 10-item questionnaire with noyes answers (0-1). Higher scores are positively correlated with higher levels of drog dependence. Minimum score = 0 : maximum score = 10.
Measure: Assessment of patients' current status : drug dependence (clinical recovery) Time: 14 weeksDescription: Psychosis Screening Questionnaire (PSQ 12 items) with no-unsure-yes answers (1-2-3). Higher scores are positively correlated with higher levels of psychosis. Minimum score = 12 : maximum score = 36.
Measure: Assessment of patients' current status : psychosis (clinical recovery) Time: 14 weeksDescription: Participating patients will fill out the World Health Organization Disability Assessment Schedule (WHODAS 2.0). This is a 12-item questionnaire with 5-point Likert scales (0-1-2-3-4). Lower scores are positively correlated with higher levels of social functioning. Minimum score = 0 : maximum score = 48.
Measure: Assessment of patients' current status : social functioning (clinical recovery) Time: 14 weeksAs a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation/parkinson treatment possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time. How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care?
Description: Quantitative online questionnaire Survey using UniPark
Measure: Interest in digital interventions (attitudes, behavioral intentions, behavioral experiences) Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)Description: Quantitative online questionnaire Survey using UniPark
Measure: Usability and effectiveness of digital interventions Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)Description: Quantitative online questionnaire Survey using UniPark
Measure: Stressors and barriers due to Covid-19 Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)Primary objective is to evaluate the feasibility of delivering an online early Eye Movement Desensitisation Reprocessing (EMDR) Recent Traumatic Events Protocol (R-TEP) to patients who have survived Covid-19 related critical illness, within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating the effectiveness of EMDR R-TEP in reducing psychological symptoms, for adult survivors of intensive care.
Description: Feasibility will be determined by the following measures: Able to recruit >30% of eligible patients approached Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention. Protocol adherence Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility. Outcome measures completed in 75% or more of trial participants
Measure: Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints Time: 12 monthsDescription: The PTSD Checklist-Civilian Version (PCL-C) is a validated, standardised self-reporting questionnaire for PTSD comprising of 17 items that correspond to key PTSD symptoms
Measure: Post-Traumatic stress disorder Time: 6 months post-hospital dischargeDescription: Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-reported measure with 7-items relating to symptoms of anxiety and 7-items relating to depression
Measure: Anxiety and depression Time: 6 monthsDescription: Montreal Cognitive Assessment (MoCA) is a validated tool, used to detect cogntive impairment
Measure: Cognitive function Time: 6 months post-hospital dischargeDescription: EQ5D -5L comprises five quality-of-life dimensions; mobility, self-care, usual activities, pain/discomfort andanxiety/depression.
Measure: Health Related Quality of Life Time: 6 months post-hospital dischargeDescription: WHODAS 2.0 is a generic assessment tool that produces standarised disability levels and profiles
Measure: Health and disability Time: 6 months post-hospital dischargeDescription: Wrist worn physical activity monitoring
Measure: Physical activity Time: 6 months post-hospital dischargeDescription: Patient generated subjective global assessment
Measure: Nutritional status Time: 6 months post-hospital dischargeIn the context of a viral outbreak and of widespread quarantine measures, a significant increase in psychological disorders, such as stress or fear behaviours, had previously been observed. This distress has been described on adults, but no data have been collected yet for paediatric populations. After a traumatic event, children and adolescents may present several clinical consequences, the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior problems. The aim of this study is to present the methodology of "CoCo 20" : is to assess the impact of the pandemic of coronavirus disease 2019 (Covid-19) and of seclusion measures on mental health and on the development of psychological disorders in children in the short to medium term
Description: measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments :
Measure: diagnosis of possible psychological and psychiatric difficulties at baseline Time: at baseline Day 0Description: measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments
Measure: follow up of psychological and psychiatric difficulties at V2 Time: at one month after baselineDescription: measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments
Measure: follow up of psychological and psychiatric difficulties at V3 Time: at one week after the end of the containmentDescription: measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments
Measure: follow up of psychological and psychiatric difficulties at V4 Time: at one month after the end of the containmentDescription: measure by Post-Traumatic Stress Disorder (PTSD) scale: The frequency and intensity of PTSD symptoms will be assessed using the Young Child PTSD Checklist (YCP) for children aged 3 months to 6 years and 11 months; or the Child PTSD checklist (CPC) for children aged 7 years to 17 years and 11 months ; or with the Post-Traumatic Stress Disorder ( PTSD) checklist 5 (PCL 5 ) for adults
Measure: impact of traumatic history prior to confinement Time: at one week after baseline and at one month after the end of the containmentDescription: measure by Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS): This is a semi-directed interview for children over the age of 7. It is done by interviewing the parent and the child. The interview covers both current issues.
Measure: impact of other previous psychiatric disorders Time: at one month after baseline and at one month after the end of the containmentDescription: measure by Parenting stress index-short form (PSI-SF) that measures the extent of parental stress, as well as stress in the relationship between parent and child, and parents' difficulties in the day-to-day management of children.
Measure: parental reaction Time: at one week after baseline and at one week after the end of the containmentThe aim of the proposed project is to provide a comprehensive assessment of the mental health impact of the ongoing COVID-19 outbreak in Spain. A prospective cohort study of three groups will be conducted: (1) COVID-19 cases or close contacts recently isolated or quarantined; (2) healthcare workers; (3) adult general population. Recruitment through epidemiologic surveillance services, hospitals, primary care centers in 6 Spanish Autonomous Communities (groups 1 & 2) and a random sample of individuals using telephone numbers as the sampling frames(group 3). Web-based surveys or telephone interviews at baseline and 6-month follow-up assess: current living and employment status; COVID-19 infection status; mental health (post-traumatic stress, panic, depression, anxiety, alcohol and substance use, suicidality; services use); psychological functioning; general health status and quality of life. Specific modules focus on isolation or quarantine (group 1) and care for COVID-19 patients (group 2). Short bi-weekly brief follow-up surveys among groups 1 & 2 will provide additional assessment of main outcomes in the two months following baseline assessment.
Description: It will be assessed with the 4-item version of the PTSD checklist for DSM-5 (PCL-5), which evaluates the presence and severity of 4 DSM-5 Criteria symptoms of PTSD over the past month (0 = not at all to 4 = extremely) and has been shown to generate diagnoses that closely parallel those of the full PCL-5 (AUC>0.9), making it well-suited for screening. The Spanish version is available.
Measure: Post-traumatic stress disorder Time: 6 monthsDescription: It will be evaluated with the Patient Health Questionnaire 8-item version (PHQ-8) with a 2-week recall period. Items have four response categories on frequency of the symptom that can be summed up to obtain a severity score, with cut-points of 5, 10, and 15 representing mild, moderate, and severe levels of depression, respectively, showing good diagnostic accuracy for depressive disorder (AUC>0.90) and high reliability (>0.8).
Measure: Depression Time: 6 monthsDescription: It will be screened with the seven-item Generalized Anxiety Disorder scale (GAD-7). Cut-points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety, respectively, with AUC>0.8 for the detection of anxiety. The Spanish versions of the PHQ and GAD-7 have been developed (https://www.phqscreeners.com).
Measure: Generalized Anxiety Disorder Time: 6 monthsDescription: It will be evaluated with a modified version of the Columbia Suicide Severity Rating Scale, including passive suicidal ideation ("wish you were dead or would go to sleep and never wake up"), active suicidal ideation ("have thoughts of killing yourself"), suicide plans ("think about how you might kill yourself [e.g., taking pills, shooting yourself] or work out a plan of how to kill yourself"), and suicide attempt ("make a suicide attempt [i.e., purposefully hurt yourself with at least some intent to die]).It has been translated into Spanish showing good discrimination ability for suicidal behavior.
Measure: Suicidal thoughts and behaviors Time: 6 monthsDescription: It will be evaluated with the CAGE questionnaire, that consists of 4 items focusing on Cutting down, Annoyance by criticism, Guilty feeling, and Eye-openers and have proved useful in helping to make a diagnosis of alcoholism.Item responses on the CAGE questions are scored 0 for "no" and 1 for "yes" answers, with a higher score being an indication of alcohol problems. A total score of two or greater is considered clinically significant. The questionnaire has been adapted into Spanish.
Measure: Alcohol and drug use problems Time: 6 monthsDescription: It will be assessed with item taken and adapted from the CIDI Screening Scales("Panic or anxiety attacks are sudden, strong feelings of fear or anxiety that reach their peak within a few minutes and are usually accompanied by physical reactions like racing heart, sweating, shortness of breath, feeling faint, or feeling sick to your stomach. People who have panic attacks sometimes feel like they might lose control, go crazy, or suddenly die. With this definition in mind, about how many panic attacks did you have since the onset of COVID-19 outbreak?")
Measure: Panic attacks Time: 6 monthsDescription: It will be assessed with the 5-level version of the EQ-5D-5L, for which a Spanish version is available showing good validity.
Measure: Health-related Quality of Life Time: 6 monthsDescription: It will be evaluated with a single item assessing general health, ''In general, how would you rate your health'' with response options of ''excellent, very good, good, fair, or poor''), which has shown to have a strong association with negative health outcomes, including mortality [10.1111/j.1525-1497.2005.0291.x]. The Spanish version of the item has provided similar results .
Measure: Overall Perceived Health Time: 6 monthsDescription: It will be assessed using an adapted version of the Sheehan Disability Scale that assessed impairment separately in each of four role domains: home management/chores, work roles, close personal relationships, and social life.
Measure: Role limitation Time: 6 monthsThe study consists in a pragmatic superiority randomized controlled trial comparing different strategies of psychotherapy for professionals and students from essential services with high levels of emotional distress during the COVID-19 pandemic in Brazil. Therapeutic strategies to be evaluated are Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation, as an active control. Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.
Description: Proportion of participants with a 50% reduction in T-scores at 1-month in the scales Patient-Reported Outcomes Measurement Information System (PROMIS) of Depression, Anxiety and Anger that were scored above 70 at baseline.
Measure: Symptom Reduction at 1-month Time: 1-monthDescription: Proportion of participants with a 50% reduction in T-scores at 3 and 6-months follow-up in the scales Patient-Reported Outcomes Measurement Information System (PROMIS) of Depression, Anxiety and Anger that were scored above 70 at baseline measured
Measure: Symptom Reduction at 3 and 6-months follow-up Time: 3 and 6-monthDescription: Remission levels (proportion of patients with T-score of 50 or below) in distress scales (PROMIS of Depression, Anxiety and Anger)
Measure: Remission Levels in distress scales Time: 1, 3 and 6-monthsDescription: Service satisfaction measured by the net-promoter score at the end of the treatment (proportion of promoters - scores of 9 or 10)
Measure: Service Satisfaction Time: 1-monthDescription: Mean score change in quality of life scale (PROMIS General Life Satisfaction Scale or GLSS)
Measure: Improvement in Quality of Life Time: 1, 3 and 6-monthsSome COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory function, quality of life, and psychological status in severe COVID-19 patients.
Description: Distance walked during 6-minutes (meters)
Measure: Six minute walk distance Time: Change from baseline measure at hospital discharge to week 6 and 12Description: The SGRQ scores from 0 (no impairment of quality of life by respiratory diseases/symptoms) to 100 (highest impairment of quality of life by respiratory diseases/symptoms)
Measure: Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ) Time: Change from baseline measure at hospital discharge to week 6 and 12Description: The Patient Health Questionnaire-9 (PHQ-9) consists of nine items covering the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. A greater score means worse depressive symptoms.
Measure: Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9) Time: Change from baseline measure at hospital discharge to week 6 and 12Description: The Generalized Anxiety Disorder-7 (GAD-7) consists of seven items covering the DSM-IV criteria for GAD scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 21. A higher score means worse anxiety symptoms.
Measure: Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire Time: Change from baseline measure at hospital discharge to week 6 and 12Description: The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better health-related quality of life
Measure: Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire Time: Change from baseline measure at hospital discharge to week 6 and 12Description: EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually.
Measure: Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire Time: Change from baseline measure at hospital discharge to week 6 and 12Description: Measured in milliliters by dynamic spirometry
Measure: Forced expiratory volume in the first second Time: Change from baseline measure at hospital discharge to week 6 and 12Description: Measured in milliliters by dynamic spirometry
Measure: Forced Vital Capacity Time: Change from baseline measure at hospital discharge to week 6 and 12Description: IES-R consists of 21 items covering the DSM-IV criteria for PTSD. Score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress).
Measure: Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire. Time: Change from baseline measure at hospital discharge to week 6 and 12Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports