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Name (Synonyms) | Correlation | |
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drug529 | Burnout Wiki | 0.20 |
drug411 | Bereavement Virtual Support Group Wiki | 0.20 |
drug385 | Background questionnaire Wiki | 0.20 |
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drug3223 | Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later Wiki | 0.20 |
drug3244 | T89 capsule Wiki | 0.20 |
drug1943 | Medical Music Wiki | 0.20 |
drug1213 | Experiences in Close Relationship Scale questionnaire (ECR-S) Wiki | 0.20 |
drug1235 | Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki | 0.20 |
drug1661 | Interpersonal Psychotherapy Wiki | 0.20 |
drug837 | Confinement and Communication During the COVID-19 Pandemic Wiki | 0.20 |
drug683 | Cannabis, Medical Wiki | 0.20 |
drug1968 | Mental Health questionnaire Wiki | 0.20 |
drug3351 | Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28 Wiki | 0.20 |
drug635 | COVID-surgRES questionaire Wiki | 0.20 |
drug2378 | Patient Health Questionnaire (PHQ-9) Wiki | 0.20 |
drug3683 | autologous adipose-derived stem cells Wiki | 0.20 |
drug3749 | cries 13 questionnaire Wiki | 0.20 |
drug2357 | PTSD Wiki | 0.20 |
drug400 | Basic Body Awareness Therapy Wiki | 0.20 |
drug2916 | SHG Wiki | 0.20 |
drug3619 | Written Summary of Rounds Wiki | 0.20 |
drug2644 | Psychological treatment Wiki | 0.20 |
drug1601 | Impact of COVID-19 questionnaire Wiki | 0.20 |
drug2559 | Post Traumatic Stress Disorder questionnaire (PTSD-8) Wiki | 0.20 |
drug2612 | Prolonged Exposure Therapy Wiki | 0.20 |
drug1584 | Imaging by thoracic scanner Wiki | 0.20 |
drug3463 | Two doses of placebo at the schedule of day 0, 28(high-dose group) Wiki | 0.20 |
drug3355 | Three doses of placebo at the schedule of day 0, 14, 28(high-dose group) Wiki | 0.20 |
drug2101 | Narrative Writing Wiki | 0.20 |
drug3464 | Two doses of placebo at the schedule of day 0, 28(middle-dose group) Wiki | 0.20 |
drug2020 | MinnRAP Peer Support Program Wiki | 0.20 |
drug2424 | Phone call Wiki | 0.20 |
drug1273 | Feeling Good Digital App Wiki | 0.20 |
drug3450 | Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 Wiki | 0.20 |
drug445 | Biological: COVID-19 convalescent plasma Wiki | 0.20 |
drug439 | Biological sampling Wiki | 0.20 |
drug1346 | Generalized Anxiety Disorder-7 (GAD 7) Wiki | 0.20 |
drug3456 | Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 Wiki | 0.20 |
drug3979 | questionnaire filling Wiki | 0.20 |
drug1101 | EMDR Wiki | 0.20 |
drug3098 | Spartan Cube Point-of Care Covid-19 test Wiki | 0.20 |
drug3494 | Unified Protocol for COVID-19 Parenting Stress (UP-COVID) Wiki | 0.20 |
drug1927 | Maslach Burnout Inventory (MBI) Wiki | 0.20 |
drug681 | Cannabidiol Wiki | 0.14 |
drug3051 | Simple cognitive task intervention Wiki | 0.14 |
drug310 | Attention Placebo Wiki | 0.14 |
drug376 | BNT162b1 Wiki | 0.12 |
drug377 | BNT162b2 Wiki | 0.10 |
drug453 | Biospecimen Collection Wiki | 0.10 |
drug2760 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki | 0.09 |
drug2687 | Questionnaire Administration Wiki | 0.06 |
drug2685 | Questionnaire Wiki | 0.04 |
drug2448 | Placebo Wiki | 0.02 |
Name (Synonyms) | Correlation | |
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D013313 | Stress Disorders, Post-Traumatic NIH | 0.82 |
D004194 | Disease NIH | 0.20 |
D000070627 | Chronic Traumatic Encephalopathy NIH | 0.20 |
Name (Synonyms) | Correlation | |
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D005879 | Tourette Syndrome NIH | 0.20 |
D003424 | Crohn Disease NIH | 0.20 |
D005356 | Fibromyalgia NIH | 0.14 |
D000070642 | Brain Injuries, Traumatic NIH | 0.14 |
D015775 | Fractures, Stress NIH | 0.14 |
D000690 | Amyotrophic Lateral Sclerosis NIH | 0.14 |
D012640 | Seizures NIH | 0.14 |
D016472 | Motor Neuron Disease NIH | 0.14 |
D000068376 | Compassion Fatigue NIH | 0.14 |
D000067073 | Psychological Trauma NIH | 0.14 |
D006526 | Hepatitis C NIH | 0.14 |
D001714 | Bipolar Disorder NIH | 0.14 |
D001008 | Anxiety Disorders NIH | 0.13 |
D000755 | Anemia, Sickle Cell NIH | 0.10 |
D001930 | Brain Injuries, NIH | 0.09 |
D001927 | Brain Diseases NIH | 0.09 |
D003866 | Depressive Disorder NIH | 0.08 |
D010300 | Parkinsonian NIH | 0.08 |
D009103 | Multiple Sclerosis NIH | 0.08 |
D015212 | Inflammatory Bowel Diseases NIH | 0.08 |
D003863 | Depression, NIH | 0.07 |
D012598 | Scoliosi NIH | 0.07 |
D000066553 | Problem Behavior NIH | 0.07 |
D059350 | Chronic Pain NIH | 0.07 |
D002055 | Burnout, Professional NIH | 0.07 |
D016638 | Critical Illness NIH | 0.05 |
D000077062 | Burnout, Psychological NIH | 0.05 |
D001523 | Mental Disorders NIH | 0.04 |
D014947 | Wounds and Injuries NIH | 0.04 |
D013315 | Stress, Psychological NIH | 0.04 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
D018352 | Coronavirus Infections NIH | 0.02 |
D013577 | Syndrome NIH | 0.02 |
D003141 | Communicable Diseases NIH | 0.01 |
D011014 | Pneumonia NIH | 0.01 |
D007239 | Infection NIH | 0.01 |
Name (Synonyms) | Correlation | |
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HP:0100280 | Crohn's disease HPO | 0.20 |
HP:0006802 | Abnormal anterior horn cell morphology HPO | 0.14 |
HP:0100754 | Mania HPO | 0.14 |
Name (Synonyms) | Correlation | |
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HP:0007354 | Amyotrophic lateral sclerosis HPO | 0.14 |
HP:0001250 | Seizure HPO | 0.12 |
HP:0001298 | Encephalopathy HPO | 0.09 |
HP:0000716 | Depressivity HPO | 0.08 |
HP:0002037 | Inflammation of the large intestine HPO | 0.08 |
HP:0012532 | Chronic pain HPO | 0.07 |
HP:0000708 | Behavioral abnormality HPO | 0.07 |
HP:0002090 | Pneumonia HPO | 0.01 |
Navigate: Correlations HPO
There are 25 clinical trials
This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.
Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).
Measure: Prevention of COVID-19 Time: Five yearsDescription: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).
Measure: Treatment of COVID-19 Time: Five yearsDescription: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.
Measure: Treatment of Symptoms Time: Five yearsDescription: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.
Measure: Cannabis Impact on Quality of Life Time: Five yearsDescription: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.
Measure: Cannabis Route and Dosing Time: Five yearsDescription: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.
Measure: Monitoring Adverse Events Time: Five yearsCoronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus. The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients. PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).
Description: Proportion of Family members with IES-R> 22 PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge of corresponding patient. It si a scale ranging from 0 to 88. Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411
Measure: PTSD Family members sup 22 Time: 90 daysDescription: Among Family members PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)
Measure: PTSD Family members Time: 90 daysDescription: Among Patients PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)
Measure: PTSD Patients Time: 90 daysDescription: Among healthcare providers PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised)
Measure: PTSD healthcare providers Time: 2 months after official end of the Covid-19 peakDescription: Among Family members Symptoms of anxiety and depression using the HADS scale
Measure: HADS Family members Time: 90 daysDescription: Among Patients Symptoms of anxiety and depression using the HADS scale
Measure: HADS Patients Time: 90 daysDescription: Among Patients Mental and physical health-related quality of life as assessed by the SF36
Measure: SF36 Patients Time: 90 daysDescription: Among Family members Questionnaire describing their experience of the patient's ICU hospitalization
Measure: Questionnaire Family members Time: 90 daysDescription: Among Patients Questionnaire describing their experience of the patient's ICU hospitalization
Measure: Questionnaire Patients Time: 90 daysDescription: Among healthcare providers Questionnaire describing their experience of the patient's ICU hospitalization
Measure: Questionnaire healthcare providers Time: 2 months after official end of the Covid-19 peakDescription: Among healthSymptoms of burnout on MBI scale as assessed by the Maslash Burnout Inventorycare providers
Measure: MBI healthcare providers Time: 2 months after official end of the Covid-19 peakDescription: Job Strain as assessed by the Karasec instrument
Measure: Karasec instrument healthcare providers Time: 2 months after official end of the Covid-19 peakThe aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers during the strict social distancing government-initiated non-pharmacological interventions (NPI's) related to the COVID-19 pandemic. The study also aims to investigate predictors of trauma-symptoms.
Description: PCL-5 is 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.
Measure: PTSD Checklist for DSM-5 (PCL-5) Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in NorwayDescription: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27.
Measure: Patient Health Questionnaire 9 (PHQ-9) Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in NorwayDescription: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21.
Measure: The Generalized Anxiety Disorder 7 (GAD-7) Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in Norway]Description: Symptoms of health anxiety was measured with two items from the validated Health Anxiety Inventory (HAI), one item measuring specific fear of being infected by coronavirus, and an item measuring fear of dying by the coronavirus. All items used a Likert scale from 0-3, and the new total score of health anxiety had a range from 0-12.
Measure: Health anxiety Time: All data was collected between March 31st 2020 and April 7th 2020, a period where the NPIs (nonpharmacological interventions) against the COVID-19 pandemic were identical and constant in NorwayThe aim of this randomized controlled clinical trial is to assess the effectiveness of Basic Body Awareness Therapy online in patients' survivors of Covid-19, health workers and women suffering from gender based violence regarding post-traumatic stress disorder in comparison with treatment as usual. The study will be multicentric in base Hospital Igualada and University of Lleida. The participants will be survivors of Covid-19 that had been inpatient in intensive care and health workers in first line with pandemia as doctors, nurse, physiotherapist, etc. More else, a new context emerge regarding gender based violence during the lockdown time. Outcomes variables will be measured regarding post-traumatic stress disorder, anxiety, depression, pain, quality of life and sleep. Fifty-four patients will be randomly assigned to a control group that will follow treatment as usual. The intervention group that will be received the same treatment adding Basic Body Awareness Therapy. The intervention will last 3 months twice a week at online format. At first month the intervention consisted of 12 movements and 15 min for sharing reflections about experiences. During the subsequent sessions, the treatment will be in group of 8 participants using the same methodology online. If the conditions of pandemia allow, the group will be presential in the health center at last month. Data analysis will performed using ANOVA of variables intragroup with repeated measurements. The analyses of the effects between groups will be performed throught ANOVA intergroup.
Description: The DTS is a 17-item self-report measure that assesses the 17 DSM-IV symptoms of PTSD. Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). Respondents are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they have had with each symptom. 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). It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters
Measure: Change in Davidson Trauma Scale (DTS) Time: Baseline, 1 month , 3 months and 6 months follow upDescription: BDI consisting of 21 items with a score range from 0 to 63, with a higher score indicating a greater degree of depression.
Measure: Change in Beck Depression Inventory (BDI) Time: Baseline, 1 month , 3 months and 6 months follow upDescription: Stai with statements scoring from 1 to 4; the whole score is from 0 to 60, with higher scores indicating a greater degree of anxiety
Measure: Change in State-Trait Anxiety Inventory (STAI) Time: Baseline, 1 month , 3 months and 6 months follow upDescription: It measured quality of life, a generic tool whose scores range from 0 to 100; higher scores denote better quality of life. It contains 36 items grouped into eight subscales: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health.
Measure: Change in Short Form 36 (SF36) Time: Baseline, 1 month , 3 months and 6 months follow upDescription: VAS measures subjective characteristics that cannot be directly measured. The pain is measured from 0 to 10, with 0 representing "no pain" and 10 "unbearable pain".
Measure: Change in Visual Analogue Scale (VAS) Time: Baseline, 1 month , 3 months and 6 months follow upDescription: Is an instrument used to measure the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5" or greater indicates a "poor" sleeper. Although there are several questions that request the evaluation of the client's bedmate or roommate, these are not scored, nor reflected in the attached instrument.
Measure: Change in Pittsburgh Sleep Quality Index (PSQI) Time: Baseline, 1 month , 3 months and 6 months follow upThe Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.
Description: Professional Quality of Life Questionnaire (proQOL): min score of 10; max score of 50; higher scores mean worse outcome
Measure: Change in professional quality of life Time: Before peer support program, through study completion (an average of 7 months)Description: Stress Risk & Resilience Self-Index: min score 0; max score of 12; higher scores mean worse outcome
Measure: Change in mental health symptoms and resilience markers Time: Before peer support program, through study completion (an average of 7 months)The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing post-traumatic stress disorder, especially in cancer patients who feel more at risk of contracting the virus, and fear developing serious symptoms. The study's primary objective is to measure the presence of a potential post-traumatic stress disorder in cancer patients, and to assess the associated factors. The secondary objectives are to measure patients' anxiety, as well as their perception of both the management of their cancer care, and their fear of a cancer recurrence. It is a prospective, multi-centric study using self-assessing survey offered to cancer patients currently under ongoing care or treatment. The surveys will be sent by post at the beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000 patients will be contacted, over a period of 3 months, in order to receive 1600 responses, and 640 responses 6 months later. Researching the factors associated with the appearance of post-traumatic stress could lead to better screening of patient disorders in highly anxiety-provoking crisis situations. As a result, it would lead to an improvement of their care, healthcare organization, and their follow-up in the case of a new epidemic or any other stressful event of this magnitude. Furthermore, promoting the patient's expression capabilities favors their implication in their care, and facilitates the development of health democracy.
Description: The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale
Measure: Factors associated with post-traumatic stress disorder Time: at inclusion and 6 months laterDescription: The measure of anxiety, measured by the State-Trait Anxiety Questionnaire
Measure: Measure of the patient's anxiety Time: at inclusion and 6 months laterThe World Health Organization (WHO) declared in early 2020 the emergence of a new highly contagious SARS-CoV-2 coronavirus responsible for a global public health emergency. In France, the first cases of contamination have been reported since the end of January 2020, and the first death in mid-February 2020. Then, data published by Public Healh France reported an increasing and rapidly exponential number of contaminations. First cases have been identified on a cluster mode, then rapidly spreading in some French departments and regions, indicating rapid kinetics of virus spread. Given the magnitude of the situation both French territory and neighboring European territories (mainly Italy), the government mobilized the entire health system to critically manage this epidemic. This exceptional and unprecedented pandemic deeply impacted the health structures, disrupting healthcare organizations. All caregivers, including all student nurses, actively participated in the mobilization and strengthening of care teams. The health crisis exposed the population of caregivers to potentially traumatic events which can have major repercussions on their health state. The description and identification of the risk factors of the occurrence of post traumatic stress disorders in student nurses during the health crisis would allow to provide avenues for improving training devices and to facilitate health workers access to specific psychological care particularly dedicated to the student nurses population needs.
Description: Proportion of students with IES-R> 22 PTSD-related symptoms. Impact of Event Scale - Revised (IES-R) is a 22-item self-report measure that assesses subjective distress caused by traumatic events. ... The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.
Measure: Prevalence of PTSD-related symptoms assessed by the IES-R Time: 1 month after the end of the French epidemic Covid-19 peakDescription: IES-R> 22 PTSD-related symptoms in the total population of students nurses( 3 years training)
Measure: PTSD-related symptoms assessed by the IES-R in the total population of students nurses Time: 1 month after the end of the French epidemic Covid-19 peakDescription: IES-R> 22 PTSD-related symptoms in each population of students nurses of first-, second-, and third-year.
Measure: PTSD-related symptoms assessed by the IES-R according to student's years of school Time: 1 month after the end of the French epidemic Covid-19 peakQuarantine related to the Covid-19 pandemic has begun on the 03/17/2020 in France. Quarantine has already be linked to pejorative effects on mental health. In this study, we aim to evaluated PTSD symptoms of patients already followed by a psychiatrist during quarantine, one month and 3 months after inclusion. It will be also evaluate various psychiatric symptoms.
Description: PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.
Measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine Time: at inclusionDescription: PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.
Measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine Time: at 1 month after inclusionDescription: PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) (6). The PCL-5 is an instrument that consists of 20 items rated from 0 to 4 to obtain a score from 0 to 80. A score greater than or equal to 31-33 defines the presence of posttraumatic stress disorder.
Measure: Number of patients with post-traumatic stress disorder (PTSD) defined by a total score on PCL-5 ≥ 31 at the time of quarantine Time: at 3 months after inclusionDescription: This self-questionnaire is intended to measure subjective post-traumatic stress after a traumatic situation (within 7 days) but is not a diagnostic tool. It includes 22 items rated from 0 (not at all) to 4 (extremely). There are 3 sub-scales: an avoidance subscale (items 5, 7, 8, 11, 12, 13, 17, 22): the sum of the scores on each of these items ranges from 0 to 35; Memory intrusion subscale (items 1, 2, 3, 6, 9, 14, 16 and 20): the sum of the scores on each of these items ranges from 0 to 40; a Hyperarousal/High Neurovegetative Activation subscale (items 4, 10, 15, 18, 19 and 21): the sum of the scores on each of these items ranges from 0 to 35. A total score of at least 22 suggests the presence of significant symptoms of acute stress. A score of 36 and above suggests the presence of post-traumatic stress disorder.
Measure: IES-R (Impact of Events Scale Revised) Time: at inclusion, then at 1 month and 3 months after inclusionDescription: closed-ended question: Yes /No
Measure: Presence of suicidal ideation during the past month at the different times of the study Time: at inclusion, then at 1 month and 3 months after inclusionDescription: questionnaire with a 28 item scaled and assesses somatic symptoms, anxiety and insomnia, social dysfunction and severe depression that ranges from a 'better/healthier than normal' option, through a 'same as usual' and a 'worse/more than usual' to a 'much worse/more than usual' option. The exact wording will depend upon the particular nature of the item.
Measure: Total score at GHQ-28 (General Health Questionnaire) Time: at inclusion, then at 1 month and 3 months after inclusionDescription: 13 questions rated from 0 to 3 to obtain a score from 0 to 39 The higher the score, the greater the symptomatology: 0 to 3 (no depression), 4 to 7 (mild depression), 8 to 15 (depression of moderate to moderate intensity), greater than 16 (severe depression).
Measure: Total score at BDI (Beck Depression Inventory) Time: at inclusion, then at 1 month and 3 months after inclusionDescription: 7 questions rated from 0 to 4 to obtain a score from 0 to 28 The higher the score, the greater the symptomatology: 0 to 7 (no insomnia), 8 to 14 (mild insomnia), 15 to 21 (moderate insomnia), 22 to 28 (severe insomnia).
Measure: Total score at ISI (Insomnia Severity Index) Time: at inclusion, then at 1 month and 3 months after inclusionDescription: It's a Likert scale from 14 to 70. The higher the score, the higher the level of well-being.
Measure: Total score Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Time: at inclusion, then at 1 month and 3 months after inclusionDescription: Socio-demographic factors, linked to medical history and the experience of the epidemic.
Measure: Socio-demographic factors significantly associated with all scores Time: at inclusion, then at 1 month and 3 months after inclusionThe purpose of the questionnaire is to find risk factors for the development of post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy.
Description: PTSD consists in job burnout, including emotional exhaustion, depersonalization, and personal accomplishment.
Measure: Number of patients with diagnosis of PTSD. Time: Through study completion, an average of 1 monthsThe purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers cope with these stressors.
Description: The Overall Anxiety Severity and Impairment Scale (OASIS) is a 5 self-reported questionnaire evaluating the severity and functional impairment due to anxiety. The total score ranges from 0 (no anxiety) to 20 (severe anxiety).
Measure: Measure of Anxiety as assessed by the OASIS Time: week 6 and week 12Description: Overall Depression Severity and Impairment Scale (ODSIS) is a 5-item measure assessing the frequency and intensity of depressive symptoms. The total score ranges from 0-20 with the higher score indicating increased depression.
Measure: Measure of Depression as assessed by the ODSIS Time: week 6 and week 12Description: PTSD Checklist (PCL-5) is a 20-item measure of PTSD symptoms in adults. Total score ranges from 0 to 80 with the higher score indicating higher PTSD symptoms.
Measure: Measure of PTSD as assessed by the PCL-5 Time: week 6 and week 12Description: The Egna Minnen Betraffande Uppfostran - Short Form (S-EMBU) is a 9-item measure that assesses parents' perception of their overprotection/control. Total scores ranging from 9 (low overcontrol) to 36 (high overcontrol).
Measure: Measure of Parenting Overprotection/Overcontrol as assessed by the S-EMBU Time: week 6 and week 12Description: The Egna Minnen Betraffande Uppfostran - Short Form is a 7-item measure that assesses parents' perception of their rejection. Total score ranging from 7 (low rejection) to 28 (high rejection).
Measure: Measure of Parenting Rejection as assessed by the S-EMBU Time: week 6 and week 12Description: The Egna Minnen Betraffande Uppfostran - Short Form is a 6-item measure that assesses parents' perception of their emotional warmth. Total scores ranging from 6 (low warmth) to 24 (high warmth).
Measure: Measure of Parenting Emotional Warmth as assessed by the S-EMBU Time: week 6 and week 12Description: The Family Accommodation Scale - Anxiety (FASA) is a 13-item measure that assesses parent's accommodation of their child's anxiety related behaviors. Total scores range from 0 (low accommodation) to 52 (high accommodation).
Measure: Measure of Parent Accommodation for Child Anxiety as assessed by the FASA Time: week 6 and week 12The aim of this study is to investigate the levels of trauma and mental symptoms (i.e., depression and anxiety) among health workers and public service providers 3 months after (T2) the strict social distancing government initiated non-pharmacological interventions (NPIs) related to the COVID-19 pandemic (T1), in a period of lifted distancing protocols. The study also aims to investigate predictors of trauma-symptoms, by analyzing how predictors measured during the COVID-19 pandemic are associated with change in PTSD symptoms from T1 to T2.
Description: PCL-5 is a 20-item self-administered questionnaire which assesses the full domain of the DSM-5 PTSD diagnosis. The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely."The PCL-5 has four subscales, corresponding to each of the symptom clusters in the DSM-5.
Measure: PTSD Checklist for DSM-5 (PCL-5) Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaireDescription: The Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) is used to measure symptoms of depression in accordance with the diagnostic criteria for major depressive disorder. The questionnaire consists of nine items where each is scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27.
Measure: Patient Health Questionnaire 9 (PHQ-9) Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaireDescription: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is a questionnaire consisting of seven items measuring symptoms of anxiety and worry. The items are scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21.
Measure: Generalized Anxiety Disorder 7 (GAD-7) Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaireDescription: WEMWBS short version consist of 7 items
Measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) Time: Data is set to be collected starting from 22th of June. The data collection period will last no longer than three weeks depending on the response to the questionnaireStudies have shown that admission to hospital during a coronavirus epidemic is associated with increased levels of anxiety, depression and panic disorder. During the SARS-CoV-2 pandemic in North London the Royal Free Hospital admitted over 500 patients with Covid-19. As part of the standard of care, these patients are screened at 8 weeks post discharge for signs of anxiety and depression. The Feeling Good app is a NHS approved digital application which utilises applied relaxation, mindfulness based cognitive therapy and positive visualisation through audio tracks for the treatment of anxiety and depression. This is a naturalistic cohort study aimed to track the post illness psychological symptoms of those who have been admitted with Covid-19 to the Royal Free hospital up to 5-7 months after discharge. The study population is those who are exhibiting anxiety or depressive symptoms as measure by the PHQ-2 or TSQ questionnaires. All those with symptoms will be offered free access to a NHS approved app for anxiety and depression, and followed up for 3 months after recruitment to track changes to their symptoms.
Description: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.
Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale Time: Day 14Description: The Patient Health Questionnaire (PHQ-9) is a screening tool for the identification of depressive disorders, which has been validated for use in primary care. Each of the nine items in the questionnaire is based on the DSM diagnostic criteria for clinical depression. The PHQ-9 is scored out of 27 according to severity, where score of 5-9 indicates mild depression, 10-14 moderate, 15-19 moderately severe, and 20 or above severe depression.
Measure: Depression as measured by the patient health questionnaire 9 (PHQ-9) Time: 14 days and week 12Description: The Trauma screening questionnaire (TSQ) is a 10 point scale used to identify symptoms of post traumatic stress disorder (PTSD), with a score between 0 and 10, with a score of 6 or higher scored as positive.
Measure: Trauma as measured by Trauma screening questionnaire (TSQ) Time: 12 weeksDescription: Generalised anxiety disorder score (GAD-7) scale. Score 0-21, with a higher score associated with greater anxiety symptoms. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. GAD-7 score at baseline will be controlled for.
Measure: Anxiety as measured by generalised anxiety disorder score (GAD-7) scale Time: Week 12Description: Risk factors for psychological distress from admission with Covid-19 will be collected, these will include, age, gender, ethnicity, length of hospital stay, oxygen requirement, co-morbidites, years of education, smoking status, occupation.
Measure: Risk associated with distress Time: Baseline analysisDescription: Framework analysis. Qualitative feedback of patient experience. Semi structured interviews of a subset of patients will be performed to gain further insight into the patient experience. These will be analysed using a framework thematic analysis, to identify themes which will then be used to code the text.
Measure: Qualitative analysis Time: BaselinePrimary 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 dischargeThis research study is designed to investigate the effects of a remotely delivered simple cognitive task (a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) on intrusive memories ("flashbacks") and other symptoms after a traumatic event(s). Hospital staff who experienced a work-related traumatic event(s) during the COVID-19 pandemic will be randomly allocated to either the simple cognitive task intervention or control. Randomization to assigned intervention occurs on Day 1, after completion of baseline measures (note: baseline measures are not used in randomization process). Baseline measures include questionnaires on Day 1 and an intrusive memory diary during the previous week (Week -1). Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories, less severe related clinical symptoms, and will show higher functioning (e.g. at work) than those who are not. This will inform the future development of a simple technique to prevent distressing psychological symptoms after a traumatic event(s). Implementation and training aspects regarding remote recruitment and intervention delivery in a hospital context will also be explored. Participants use e.g. their smartphone for part of the intervention in the study.
Description: Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
Measure: Number of intrusive memories of traumatic event(s) Time: Week 5Description: Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily (morning, afternoon, evening and night) for 7 days.
Measure: Number of intrusive memories of traumatic event(s) Time: Week -1 and Week 1Description: A single item measuring the frequency of intrusive/unwanted memories of the traumatic event(s) in the previous week on a 7-point scale (from "never" to "many times a day", with a follow-up question to specify the number if necessary) that will be used as a convergent measure for medical hospital staff who may face time constraints completing the diary.
Measure: Intrusion questionnaire - frequency item Time: Baseline (Day 1), Week 1 and 5 and 1, 3, and 6 month follow-upDescription: 5 self-rated items measuring the characteristics of intrusive/unwanted memories in the previous week. The level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the intrusive/unwanted memories of the traumatic event(s) are measured on a 101-point scale (from 0 to 100). Higher scores indicate more intrusive/unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and a greater number of different triggers.
Measure: Intrusion questionnaire - characteristics Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-upDescription: Self-report measure that assesses subjective distress after a traumatic event (with reference to study event[s]) in the last week. Here we include the intrusion subscale (8 items) and the avoidance subscale (8 items). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscale scores are calculated for the Intrusion or Avoidance items summed (ranging from 0 to 32 each). Higher scores indicate worse outcome.
Measure: Impact of Event Scale - Revised (IES-R): Degree of subjective distress of post-trauma intrusion and avoidance symptoms Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-upDescription: The PCL-5 short version is an 8-item self-report measure that assesses current symptoms of post-traumatic stress disorder in the last month [Baseline (Day 1), 1, 3, and 6 month follow-up] and in the last week (One week). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The PCL-5 short version yields a total symptom severity score which ranges from 0 to 32. Subscale symptom severity scores for DSM-5 symptom cluster B - intrusion symptoms (items 1-2), cluster C - avoidance (items 3-4), cluster D - negative alterations in cognitions and mood (items 5-6), and cluster E - alterations in arousal and reactivity (items 7-8). Higher scores indicate worse severity.
Measure: Posttraumatic Stress Disorder Checklist 5 (PCL-5) short version Time: Baseline (Day 1), One week and 1, 3, and 6 month follow-upDescription: 2 self-rated items measuring the level of distress and vividness associated with the intrusions (11 point scales from 0 to 10) rated within the diary at baseline (Day 1), week 1 and week 5. High scores indicate higher level of distress/vividness.
Measure: Characteristics of intrusive trauma memories Time: Baseline (Day 1), Week 1 and week 5Description: Two items measuring the level of concentration disruption associated with the intrusions (11 point scale from 0 to 10) and the duration of disruption (< 1 min, 1-5 min, 5-10 min, 10-30 min, 30-60 min, > 60 min). High scores indicate higher level of concentration disruption and longer duration of disruption.
Measure: Self-rated concentration disruption associated with intrusive memories Time: Baseline (Day 1), Week 1 and Week 5, 1, 3, and 6 months follow-upDescription: 3 bespoke items including a question on impact on work-related functioning, and one on daily functioning in other areas associated with the intrusions and a question on perceived social support after the traumatic event. All items are rated on an 11-point scale (from 0 "none"; 5 "some"; 10 "extreme/much"). Higher scores indicate higher level of functional impairment/perceived social support.
Measure: Self-rated functioning and social support ratings Time: Baseline (Day 1), One week, 1, 3, and 6 month follow upDescription: 6 self-report items (11-point scale from 0 to 100) measuring appraisals of intrusions on two subscales: psychological problems (items 1-3) and negative self-evaluations (items 4-6). Items for each subscale will be summed. Possible subscale scores range from 0 - 300, with higher values indicative of worse appraisals.
Measure: Appraisals of intrusive memories Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: Two self rated items: Item 1 measures the extent of being troubled by poor sleep (with reference to study event) on a 5 point scale (from not at all to very much), and item 2 measures the number of nights in the week with sleep problems on a 5 point scale (from 0-1 to 5-7 nights). Each 5-point scale is reverse scored (4 - 0) then summed. Possible total scores range from 0 - 8, with higher values indicative of better sleep.
Measure: Self-rated sleep ratings Time: Baseline (Day 1), one week and 1, 3, and 6 month follow-upDescription: A single item measuring perceived health status on a seven-point scale (from very good to very bad). The scale is reverse scored. High scores indicate good outcomes.
Measure: Self Rated Health (SRH) rating Time: Baseline (Day 1), one week, and 1, 3, and 6 month follow-upDescription: 3 free text response field questions (e.g. which type of health care do you work with right now?) at Day 1 and two free text response field questions on whether the work situation changed and if yes, how, at one week, 1, 3, and 6 month follow-up.
Measure: Questions related to work situation Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: 2 bespoke items measuring the total number and the number of full work days on sick leave because of reason for seeking health care. Higher numbers indicate more sick leave.
Measure: Sick leave Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: 3 items measuring the frequency of feeling stressed, pressured, tensed at work during the previous week on a 5-point scale (from "never" to "several times per day"). Item scores are summed. Higher scores indicate higher levels of stress. Further, a single item measuring difficulties to let go of work-related thoughts during leisure time (from "very rarely or never" to "very often or always") and a single question about whether the above mentioned difficulties are because of intrusive memories with a yes/no response.
Measure: Stress and Energy Questionnaire (SEQ) - Stress subscale Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: 9 self-report items (4-point scale from 1 "not at all" to 4 "all the time") measuring symptoms of burnout on three subscales: Exhaustion (items 1-3), disengagement (items 4-6) and inattentiveness (items 7-9). Subscale scores will be the mean of all items per subscale, the total burnout score will be the mean of all items (ranging from 1-4) with higher scores indicative of higher levels of exhaustion/disengagement/inattentiveness/burnout.
Measure: Scale of Work Engagement and Burnout (SWEBO) - Burnout subscale Time: Baseline (Day 1) and 6 month follow-upDescription: 5 self-report items measuring moral stress at work on a 4-point scale ranging from 1 ("Strongly agree") to 4 ("Strongly disagree"). All items are summed. Potential scores range from 5-20, with higher scores indicative of lower levels of moral stress.
Measure: Moral stress at work Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: A free text response field measuring the occurrence of any health problems since the last contact.
Measure: Adverse events Time: One week and 1, 3, and 6 month follow-upDescription: A free text response field asking to imagine a future self identity. Then a free text response field to describe a mental image of this identity, 2 items measuring vividness (from 1 "not vivid at all" to 10 "very vivid") and positivity (from 1 "very negative" to 10 "very positive") of that image on a 10-point scale and 1 item measuring the perspective of viewing that mental image ("through own eyes" or "as if seeing oneself") before and after the traumatic event(s). Higher scores on rating scales indicate higher levels of vividness/positivity.
Measure: Future self questionnaire - shortened version Time: 3 month follow-upDescription: 8 self-report items (5-point scale from 1 to 5) measuring time perspective on three subscales: past perspective (items 3, 5, 7), present perspective (items 1, 8) and future perspective (items 2, 4, 6). Item scores for each subscale will be summed. Higher values indicate higher levels of past/present/future time perspective.
Measure: Time perspective questionnaire Time: Baseline (Day 1), One week, 1, 3, and 6 month follow-upDescription: 2 free text response field questions (e.g. Are there any specific factors you think have made it easier for you to handle the COVID-19 situation and its consequences?) at Day 1.
Measure: Coping mechanisms Time: Baseline (Day 1)Description: 5 item questionnaire (11-point scale from 0 to 10) that rates to what degree the participant finds the intervention credible. High scores indicate greater credibility.
Measure: Credibility/expectancy questionnaire Time: Day 1Description: A bespoke manipulation check item measuring self-rated distress during the intervention/control procedure (11-point scale from 0 to 10) at 3 times during the intervention process. Higher scores indicate higher level of distress.
Measure: Subjective Units of Distress (SUDS) Time: Day 1Description: 8 bespoke items including questions about study participation e.g. how acceptable was it to do the task? Rated on 11-point scale from 0 (not at all) to 10 (extremely), higher scores indicate higher acceptability; and questions about what has happened since the study with a yes/no response e.g. have you had any psychological or medical treatment since you did the task; and items with a free text response field e.g. do you have any other comments.
Measure: Feedback questionnaire about participation Time: 1 month follow-upThe investigators thought that the confinement measure took in France could induce an increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during this period indeed the restricted visit and the limited interaction with ICU team are documented risk factors for PTSD in this population. The investigators designed an intervention in order to prevent the effect of the confinement measures on PTSD in relatives named OLAF. In this research the investigators aimed to study the impact on this intervention on PTSD.
Description: To demonstrate the benefits of a comprehensive family approach (OLAF) on the incidence of PTSD observed in 2 close referents of a patient, 6 months after leaving the intensive care unit, in the context of confinement linked to the SARS pandemic- CoV2.
Measure: incidence of PTSD observed 6 months after patient's discharge from the intensive care unit Time: Month 6Description: The incidence of PTSD 6 months after patient's death in the intensive care unit
Measure: incidence of PTSD observed 6 months after patient's death in the intensive care unit Time: Month 6Description: The incidence of PTSD 3 months after the death or discharge from the intensive care unit
Measure: PTSD incidence at month 3 Time: Month 3Description: The incidence of PTSD 12 months after the death or discharge from the intensive care unit
Measure: PTSD incidence at month 12 Time: Month 12Description: The incidence of symptoms of anxiety and / or depression 3 months after death or discharge from the intensive care unit
Measure: Symptoms incidence at month 3 Time: Month 3Description: The incidence of symptoms of anxiety and / or depression 6 months after death or discharge from the intensive care unit
Measure: Symptoms incidence at month 6 Time: Month 6Description: The incidence of symptoms of anxiety and / or depression 12 months after death or discharge from the intensive care unit
Measure: Symptoms incidence at month 12 Time: Month 12Description: The incidence of persistent complicated grief 3 months after death in intensive care
Measure: incidence of persistent complicated grief at month 3 Time: Month 3Description: The incidence of persistent complicated grief 6 months after death in intensive care
Measure: incidence of persistent complicated grief at month 6 Time: Month 6Description: The incidence of persistent complicated grief 12 months after death in intensive care
Measure: incidence of persistent complicated grief at month 12 Time: Month 12Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high mortality, estimated to be about 1.7% of all infected in the US, though in those who develop acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient isolation has become the standard of care, with many hospitals eliminating visitors of any type, and particularly eliminating visitation to patients infected with COVID-19. These necessary, but restrictive, measures add stress to the ICU and particularly to the family members who are not only left with fear, but also many unanswered questions. In contrast to the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU and recent data from this study team which suggests engaging families in end-of-life situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members, family members are now unable to say good-bye and unable to provide support to their loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that these restrictive visiting regulations will increase rates of Post-intensive care syndrome- family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate for factors that either exacerbate these symptoms or protect from them.
Description: Using Impact of Events Scale-Revised-6 , family members will be screened for symptoms of PTSD. Scale returns scores of 0-24, with higher scores indicating more likely to have symptoms of PTSD
Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) Time: 90-120 days after admission of patient to the ICUDescription: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of anxiety. The HADS anxiety scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of anxiety
Measure: Symptoms of Anxiety Time: 90-120 days after admission of patient to the ICUDescription: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of Depression. The HADS depression scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of depression
Measure: Symptoms of Depression Time: 90-120 days after admission of patient to the ICUDescription: Using preselected questions from the Family Satisfaction in the ICU-27 questionnaire, we will survey families to evaluate their satisfaction with communication and decision making. Higher scores will indicate more satisfication
Measure: Family Satisfaction with Communication and Decision Making Time: 90-120 days after admission of patient to the ICUThe aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).
Description: test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry. Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety
Measure: Results of the Generalized Anxiety Disorder (GAD-7) Time: 5 MinutesDescription: Welfare effect (mental health positively or negatively affected by COVID-19; why?) Scored between 7-42. These are treated as continuous variables.
Measure: Results of the Mental Health questionnaire Time: 5 minutesDescription: assess depression during the pandemic Scored between 0-27: Cut offs: 0-4 = None 5-9 = Mild depression 10-14 = Moderate depression 15-19 = Moderately severe depression 20-27 = Severe depression
Measure: Results of the Patient Health Questionnaire (PHQ-9) Time: 5 minutesDescription: Assessing the trauma of subjects during the pandemic Scored between 7-42. These are treated as continuous variables.
Measure: Results of the Post Traumatic Stress Disorder (PTSD-8) Time: 5 minutesDescription: Measuring social ties and attachment of subjects Scored between 7-42. These are treated as continuous variables.
Measure: Results of the Experiences in Close Relationship Scale questionnaire (ECR-S) Time: 5 minutesFamilies of patients in Intensive Care Units (ICUs) are at increased risk for developing psychological symptoms that can last for months after the patient is discharged. These symptoms can have significant impact on both the patient and family member's quality of life. The investigators have found that families of patients admitted to the Rush University Medical Center ICU during to the COVID-19 pandemic were more likely to develop clinically significant psychological symptoms than families of patients admitted prior to the COVID-19 pandemic. The investigators suspect that this finding is due in part to the hospital-wide no visitation policy that altered our standard communication practices and may have prevented families from being active participants in the patient's medical care. The goals of this project are 1) to determine the prevalence of psychological disorders among families of COVID-19 patients after ICU discharge 2) to determine the characteristics of ICU care that were associated with the development of psychological disorders among family members and 3) to pilot a program in which families with psychological disorders after ICU discharge receive therapy from mental health professionals.
Description: Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) initial Time: Measured once upon enrollmentDescription: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.
Measure: Symptoms of Anxiety and Depression initial Time: Measured once upon enrollmentDescription: Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.
Measure: Surrogate Satisfaction with the Patient's ICU Care: Time: Measured once upon enrollmentDescription: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.
Measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) final Time: Measured after behavioral intervention (6-12 weeks after enrollment)Description: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.
Measure: Symptoms of Anxiety and Depression final Time: Measured after behavioral intervention (6-12 weeks after enrollment)Description: Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms
Measure: Interview initial Time: Measured once upon enrollmentDescription: Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms
Measure: Interview final Time: Measured after behavioral intervention (6-12 weeks after enrollment)The objective of this work is to monitor the level of stress and overload of a group of front-line health workers (physicians, nurses and physiotherapists) who will participate in the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its Emergency Unit (HCRP), for four weeks, and evaluate the cannabidiol - CBD's effectiveness in reducing stress for those who wish to use it.
Description: To assess the emotional exhaustion dimension of the burnout syndrome, based on nine items, scored from 0 ("never") to 6 ("every day")
Measure: aMBI-HSS: Abbreviated Maslach Burnout Inventory - Human Services Survey Time: Through study completion, over time during the study period (day 0-28)Description: brief measure for assessing generalized anxiety disorder
Measure: Brief measure for assessing generalized anxiety disorder: The GAD-7 Time: Through study completion, over time during the study period (day 0-28)Description: Evaluate depressive symptoms o
Measure: PHQ-9: Patient´s Health Questionnaire-9 Time: Through study completion, over time during the study period (day 0-28)Description: Laboratory parameters, including the change in proinflammatory cytokine concentrations
Measure: Change in proinflammatory cytokine concentration Time: Through study completion, over time during the study period (day 0-28)Description: Occurrence of side effects
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Time: Through study completion, over time during the study period (day 0-28)Description: It is a self-report measure widely used to assess PTSD symptoms, according to the DSM-5 criteria. The reduced version of this instrument will be used (8 items)
Measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Time: Through study completion, over time during the study period (day 0-28)Based on the experience of previous pandemics, countries reacted by applying different upgrade strategies to prevent or delay the widespread of the disease. Therefore, measures such as border closure, school closure, restrict social gathering (even shutdown of workplaces), limit population movements, and confinement meaning quarantines at the scale of cities or regions. In public hospitals, several measures have been decided to concentrate the power of care on potential wave of admissions of patients with severe forms of Covid-19. In this purpose, the number of available beds in Intensive Care Units (ICU) has been increased by two-fold and scheduled non-emergency surgical procedure have been cancelled. That means: 1. For the most severe patients, new personals (physician such as anesthesiologists, nurses of other units) have been transferred in ICUs. 2. For the less severe patients, personals of non-busy units have been transferred in busier ones. All these measures lead to major daily-life change sets that could be stressful. In the general population, it has been well documented that quarantine or confinement or isolation could lead to the occurrence of Post-Traumatic Stress Disorder (PTSD) syndrome in about 30% overall population. Importantly, high depressive symptoms have been reported in 9% of hospital staff. Numerous symptoms have been reported after quarantine or isolation such as emotional disturbance, depression, stress, low mood, irritability, insomnia, and post-traumatic stress symptoms. In hospital setting, few studies have been performed for assessing the psychological impact of quarantine and isolation. However, two studies reported a high prevalence of burn-out syndrome (BOS) in ICU physician and PTSD syndrome and depression in ICU nurses. As the consequences of all the measures decided and applied during Covid-19 pandemic could be important on caregivers, the present study primarily aims at assessing the prevalence of PTSD syndrome in a large population of caregivers implied or not in Intensive Care Units. The secondary objective were 1) to assess the prevalence of severe depression and anxiety and BOS 2) to isolate potential factors associated with PTSD, severe depression, anxiety or BOS.
Description: PCL - 5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5)
Measure: Post-Traumatic Stress Disorder Time: 3-6 month after the Covid-19 outbreakDescription: HADS scale (Hospital Anxiety and Depression Scale)
Measure: anxiety and depression Time: 3-6 month after the Covid-19 outbreakDescription: Score MBI (Burn out syndrome)
Measure: Burn out Time: 3-6 month after the Covid-19 outbreakThe epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . To this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. Emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the AP-HP and Hospitals level. The objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. Hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (PTSD), and depressive episodes as defined in the DSM-5. This study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. The results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. The main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.
Description: Rate of respondents with a PTSD defined as score higher or equal to 32 for PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) at, at least, one of the three measures (inclusion, M3 or M6)
Measure: Prevalence of PTSD among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months or 6 months). Time: 6 monthsDescription: Rate of respondents with an Anxiety Disorder defined as score higher or equal to 8 for the HAD-A subscale (Hospital Anxiety and Depression - Anxiety subscale) independently at each measure (inclusion, M3 and M6)
Measure: Prevalence of Anxiety Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, 3 months and 6 months). Time: baseline, 3 months and 6 monthsDescription: Rate of respondents with a Depressive Disorder defined as score higher or equal to 8 for the HAD-D subscale (Hospital Anxiety and Depression - Depression subscale) independently at each measure (inclusion, M3 and M6)
Measure: Prevalence of Depressive Disorder among APHP staff during the COVID-19 epidemic and at a distance (inclusion, M3 and M6). Time: baseline, 3 months and 6 monthsHospital health workers involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion , unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making. Preliminary data suggests that frontline and lay professionals suffer from different types of psychological distress. These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as Eye Movement Desensitization and Reprocessing (EMDR, desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19. This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).
Description: This study is investigating three different conditions (PTSD, Depression and Burnout) each assessed with its own primary endpoint. Thus, the trial will have three primary endpoints. Change over a 6 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.
Measure: Efficacy on symptoms of Post-Traumatic Stress Disorder Time: From inclusion to 6 months after inclusionDescription: Change over a 6 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.
Measure: Efficacy on symptoms of Burnout Time: From inclusion to 6 months after inclusionDescription: Change over a 6 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.
Measure: Efficacy on symptoms of Depression Time: From inclusion to 6 months after inclusionDescription: Change over a 3 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.
Measure: Short-term efficacy on symptoms of PTSD Time: From inclusion to 3 months after inclusionDescription: Change over a 3 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.
Measure: Short-term efficacy on symptoms of Burnout Time: From inclusion to 3 months after inclusionDescription: Change over a 3 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.
Measure: Short-term efficacy on symptoms of Depression Time: From inclusion to 3 months after inclusionDescription: Change over a 12 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5) for the participants who will be enrolled in the trial at M0 of the cohort. The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.
Measure: Long-term efficacy on symptoms of PTSD Time: From inclusion to 12 months after inclusionDescription: Change over a 12 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL) for the participants who will be enrolled in the trial at M0 of the cohort. The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.
Measure: Long-term efficacy on symptoms of Burnout Time: From inclusion to 12 months after inclusionDescription: Change over a 12 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9) for the participants who will be enrolled in the trial at M0 of the cohort. The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.
Measure: Long-term efficacy on symptoms of Depression Time: From inclusion to 12 months after inclusionDescription: Change over a 6 months period in anxiety measured by the Generalized Anxiety Disorder-7 questionnaire (GAD-7). The GAD-7 score is on a scale from 0 to 21. The higher the score, the higher the level of anxiety symptoms are.
Measure: Efficacy on symptoms of Anxiety Time: From inclusion to 6 months after inclusionDescription: Change over a 12 months period in anxiety measured by the Generalized Anxiety Disorder-7 questionnaire (GAD-7) for the participants who will be enrolled in the trial at M0 of the cohort. The GAD-7 score is on a scale from 0 to 21. The higher the score, the higher the level of anxiety symptoms are.
Measure: Long-term efficacy on symptoms of Anxiety Time: From inclusion to 12 months after inclusionDescription: Number of suicide attempts over a 6-month period from baseline
Measure: Efficacy on suicide attempts Time: From inclusion to 6 months after inclusionDescription: Changes in the level of suicidal ideation over a 6 months period from baseline measured by Visual Analog Scale (VAS). The VAS is on a scale from 0 to 10. The higher the VAS score, the higher suicidal ideation level is.
Measure: Efficacy on suicidal ideation Time: From inclusion to 6 months after inclusionDescription: Changes in the level of suicidal ideation over a 12 months period from baseline measured by Visual Analog Scale (VAS) for the participants who are enrolled in the trial at M0 of the cohort. The VAS is on a scale from 0 to 10. The higher the VAS score, the higher suicidal ideation level is.
Measure: Long-term efficacy on suicidal ideation Time: From inclusion to 12 months after inclusionDescription: Change in the impact of health on functioning (Role Emotional (RE) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 6 months period from baseline. The RE score is on a scale from 0 to 100. The higher the score, the better Role Emotional is.
Measure: Efficacy on the impact of health on functioning: Role Emotional Time: From inclusion to 6 months after inclusionDescription: Change in the impact of health on functioning (Role Emotional (RE) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 12 months period from baseline for the participants who are enrolled in the trial at M0 of the cohort. The RE score is on a scale from 0 to 100. The higher the score, the better Role Emotional is.
Measure: Long-term efficacy on the impact of health on functioning: Role Emotional Time: From inclusion to 12 months after inclusionDescription: Change in the impact of health on functioning (Role Physical (RP) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 6 months period from baseline. The RP score is on a scale from 0 to 100. The higher the score, the better Role Physical is.
Measure: Efficacy on the impact of health on functioning: Role Physical Time: From inclusion to 6 months after inclusionDescription: Change in the impact of health on functioning (Role Physical (RP) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 12 months period from baseline for the participants who are enrolled in the trial at M0 of the cohort. The RP score is on a scale from 0 to 100. The higher the score, the better Role Physical is.
Measure: Long-term efficacy on the impact of health on functioning: Role Physical Time: From inclusion to 12 months after inclusionDescription: Evolution of substance use over 6 months
Measure: Substance use Time: From inclusion to 6 months after inclusionDescription: Evolution of substance use over 12 months for the participants who are enrolled in the trial at M0 of the cohort
Measure: Long-term substance use Time: From inclusion to 12 months after inclusionDescription: Evolution of medication use over 6 months
Measure: Medication use Time: From inclusion to 6 months after inclusionDescription: Evolution of medication use over 12 months for the participants who are enrolled in the trial at M0 of the cohort
Measure: Long-term medication use Time: From inclusion to 12 months after inclusionDescription: Number of consultations of health professionals within the period of follow-up (general practitioner, psychiatrist, psychotherapist, psychologist, professionals who are practicing alternative medicines); Occurrence of EMDR therapy within the control group; Number of visits at the emergency unit of a hospital; Number of nights spent in hospital as a patient (short-term); Number of nights spent in rehabilitation facilities as a patient.
Measure: Health care utilization Time: From inclusion to 6 months after inclusionDescription: Number of consultations of health professionals within the period of follow-up (general practitioner, psychiatrist, psychotherapist, psychologist, professionals who are practicing alternative medicines); Occurrence of EMDR therapy within the control group; Number of visits at the emergency unit of a hospital; Number of nights spent in hospital as a patient (short-term); Number of nights spent in rehabilitation facilities as a patient. For the participants who are enrolled in the trial at M0 of the cohort
Measure: Long-term health care utilization Time: From inclusion to 12 months after inclusionDescription: Proportion of those who will be offered EMDR and will actually receive EMDR
Measure: Acceptability of EMDR in the EMDR group Time: From inclusion to 12 months after inclusionDescription: Number of sessions attended over the total planned number
Measure: Compliance in the EMDR group Time: From inclusion to 12 months after inclusionIntroduction: Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by the World Health Organization, which can have negative consequences for pregnant women and their newborns. It is estimated that 1 in 5 women will develop a mental illness in the perinatal period. COVID-19 pandemic has been associated with anxiety and depression in the population. The current pandemic is a unique stressor with potentially wide-ranging consequences in the perinatal period, but little is known about the impact of COVID-19 on perinatal mental health. Thus, the objective of this study is to explore the experiences of pregnant and new mothers during the current pandemic, particularly its impact on perinatal mental health (including depression, anxiety, PTSD and psychological distress). Methods: The study design is a prospective observational study, with a baseline assessment and three follow-ups: one month; three months; and six months post baseline. This international study will be carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, United Kingdom) Chile and Brazil. The study population will comprise pregnant women and new mothers with an infant under six months of age, covering a broad range of women across the perinatal period. Ethics and dissemination: The study and handling of the data will follow all national required data protection standards. Each researcher (or team of researchers) involved will submit the project to their local ethical committee before starting the project. Results from the project will be disseminated in peer reviewed journals and international conferences.
Description: Number of depressive symptoms evaluated by Edinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30. Higher scores mean worse outcome
Measure: Depressive symptoms Time: June 2020- June 2021Description: Number of Post-Traumatic Stress Disorders (PTSD) symptoms evaluated by check list of DSM-5. HIgher number of symptoms mean worse outcomes
Measure: Posttraumatic Stress Disorder Time: June 2020- June 2021Description: Number of anxiety symptoms evaluated by General Anxiety Disorder questionnaire (GAD 7). Scores range from 0 to 21. Higher scores mean worse outcomes.
Measure: Anxiety symptoms Time: June 2020- June 2021The current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). In this study CRIES-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020
Description: Using a simple score (Child Revised Impact of Event Scale (CRIES-13)), determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020
Measure: Signs of post traumatic stress disorder Time: 1 monthIt is expected that large numbers of healthcare workers will experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers caring for COVID-19 patients. There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention. After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.
Description: Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Measure: Feasibility Indicator: Recruitment (Phase I) Time: BaselineDescription: Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.
Measure: Feasibility Indicator: Recruitment (Phase II) Time: Post-Phase I Assessment at week 2Description: Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Measure: Feasibility Indicator: Enrollment (Phase I) Time: BaselineDescription: Feasibility assessment will include enrollment defined as number of individuals beginning phase II.
Measure: Feasibility Indicator: Enrollment (Phase II) Time: Post-Phase I Assessment at approximately week 2Description: Feasibility assessment will include retention defined as the number of participants completing the full course of Phase I interventions.
Measure: Feasibility Indicator: Retention (Phase I) Time: Post-Phase I Assessment at approximately week 2Description: Feasibility assessment will include retention defined as the number of participants completing the full couse of Phase II interventions.
Measure: Feasibility Indicator: Retention (Phase II) Time: Post-Phase II Assessment at approximately week 7Description: Acceptability and treatment satisfaction will be rated with a Likert scale.
Measure: Acceptability Indicator: Satisfaction (Phase I) Time: Post-Phase I Assessment at approximately week 2Description: Acceptability and treatment satisfaction will be rated with a Likert scale.
Measure: Acceptability Indicator: Satisfaction (Phase II) Time: Post-Phase II Assessment at approximately week 7Description: Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Measure: Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Measure: Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety Higher scores indicate greater symptom severity.
Measure: Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: Scored between 0-21: Cut offs: 0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety Higher scores indicate greater symptom severity.
Measure: Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: 21-item self-report measure. Scored between 0-63. Higher scores indicate greater symptom severity.
Measure: Change in Depressive Symptoms measured by the Beck Depression Inventory-II (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: 21-item self-report measure. Scored between 0-63. Higher scores indicate greater symptom severity.
Measure: Change in Depressive Symptoms measured by the Beck Depression Inventory-II (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: 24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered "good". A score of greater than 5 refers to poor sleep quality.
Measure: Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: 24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered "good". A score of greater than 5 refers to poor sleep quality.
Measure: Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: 21 item self-report measure measuring moral distress (the emotional state that arises from a situation when an individual feels that the ethically correct action to take is different from what he/she is tasked with doing). Score range is 0-336. Higher scores indicate greater moral distress.
Measure: Change in score on the Moral Distress Scale (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: 21 item self-report measure measuring moral distress (the emotional state that arises from a situation when an individual feels that the ethically correct action to take is different from what he/she is tasked with doing). Score range is 0-336. Higher scores indicate greater moral distress.
Measure: Change in score on the Moral Distress Scale (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: 11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury.
Measure: Change in score on the Modified Moral Injury Events Scale (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: 11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury.
Measure: Change in score on the Modified Moral Injury Events Scale (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.
Measure: Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.
Measure: Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: 10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Measure: Change in score on the Sheehan Disability Scale (SDS) (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: 10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Measure: Change in score on the Sheehan Disability Scale (SDS) (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: The minimum score is 0 and the maximum score is 100. High score shows better result.
Measure: Change in score on the World Health Organization Quality of Life Scale - Brief (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: The minimum score is 0 and the maximum score is 100. High score shows better result.
Measure: Change in score on the World Health Organization Quality of Life Scale - Brief (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome.
Measure: Change in score on the Social Adjustment Scale (SAS) (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome.
Measure: Change in score on the Social Adjustment Scale (SAS) (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.
Measure: Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.
Measure: Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: 12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree), resulting in a total score in the range of 12-84. Higher scores indicate higher perceived social support by Friends and Family/Significant Others.
Measure: Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: 12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree), resulting in a total score in the range of 12-84. Higher scores indicate higher perceived social support by Friends and Family/Significant Others.
Measure: Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: 33-item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. The measure is rated between 1 (Totally disagree) to 7 (Totally agree). The score range is 33-231. Higher scores indicate greater symptom severity.
Measure: Change in score on the Posttraumatic Cognitions Inventory (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: 33-item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. The measure is rated between 1 (Totally disagree) to 7 (Totally agree). The score range is 33-231. Higher scores indicate greater symptom severity.
Measure: Change in score on the Posttraumatic Cognitions Inventory (Phase II) Time: Start of Phase II to approximately 5 weeksDescription: The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.
Measure: Change in score on the Difficulties in Emotion Regulation Scale (DERS) (Phase I) Time: Start of Phase I to approximately 2 weeksDescription: The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.
Measure: Change in score on the Difficulties in Emotion Regulation Scale (Phase II) Time: Start of Phase II to approximately 5 weeksAlphabetical 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