Covid 19 Clinical Trials

	Name (Synonyms)	Correlation
drug403	Brief cognitive intervention Wiki	0.29
drug418	C21 Wiki	0.20
drug447	COVID 19 diagnostic test by PCR Wiki	0.20
drug1992	Questionnary Wiki	0.20
drug1003	Goal Management Training (GMT) Wiki	0.20
drug2258	Simple cognitive task intervention Wiki	0.20
drug2393	Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later Wiki	0.20
drug419	C3+ Holter Monitor Wiki	0.20
drug935	Feeling Good Digital App Wiki	0.20
drug2273	Sleep Education Wiki	0.20
drug903	Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol Wiki	0.20
drug1438	Maslach Burnout Inventory (MBI) Wiki	0.20
drug2998	sertraline Wiki	0.20
drug426	CBT-OSA Wiki	0.20
drug1805	Phone call Wiki	0.20
drug617	Community based combination HIV prevention package Wiki	0.20
drug2817	faecal sample collector Wiki	0.20
drug1916	Prolonged Exposure (PE) Wiki	0.20
drug836	Elisa-test for IgM and IgG to SARS-CoV-2 Wiki	0.20
drug1534	Muse headband with Myndlift app Wiki	0.20
drug414	Burnout Wiki	0.20
drug1307	LDAEP Wiki	0.20
drug2448	Tele-delivered psychological intervention Wiki	0.20
drug1750	PTSD Wiki	0.20
drug1942	Psychological treatment Wiki	0.20
drug1173	IgM and IgG diagnostic kits to SARS-CoV-2 Wiki	0.20
drug243	Attention Placebo Wiki	0.20
drug1505	MinnRAP Peer Support Program Wiki	0.20
drug2050	Reconsolidation of Traumatic Memories (RTM) Wiki	0.20
drug323	Basic Body Awareness Therapy Wiki	0.20
drug1238	Intervention App Wiki	0.20
drug1909	Primary care professionals reports of potential patient safety incidents, non-COVID-19 related Wiki	0.20
drug1893	Prazosin Wiki	0.14
drug1788	Pentoxifylline Wiki	0.14
drug454	COVID-19 Convalescent Plasma Wiki	0.09
drug1822	Placebo Wiki	0.05

Correlated MeSH Terms (23)

	Name (Synonyms)	Correlation
D040921	Stress Disorders, Traumatic NIH	0.82
D004194	Disease NIH	0.33
D000068099	Trauma and Stressor Related Disorders NIH	0.29
D000067073	Psychological Trauma NIH	0.24
D015775	Fractures, Stress NIH	0.20
D001523	Mental Disorders NIH	0.17
D003072	Cognition Disorders NIH	0.14
D000068376	Compassion Fatigue NIH	0.14
D001008	Anxiety Disorders NIH	0.14
D020181	Sleep Apnea, Obstructive NIH	0.12
D012891	Sleep Apnea, NIH	0.10
D000070642	Brain Injuries, Traumatic NIH	0.09
D001930	Brain Injuries, NIH	0.08
D000066553	Problem Behavior NIH	0.08
D060825	Cognitive Dysfunction NIH	0.07
D016638	Critical Illness NIH	0.06
D003866	Depressive Disorder NIH	0.05
D014947	Wounds and Injuries NIH	0.05
D013315	Stress, Psychological NIH	0.04
D003863	Depression, NIH	0.03
D011014	Pneumonia NIH	0.02
D045169	Severe Acute Respiratory Syndrome NIH	0.02
D018352	Coronavirus Infections NIH	0.02

Correlated HPO Terms (6)

	Name (Synonyms)	Correlation
HP:0002870	Obstructive sleep apnea HPO	0.12
HP:0010535	Sleep apnea HPO	0.10
HP:0000708	Behavioral abnormality HPO	0.08
HP:0001268	Mental deterioration HPO	0.07
HP:0000716	Depressivity HPO	0.05
HP:0002090	Pneumonia HPO	0.02

There are 24 clinical trials

Clinical Trials

1 Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD

Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks for major health problems, including dementia, heart attack, and stroke. Obesity, a growing problem for Americans and Veterans alike, is the greatest risk factor for the development of OSA. Male gender and smoking, other OSA risk factors, are common in Veterans. Given the high comorbidity of these risk factors in Veterans, OSA presents a significant health burden to Veterans. The investigators' prior work provides evidence that OSA occurs in up to 69% of Vietnam-era Veterans with PTSD. OSA is easily treated; however, 15-30% of OSA patients are non-compliant with continuous positive airway pressure (CPAP), the standard OSA treatment. The proposed research aims to facilitate adherence to CPAP treatment by testing a novel cognitive-behavioral therapy intervention in Veterans with PTSD. If successful, it may represent an approach that could be applied to the rehabilitation of other chronic conditions with similar barriers to care.

NCT02641496 Obstructive Sleep Apnea PTSD Posttraumatic Stress Disorder Behavioral: CBT-OSA Behavioral: Sleep Education

MeSH:Sleep Apnea Syndromes Sleep Apnea, Obstructive Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

HPO:Obstructive sleep apnea Sleep apnea

Primary Outcomes

Description: The CPAP machine will measure the number of hours that the CPAP mask is on the participant's face and in use.

Measure: Time in hours of "mask-on" CPAP usage per night

Time: 1 year

Secondary Outcomes

Description: Effect of CBT on Self-reported Everyday Activities, Mood and Quality of Life. The investigators hypothesize that after initiating CPAP treatment, Veterans in the CBT-OSA group will report more improvement in the ease of performing everyday activities compared to that reported by those in the Education group.

Measure: Functional Outcomes of Sleep Questionnaire (FOSQ)

Time: 1 year

Description: Effect of CBT on Cognitive Outcomes. The CBT-OSA group will have better cognitive outcomes than the Education group over time. The California Verbal Learning Test-II, Delayed Recall Score is the cognitive outcome measure.

Measure: California Verbal Learning Test, Second Edition (CVLT-II)

Time: 1 year

Description: Effect of CBT on PTSD. The CBT-OSA group will have fewer PTSD symptoms than the Education group over time. The PTSD Checklist for DSM-5 (PCL-5) will be the PTSD outcome measure.

Measure: PTSD Checklist for DSM-5 (PCL-5)

Time: 1 year

2 Noradrenergic Biomarkers in PTSD: Precision Medicine & Mechanisms

Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. There are a variety of treatment options for PTSD, including psychotherapy (talk therapy) options, as well as medications, such as the drug prazosin. Each of the treatment options available is effective at significantly reducing the symptoms of PTSD in some, but not all, individuals with PTSD. However, investigators are not yet able to predict in advance who is likely to respond to which of the available treatments. Neither are the investigators able to explain what changes in the brain after exposure to a traumatic stressors, and why it results in persistent symptoms of PTSD for some people, but not for others. In this study, the investigators are testing two things: First, is testing whether two simple, easy tests of how an individual's blood pressure changes with standing and how an individual's eye reacts to a pulse of light may be able to predict whether that person is likely to respond to the medication prazosin for PTSD. Second, is testing whether those who have been exposed to a traumatic stress show differences in how their body regulates the response to the stress-signal noradrenaline.

NCT03539614 Posttraumatic Stress Disorder Drug: Prazosin Drug: Placebo

MeSH:Stress Disorders, Post-Traumatic

Primary Outcomes

Description: The PTSD Checklist for DSM 5 is a self-reported rating scale where an individual rates the severity of each symptom of PTSD on a likert scale. The ratings on individual items are summed to create a total score, which ranges from 0 to 80, with higher scores indicating more symptoms. The relationship between changes in participants' total PCL scores at different time points and prazosin exposure - and whether this relationship is moderated by baseline biomarker values - will be analyzed using a linear mixed effects model.

Measure: Change in total PTSD Checklist for DSM 5 (PCL5) score

Time: The PCL5 total score is assessed at baseline, during each stage of the study, and at the endpoint of the study. Thus, measurements will be scheduled to occur at the following time points, relative to the baseline visit: 0, 4, 8, 9-12, 16, and 20 weeks

3 RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)

Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base. The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. Blood draws will be obtained pre- and posttreatment to assess predictors of treatment response and epigenetic markers of change. The NIH Toolbox Neurocognitive Assessment, pre- and post-treatment, will assess impact on cognitive function. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More effective therapies for PTSD, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). The full study can now be conducted via video conferencing due to COVID-19.

NCT03827057 Posttraumatic Stress Disorder Traumatic Brain Injury Behavioral: Reconsolidation of Traumatic Memories (RTM) Behavioral: Prolonged Exposure (PE)

MeSH:Brain Injuries Brain Injuries, Traumatic Dis Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: the gold standard for PTSD diagnosis, a trained expert administrator scores PTSD symptom severity; range 0-80, higher score represents greater severity

Measure: Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5)

Time: week 10

Secondary Outcomes

Description: well-validated and widely used 9-item self-report measure of depression symptom severity, range 0-27, higher score represents greater severity

Measure: Change in Patient Health Questionnaire (PHQ-9) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 20-item screen for PTSD, in which each item is rated on a 5-point Likert scale, range 0-80, higher score represents greater severity

Measure: Change in PTSD Checklist for DSM5 (PCL5) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a clinically validated 9-item assessment of sleep quality and sleep disturbances; range 0 to 21, higher score represents greater severity

Measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 22-item self-report measure assessing functional status and post concussive symptoms, range 0-88, higher score represents greater severity

Measure: Change in Neurobehavioral Symptom Inventory (NSI) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Description: a reliable 100 item self-report inventory measuring overall quality of life in 8 dimensions; range 100 to 500, higher score represents greater severity

Measure: Change in World Health Organization Quality of Life Inventory (WHOQOL-100) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

Other Outcomes

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the single molecule array (SIMOA) technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma tumor necrosis factor-alpha level

Time: week 10, compared to baseline

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the SIMOA technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma interleukin-6 level

Time: week 10, compared to baseline

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the SIMOA technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma interleukin-10 level

Time: week 10, compared to baseline

Description: Normalized Summary Score for a battery of 7 tests to measure various aspects of cognition including memory, executive function, attention span; normed for age, with a score of 50 being average, scores greater than 50 demonstrate greater than average cognitive function, and scores lower than 50 indicating lower than average cognitive function

Measure: Change in NIH Toolbox Cognition Battery (NIH-TB) Neurocognitive Assessment Composite Score

Time: week 10, compared to baseline

4 An Electrophysiological Predictor of SSRI Response in Veterans With PTSD

This is a research study to examine the effectiveness of a brief screening method that may predict which people with posttraumatic stress disorder (PTSD) are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. Participants will be recruited over approximately 3.25 years, until at least 94 participants complete the 17 week study.

NCT04183205 Posttraumatic Stress Disorder Diagnostic Test: LDAEP Drug: Placebo Drug: sertraline

MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Description: The CAPS-5 is the "gold standard" clinical interview for assessing PTSD. This measure will be used to characterize the sample regarding PTSD diagnosis and as a measure of PTSD severity. Each of the 20 symptoms of PTSD included in DSM-5 is rated on a 5-point scale ranging from 0-4, with a 0 or 1 indicating that the symptom is absent or subthreshold and a score of 2-4 indicating that a symptom has reached the threshold to be included as a symptom and ranges in severity from moderate to extreme. The total range of the CAPS-5 is 0-80.

Measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Change

Time: Administered at screening session 1, and weeks 0, 2, 6, and 14

Secondary Outcomes

Description: The QIDS-SR will be used to measure the severity of depressive symptoms. The QIDS provides equivalent weightings (0-3) for each symptom item, gives clearly stated anchors that estimate the frequency and severity of symptoms, and includes all items required to diagnose a major depressive episode.

Measure: Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) Change

Time: Administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14

Description: The HAM-D is the most widely used clinician-administered scale for assessing severity of depression symptoms. The 6-item unidimensional core Melancholia subscale of the HAM-D will be used as the primary depression outcome variable.

Measure: Hamilton Depression Rating Scale (HAM-D) Change

Time: Administered at weeks 0, 2, 6 and 14

Description: DASS-21 is a 21-item measure that assesses the severity of a range of symptoms common to depression, anxiety, and stress. The total score can be used as a measure of general distress or depression, anxiety, and stress subscales can be scored separately.

Measure: Depression Anxiety Stress Scales (DASS-21) Change

Time: Administered at screening session 1, and weeks 0, 2, 6, and 14

Description: The PCL-5 is a 20-item measure that assesses DSM-5 symptoms of PTSD. Participants will rate how much they experienced each symptom on a 5-point Likert-type scale (0 = "not at all" to 4 = "extremely") during the past week (total range=0-80). The PCL-5 will be anchored to participants' worst traumatic event. In addition to the administration of these measures during the four assessment sessions, the PCL-5 will also be administered bi-weekly at each psychiatrist check-in visit.

Measure: PTSD Checklist for DSM-5 (PCL-5) Change

Time: Administered at screening session 1, and weeks 0, 2, 4, 6, 8, 10, 12, and 14

Description: The PANAS consists of two, 10-item mood scales that measure positive (e.g., 'enthusiastic') and negative (e.g., 'upset') affect separately.

Measure: The Positive and Negative Affect Schedule (PANAS) Change

Time: Administered at screening session 1, and weeks 0, 2, 6, and 14

Description: SCL-90-R measures the following nine primary psychiatric symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. The Global Severity Index (GSI) is the average rating given to all 90 items and provides a measure of general psychopathology.

Measure: Symptom Checklist (SCL-90-R) Change

Time: Administered at screening session 1, and weeks 0, 2, 6, and 14

5 "Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"

Coronavirus 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).

NCT04341519 Corona Virus Infection Post-traumatic Stress Disorder Behavioral: PTSD Behavioral: Burnout

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

HPO:Pneumonia

Primary Outcomes

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 days

Secondary Outcomes

Description: 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 days

Description: 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 days

Description: 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 peak

Description: Among Family members Symptoms of anxiety and depression using the HADS scale

Measure: HADS Family members

Time: 90 days

Description: Among Patients Symptoms of anxiety and depression using the HADS scale

Measure: HADS Patients

Time: 90 days

Description: Among Patients Mental and physical health-related quality of life as assessed by the SF36

Measure: SF36 Patients

Time: 90 days

Description: Among Family members Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire Family members

Time: 90 days

Description: Among Patients Questionnaire describing their experience of the patient's ICU hospitalization

Measure: Questionnaire Patients

Time: 90 days

Description: 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 peak

Description: 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 peak

Description: Job Strain as assessed by the Karasec instrument

Measure: Karasec instrument healthcare providers

Time: 2 months after official end of the Covid-19 peak

6 Anxiety and Work Resilience Among Tertiary University Hospital Workers During the COVID-19 Outbreak: An Online Survey

For limiting COVID-19 spreading, the World Health Organisation (WHO) recommended worldwide confinement on 2010. In France, unessential institutions were closed on March 14th and population confinement was decided on March 17th. Quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger COVID-19 outbreak highlighted a considerable proportion of health care workers (HCW) with depression, insomnia, anxiety and distress symptoms. In front line, facing the virus with the fear of contracting it and contaminate their closest. During previous outbreaks (H1N1, SARS), HCWs have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7). In France, Covid 19 outbeak led to increase ICU bed capacity with a full reorganization of the human resources. Some caregivers were reassigned to newly setup units admitting or not Covid-19 patients. In the same time, non-caregivers were also encouraged to work at home whenever possible. Thus, every hospital staff member's private and professional life could be altered by the Covid-19 outbreak. As all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our Tertiary University Hospital, (6300 employees). Secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed

NCT04358640 Critical Illness Sars-CoV2 SARS Pneumonia Coronavirus Infection Stress Disorders, Post-Traumatic

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Critical Illness Stress Disorders, Post-Traumatic

HPO:Pneumonia

Primary Outcomes

Description: Mesured by STAY Scale

Measure: Anxiety

Time: 15 to 45 days after the beginning of the outbreak

Secondary Outcomes

Description: Participant suffering of Insomnia

Measure: Insomnia

Time: 15 to 45 days after the beginning of the outbreak

Description: Participant suffering of catastrophism

Measure: Catastrophism

Time: 15 to 45 days after the beginning of the outbreak

7 Level and Predictors of Trauma-symptoms Among Health Workers and Public Service Providers During the COVID-19 Outbreak

The 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.

NCT04374097 Post Traumatic Stress Disorder Anxiety Depression

MeSH:Depression Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

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 Norway

Secondary Outcomes

Description: 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)

Description: 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)

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

8 Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection

The hospitalization of a patient in intensive care is a traumatic experience for his family members. With the current COVID-19 epidemic, in view of the high risk of contamination, drastic measures to limit the transmission are necessary, with the creation of spaces dedicated to the care of Covid+ patients, and family are not allowed to visit. At the Strasbourg University Hospital, visits were prohibited from the start of the epidemic. Information concerning the patient's state of health is therefore delivered to families by telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a serious event at any time. The primary purpose of this project is to assess the psychological impact of the hospitalization of a loved one in intensive care for Covid-19 infection at 3 months post-hospitalization, in a context of pandemic with ban on visits.

NCT04385121 Covid-19 Stress Disorders, Post-Traumatic Anxiety Depression Other: Questionnary

MeSH:Stress Disorders, Post-Traumatic

Primary Outcomes

Description: An overall score of 19 or more indicates a major depressive episode (HAD) and a total score of 22 as in favor of significant symptoms of acute stress (IES-R)

Measure: Existence of a post-intensive care syndrome-family ((combined score of the HAD ( Hospital Anxiety and Dépression scale) and IES-R ( Impact of Event Scale-Revised) questionnaires))

Time: 3 months

9 A Double-blinded Randomized Controlled Trial to Examine the Effectiveness of a Mobile-based Intervention to Reduce Mental Health Problems in Healthcare Workers at the Frontline Against COVID-19 in Spain: the PsyCovidApp Trial

This study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain. The intervention will consist in psychoeducation, delivered via a mobile App. Participants will be followed up during two weeks. The primary outcome will be symptomatology of depression, anxiety or stress.

NCT04393818 Mental Health Disorder Depression Posttraumatic Stress Disorder Burnout Anxiety Disorders Behavioral: Intervention App

MeSH:Disease Anxiety Disorders Stress Disorders, Post-Traumatic Mental Disorders

Primary Outcomes

Description: Depression, anxiety and stress scales (DASS21). Score range: 0 (worst outcome) to 21 (best outcome)

Measure: Depression, anxiety and stress

Time: 2 weeks

Secondary Outcomes

Description: Davidson Trauma Scale (DTS). The DTS is a 17-item, Likert-scale, self-report instrument that assesses the 17 DSM-IV symptoms of PTSD. Both a frequency and a severity score can be determined. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). Higher scores are indicative a worse outcome.

Measure: Post-traumatic stress syndrome

Time: 2 weeks

Description: Insomnia Severity Index. Score range: 0 (best outcome) to 28 (worst outcome)

Measure: Insomnia

Time: 2 weeks

Description: General Self-Efficacy Scale. Score range: 10 (worst outcome) to 40 (best outcome)

Measure: Self Efficacy

Time: 2 weeks

10 Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Test of Replication to a New Population

This research study is designed to investigate the use of a simple cognitive task for decreasing the number of intrusive memories of traumatic events experienced by refugees and asylum seekers with a diagnosis of Post-traumatic Stress Disorder (PTSD) currently living in the UK. The intervention includes a memory reminder cue, a 10-minute time gap and then around 20 minutes playing the mobile phone game Tetris, using mental rotation instructions. The study will have a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants will complete a no-intervention phase of up to three weeks, followed by an intervention phase. Please see the intervention section for more details about the intervention sessions. Follow ups are conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.

NCT04394156 Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma, Psychological Trauma and Stressor Related Disorders Mental Disorder Behavioral: Brief cognitive intervention

MeSH:Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Mental Disorders Psychological Trauma Trauma and Stressor Related Disorders Wounds and Injuries

Primary Outcomes

Description: Number of intrusive memories of traumatic events recorded by participants in a daily pen and and paper diary.

Measure: Frequency of intrusive memories

Time: Baseline weeks 1-3, throughout the duration of the intervention phase (approximately 5 weeks), post-intervention weeks 1-2 and for 1 week 2 months post-intervention. Change is assessed from baseline to post-intervention.

Secondary Outcomes

Description: A brief bespoke measure of concentration adapted from that used previously with refugees (Holmes et al., 2017). It has three questions about disruption to concentration from intrusive memories. A higher score on each question means a worse outcome.

Measure: Concentration

Time: Baseline, 2-weeks post-intervention and 2-months post-intervention

Description: Developed by Woodfield Trauma Service. The measure asks how many hours the person has spent doing various activities in the past two weeks (for example, domestic chores, exercise, cultural activities). A higher score means a better outcome.

Measure: Social and Occupational Activity Tally (SOAT)

Time: Baseline, 2-weeks post-intervention and 2-months post-intervention

Description: Four items from the Dissociative Experiences Scale II - items two, three, 14 and 20 (DES II; Carlson, & Putnam, 1993). Each item asks how often (from 0% to 100% of the time) the dissociative experience described happens to the individual. A higher score on each question means a worse outcome.

Measure: Dissociation

Time: Baseline, 2-weeks post-intervention and 2-months post-intervention

Description: The PCL-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Total scores can range from 0 to 80, with higher scores meaning a worse outcome.

Measure: Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)

Time: Baseline and 2-weeks post-intervention

Description: The PHQ-9 (Kroenke, Spitzer & Williams, 2001) is a nine-item self-report measure that assesses the nine DSM-IV symptoms of depression. Total scores can range from 0 to 27, with higher scores meaning a worse outcome.

Measure: Patient Health Questionnaire (PHQ-9)

Time: Baseline and 2-weeks post-intervention

Description: The WHO DAS 2.0 (World Health Organisation, 2010) is a measure of health and disability. Total scores can range from 0 to 48, with higher scores meaning a worse outcome.

Measure: World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version

Time: Baseline and 2-weeks post-intervention

Other Outcomes

Description: A bespoke measure to assess adherence to self-guided practice of the intervention. It includes four questions to assess how often, and for how long, the person played Tetris after experiencing intrusive memories during the previous week.

Measure: Self-Guided Intervention Adherence Questionnaire

Time: Time Frame: Intervention sessions 2-5, 1 week post-intervention, 2 weeks post-intervention and 2 months post-intervention.

Description: A bespoke questionnaire to gain feedback on the intervention. It includes 16 questions to assess acceptability and usefulness of the intervention with a variety of response options including yes/no, visual analogue scales and open responses.

Measure: Feedback Questionnaire

Time: 1-week post-intervention.

11 Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Pilot Study

This research study was designed to investigate the use of a simple cognitive task for decreasing the number of intrusive memories of traumatic events experienced by refugees and asylum seekers with a diagnosis of Post-traumatic Stress Disorder (PTSD) currently living in the UK. The intervention included a memory reminder cue, a 10-minute time gap and then around 20 minutes playing the mobile phone game Tetris, using mental rotation instructions. The study had a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants completed a no-intervention phase of up to three weeks, followed by an intervention phase. Please see the intervention section for more details about the intervention sessions. Follow ups were conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It was predicted that participants would report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.

NCT04394832 Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Mental Disorder Trauma and Stressor Related Disorders Behavioral: Brief cognitive intervention

MeSH:Disease Stress Disorders, Traumatic Mental Disorders Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders

Primary Outcomes

Description: Number of intrusive memories of traumatic events recorded by participants in a pen and and paper diary.

Measure: Frequency of intrusive memories

Time: Daily through study completion, an average of 3 months. Change is assessed from baseline to post-intervention.

Secondary Outcomes

Measure: Concentration

Time: Baseline and 2-weeks post-intervention

Measure: Social and Occupational Activity Tally (SOAT)

Time: Baseline and 2-weeks post-intervention

Measure: Dissociation

Time: Baseline and 2-weeks post-intervention

Measure: Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)

Time: Baseline and 2-weeks post-intervention

Measure: Patient Health Questionnaire (PHQ-9)

Time: Baseline and 2-weeks post-intervention

Description: The WHO DAS 2.0 (World Health Organisation, 2010) is a measure of health and disability. Total scores can range from 0 to 48, with higher scores meaning a worse outcome.

Measure: World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version

Time: Baseline and 2-weeks post-intervention

Other Outcomes

Measure: Self-Guided Intervention Adherence Questionnaire

Time: Intervention weeks 2-5, 1 week post-intervention and 2 weeks post-intervention

Measure: Feedback Questionnaire

Time: 1-week post-intervention.

12 Effectiveness of Basic Body Awareness Therapy in Survivors of Covid-19, Health Workers and Women Suffering From Gender-based Violence Regarding Post-traumatic Stress Disorders: A Randomized Clinical Trial

The 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.

NCT04396314 PostTraumatic Stress Disorder Behavioral: Basic Body Awareness Therapy Behavioral: Psychological treatment

MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

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 up

Secondary Outcomes

Description: 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 up

Description: 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 up

Description: 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 up

Description: 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 up

Description: 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 up

13 The Professional Peer Resilience Initiative: Leveraging a Data-Driven Model to Maximize the Resilience of Healthcare Workers During the COVID-19 Pandemic

The 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.

NCT04396600 Stress Stress Disorder Stress, Psychological Trauma, Psychological Anxiety Anxiety State Post Traumatic Stress Disorder Secondary Traumatic Stress Professional Quality of Life Stress Related Disorder Stress Reaction Stress Risk Mental Resilience Emotional Resilience Behavioral: MinnRAP Peer Support Program

MeSH:Disease Compassion Fatigue Fractures, Stress Anxiety Disorders Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Stress, Psychological Psychological Trauma

Primary Outcomes

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)

Secondary Outcomes

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)

14 COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder

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.

NCT04401046 Cancer Other: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later

MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

Measure: Score of the Impact of Event Scale Revisited scale

Time: at inclusion and 6 months later

Secondary Outcomes

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 later

Description: The measure of anxiety, measured by the State-Trait Anxiety Questionnaire

Measure: Measure of the patient's anxiety

Time: at inclusion and 6 months later

Measure: proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.

Time: at inclusion and 6 months later

Measure: proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19

Time: at inclusion and 6 months later

Measure: proportion of patients stating that remote consultation is as useful as a face-to-face consultation

Time: at inclusion and 6 months later

Measure: proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)

Time: at inclusion and 6 months later

Measure: Score on the cancer recurrence scale

Time: at inclusion and 6 months later

15 Psychological Impact of the Covid-19 Pandemic on Student Nurses :Prevalence and Risk Factors of Acute Post-traumatic Stress Symptoms 1 Month After the Epidemic Peak

The 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.

NCT04402229 Nurse Student Post Traumatic Stress Disorder COVID-19

MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

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 peak

Secondary Outcomes

Description: 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 peak

Description: 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 peak

16 COVID-19 Caregiver Emotional Support

The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. It also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the ICU, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. Combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. ICU caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. During the patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD). Symptoms of anxiety and PTSD may last for months to years after the patient's discharge. Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief disorder. Supportive interventions may reduce psychological late effects in ICU caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. The CO-CarES study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.

NCT04409821 Posttraumatic Stress Disorder Prolonged Grief Disorder COVID Behavioral: Tele-delivered psychological intervention

MeSH:Disease Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Rate of consent among informed eligible participants

Measure: Recruitment rate

Time: At inclusion

Description: Rates of completion of intervention sessions among participants

Measure: Completion rate

Time: During and post-intervention (1 month)

Description: Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distress

Measure: Peri-traumatic distress inventory (negative emotions)

Time: Pre-post intervention (1 month after discharge/death)

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 1 month post intervention

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 6 months post intervention

Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Measure: Impact of Events Scale (6 item)

Time: 12/13 months post intervention

Secondary Outcomes

Description: Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder

Measure: Prolonged Grief-13-scale

Time: 6 and 13 months

Description: Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptoms

Measure: PROMIS Depression (8 item scale)

Time: Baseline to 1, 6, and 12/13 months

Description: Symptoms of anxiety, min. score 8, max score 40, higher score corresponds to worse symptoms

Measure: PROMIS Anxiety (8 item scale)

Time: Baseline to 1, 6, and 12/13 months

Description: Perceived stress, min. score 0, max score 16, higher score corresponds to worse stress

Measure: Perceived Stress Scale (4 item)

Time: Baseline to 1, 6, and 12/13 months

Other Outcomes

Description: Worry, min. score 3, max score 15, higher score corresponds to greater worry

Measure: Short Penn State Worry Questionnaire (3 items)

Time: Baseline to 1, 6, and 12/13 months

Description: Brooding, min. score 5, max score 20, higher score corresponds to greater brooding/rumination

Measure: Brooding subscale of Ruminative Responses Scale

Time: Baseline to 1, 6, and 12/13 months

Description: Intolerance of uncertainty, min score 2, max score 8, greater score indicates greater uncertainty intolerance

Measure: Intolerance of uncertainty Scale (2 item)

Time: Baseline to 1, 6, and 12/13 months

17 PTSD in Health Workers During COVID-19 Pandemia

The 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.

NCT04424771 COVID Post Traumatic Stress Disorder Behavioral: Maslach Burnout Inventory (MBI)

MeSH:Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

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 months

18 PTSD Symptoms Among Health Workers and Public Service Providers After the COVID-19 Outbreak: A 3 Month Follow up

The 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.

NCT04442243 Post Traumatic Stress Disorder Anxiety Depression

MeSH:Stress Stress Disorders, Traumatic Stress Disorders, Post-Traumatic

Primary Outcomes

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 questionnaire

Secondary Outcomes

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 questionnaire

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 questionnaire

Description: 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 questionnaire

19 Alterations of Gut Microbiome in the Frontline Medical Staff Under the Stress of Fighting Against 2019-nCoV

With the outbreak of 2019 novel coronavirus (2019-nCoV), the frontline medical workers faced enormous stress, including a high risk of infection and inadequate protection from contamination, isolation, patients with negative emotions, a lack of contact with their families, and exhaustion, which may cause mental health problems. The investigators plan to collect the faecal samples and clinical assessments from a part of frontline medical workers in three time points to analyse the changing profile of gut microbiome according to outcomes of 16s rRNA sequencing. The samples from the matched health controls will also be sequenced to compare with the exposed group in gut microbiome community.

NCT04443075 Stress Disorders, Post-Traumatic Device: faecal sample collector

MeSH:Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Gut microbiome composition will be anaylysed using 16S rRNA sequencing.

Measure: Gut microbiome composition of exposed group

Time: immediately after the frontline workers come back to Xi'an

Description: Gut microbiome composition will be anaylysed using 16S rRNA sequencing.

Measure: Gut microbiome composition of exposed group

Time: immediately after the frontline workers isolated for two weeks

Description: Gut microbiome composition will be anaylysed using 16S rRNA sequencing.

Measure: Gut microbiome composition of exposed group

Time: immediately after the frontline workers going back to normal work for one month

Description: Gut microbiome composition will be anaylysed using 16S rRNA sequencing.

Measure: Gut microbiome composition of non-exposed group

Time: During the procedure of collecting faecal samples from exposed group

Description: It's a self-report measure assessing subjective distress resulting from a traumatic life event, with a total score of 0-88. Higher score means a worse outcome

Measure: The Impact of Event Scale-Revised (IES-R) of exposed group