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D013315: Stress, Psychological

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (61)


Name (Synonyms) Correlation
drug547 CHAMindWell Wiki 0.18
drug1655 Internet Cognitive Behavioral Therapy plus CHAMindWell Wiki 0.18
drug3449 Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Wiki 0.18
Name (Synonyms) Correlation
drug1257 FamilyChildCare (provisional name of app) Wiki 0.18
drug411 Bereavement Virtual Support Group Wiki 0.18
drug2608 Progressive muscle relaxation Wiki 0.18
drug1104 EPDS (Edinburgh Postnatal Depression Scale) Wiki 0.18
drug3350 Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Wiki 0.18
drug2701 Questionnaires on psychological quality of life Wiki 0.18
drug455 Bivalirudin Injection Wiki 0.18
drug3421 Trauma Informed Psychotherapy Wiki 0.18
drug1375 HADS questionnaire Wiki 0.18
drug1374 HADS Wiki 0.18
drug645 CPI-006 Wiki 0.18
drug1657 Internet-based guided self-help based on CBT principles Wiki 0.18
drug3087 Software Messaging Wiki 0.18
drug1153 Emotional Support Plan Wiki 0.18
drug1319 GAD-7 (General Anxiety Disorder) scale Wiki 0.18
drug2062 Music Therapy Wiki 0.18
drug3352 Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Wiki 0.18
drug3711 brief mindfulness based intervention Wiki 0.18
drug3658 a survey Wiki 0.18
drug646 CRI management Wiki 0.18
drug3409 Transcendental Meditation Wiki 0.18
drug3455 Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Wiki 0.18
drug3188 Stress and emotion management Wiki 0.18
drug428 Bioarginina® Wiki 0.18
drug3462 Two doses of placebo at the schedule of day 0, 14 #middle-dose group# Wiki 0.18
drug3947 placebo rinse Wiki 0.18
drug49 38 questions questionnaire Wiki 0.18
drug2557 Positive feedback Wiki 0.18
drug550 CHX0.12+CPC0.05 oral rinse (PerioAidActive Control) Wiki 0.18
drug2009 Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell Wiki 0.18
drug3097 Spartan COVID-19 v2 System Wiki 0.18
drug3353 Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group# Wiki 0.18
drug2020 MinnRAP Peer Support Program Wiki 0.18
drug3461 Two doses of placebo at the schedule of day 0, 14 #High-dose group# Wiki 0.18
drug957 Daily Coping Toolkit Wiki 0.18
drug4075 vitamin D Wiki 0.18
drug958 Daily Monitoring Wiki 0.18
drug2337 PHQ-9 (Patient Health Questionnaire) Depression Scale Wiki 0.18
drug3354 Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group# Wiki 0.18
drug3319 Thalidomide Wiki 0.18
drug2643 Psychological stress and adaptation at work score (PSAS) Wiki 0.18
drug3281 Telehealth Wiki 0.18
drug2381 Patient management suffering of coronavirus infection Wiki 0.18
drug1397 Healthy Minds Program Foundations Training Wiki 0.18
drug1825 Losartan 50 mg and Spironolactone 25 mg pillules oral use Wiki 0.18
drug3422 Trauma Informed Yoga Wiki 0.18
drug3403 Training session adressing information and health literacy Wiki 0.18
drug2010 Mindfulness Based Intervention Wiki 0.13
drug359 BCG vaccine Wiki 0.09
drug418 Best Supportive Care Wiki 0.09
drug3676 anti-SARS-CoV-2 convalescent plasma Wiki 0.09
drug671 Camostat Wiki 0.08
drug3978 questionnaire assesment Wiki 0.08
drug3166 Standard treatment Wiki 0.07
drug3943 placebo Wiki 0.05
drug864 Convalescent Plasma Wiki 0.03
drug3138 Standard of Care Wiki 0.03
drug2448 Placebo Wiki 0.03

Correlated MeSH Terms (30)


Name (Synonyms) Correlation
D019973 Alcohol-Related Disorders NIH 0.18
D013001 Somatoform Disorders NIH 0.18
D010003 Osteoarthritis, NIH 0.18
Name (Synonyms) Correlation
D020370 Osteoarthritis, Knee NIH 0.18
D011602 Psychophysiologic Disorders NIH 0.18
D015207 Osteoarthritis, Hip NIH 0.18
D015775 Fractures, Stress NIH 0.13
D002659 Child Development Disorders, Pervasive NIH 0.13
D000068376 Compassion Fatigue NIH 0.13
D000067073 Psychological Trauma NIH 0.13
D000428 Alcohol Drinking NIH 0.13
D000077062 Burnout, Psychological NIH 0.12
D007319 Sleep Initiation and Maintenance Disorders NIH 0.10
D001321 Autistic Disorder NIH 0.10
D000067877 Autism Spectrum Disorder NIH 0.09
D001008 Anxiety Disorders NIH 0.09
D000073397 Occupational Stress NIH 0.08
D003866 Depressive Disorder NIH 0.07
D004194 Disease NIH 0.07
D019052 Depression, Postpartum NIH 0.07
D003863 Depression, NIH 0.07
D000066553 Problem Behavior NIH 0.06
D002055 Burnout, Professional NIH 0.06
D006973 Hypertension NIH 0.04
D001523 Mental Disorders NIH 0.04
D040921 Stress Disorders, Traumatic NIH 0.04
D013313 Stress Disorders, Post-Traumatic NIH 0.03
D016638 Critical Illness NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.01
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (9)


Name (Synonyms) Correlation
HP:0002758 Osteoarthritis HPO 0.18
HP:0005086 Knee osteoarthritis HPO 0.18
HP:0008843 Hip osteoarthritis HPO 0.18
Name (Synonyms) Correlation
HP:0000717 Autism HPO 0.13
HP:0000729 Autistic behavior HPO 0.10
HP:0100785 Insomnia HPO 0.10
HP:0000716 Depressivity HPO 0.07
HP:0000708 Behavioral abnormality HPO 0.06
HP:0000822 Hypertension HPO 0.04

Clinical Trials

Navigate: Correlations   HPO

There are 31 clinical trials


1 The COVISTRESS Study: Influence of the COvid-19 Epidemic on STRESS

The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

NCT04308187
Conditions
  1. Stress, Psychological
MeSH:Stress, Psychological

Primary Outcomes

Description: Stress level will be assessed by questionnaire

Measure: Stress

Time: Day 1

Secondary Outcomes

Description: Perception and knowledge of the epidemic will be assessed by questionnaire

Measure: Perception and knowledge of the epidemic

Time: Day 1

Description: The feeling of information will be assessed by questionnaire

Measure: Feeling of information on the part of companies / establishments / governments

Time: Day 1

Description: the means of protection used will be assessed by questionnaire

Measure: Means of protection

Time: Day 1

Description: The feeling of fear and the impact on stigmatization will be assessed by questionnaire

Measure: Feelings of fear generated and its impact on feelings of stigmatization towards ethnic groups or categories of patients

Time: Day 1

Description: Sociodemographic factors and lifestyle habits will be assessed by questionnaire

Measure: Sociodemographic factors and lifestyle habits

Time: Day 1
2 Acceptance and Commitment Therapy Delivered by Automated Software Messaging

This study aims to 1) observe the course of pain, 2) mental status, and 3) possible effect of a behavioral intervention delivered via an automated mobile phone messaging robot in patients were indicated and/or scheduled to undergo joint replacement but have been cancelled or delayed due to the COVID-19 crisis.

NCT04329897
Conditions
  1. Hip Osteoarthritis
  2. Knee Osteoarthritis
  3. Mental Stress
  4. Coronavirus
Interventions
  1. Behavioral: Software Messaging
MeSH:Osteoarthritis Osteoarthritis, Knee Osteoarthritis, Hip Stress, Psychological
HPO:Hip osteoarthritis Knee osteoarthritis Osteoarthritis

Primary Outcomes

Description: PROMIS Pain Intensity 3A short form is a 3 question survey measuring an individual's pain over the past 7 days. It utilizes a scale of 1 (no pain) to 5 (very severe pain) for all questions. The scores for the 3 questions are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 30.7 to 71.8 for the PROMIS Pain Intensity 3A instrument. Higher t-score values represent worse pain outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net

Measure: Change in reported pain intensity score (PROMIS Pain Intensity 3A) Patient-reported outcomes measurement information system Pain Intensity (PROMIS) 3A short form scores collected from all participating subjects.

Time: Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.

Description: PROMIS Pain Intensity 1A short form is a 1 question survey measuring an individual's average pain over the past 7 days. It utilizes a scale of 0 (no pain) to 10 (worst imaginable pain). Higher values represent worse pain outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net

Measure: Change in reported pain intensity score (PROMIS Pain Intensity 1A) Patient-reported outcomes measurement information system Pain Intensity (PROMIS) 1A short form scores collected from all participating subjects.

Time: Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.

Description: The PROMIS Pain Interference 8A short form is an 8 question survey that measures how much pain has interfered in the respondent's life over the past 7 days. It utilizes a scale of 1 (not at all) to 5 (very much) for all questions. The scores for all 8 questions are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 40.7 to 77.0 for the PROMIS Pain Interference 8A instrument. Higher t-score values represent worse pain interference outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net

Measure: Change in reported pain interference score Patient-reported outcomes measurement information system (PROMIS) Pain Interference 8A short form scores collected from all participating subjects.

Time: Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.

Description: The PROMIS Emotional Distress-Anxiety 8A short form is an 8 statement survey that measures how much emotional distress, specifically due to anxiety, a respondent has experienced over the past 7 days. It utilizes a scale of 1 (never) to 5 (always) for all the statements. The scores for all 8 statements are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 37.1 to 83.1 for the PROMIS Emotional Distress-Anxiety 8A instrument. Higher t-score values represent worse anxiety caused emotional distress outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net

Measure: Change in reported emotional distress (anxiety) score. Patient-reported outcomes measurement information system (PROMIS) Emotional Distress-Anxiety 8A short form scores collected from all participating subjects.

Time: Measurements assessed via a computer interface of the standardized form listed above on the day of enrollment and on day fourteen, via telephone.
3 Distress During the COVID-19 Pandemic in France: a National Assessment of At-risk Populations

There are many scales for screening or assessing the impact of a disease. These scales are generally used to diagnose or assess the severity of a disease and are carried out at the request of a physician by the patient. Conversational agents could make it possible to administer these questionnaires remotely, analyse them and use the results on a large scale, without prior medical intervention. The main objective of this study is to quantify and qualify the distress of a large population in times of pandemic crisis.

NCT04337047
Conditions
  1. Stress, Psychological
Interventions
  1. Other: questionnaire assesment
MeSH:Stress, Psychological

Primary Outcomes

Measure: quantify and qualify distress over a large population in times of pandemic crisis.

Time: 1 month

Secondary Outcomes

Measure: qualify demographic data vs distress over a large population in times of pandemic crisis.

Time: 1 month
4 Mental Health Assessment Among Community Member During the Covid-19 Pandemic in Indonesia

The Covid-19 pandemic in Indonesia makes several changes in daily living. The Indonesian government suggests that everyone should stay at home by implements the work from home and school from home. Therefore, the issues related with Covid-19 are also worrying such as death because of the infection, virus transmission, doing everything from home such as Friday praying for Moslem, Sunday service at home, etc. People is anxious whenever meeting people because they are not really understand whether people is infected or not. Therefore, this study tries to identify the impact of Covid-19 pandemic in Indonesia towards mental well-being of the community.

NCT04343664
Conditions
  1. Mental Stress
  2. Mental Health Wellness 1
  3. Depression
  4. Anxiety
  5. Behavior Problem
  6. Emotional Problem
MeSH:Problem Behavior Stress, Psychological
HPO:Behavioral abnormality

Primary Outcomes

Description: The depression symptoms assessed by Patient Health Queationnaire-9 Scale. The range is 0 -27, the highest score means the highest depresive

Measure: Depression

Time: up to 5 minutes

Description: The anxiety symptoms assessed by Generalized Anxiety Disorder -7 Scale. It is consists of 7 item with ranged score 0 -21. The highest score means the highest anxiety

Measure: Anxiety symptoms

Time: up to 5 minutes

Description: The stress related problems assessed by Self Reporting Questionnaire-20 Scale. The range is 0 -20, the highest score means the highest mental health problems

Measure: Stress related problems

Time: up to 7 minutes

Description: Behavior and emotional problem among children and adolescents assessed by Strength and Difficulties Questionnaire. SDQ consists of 25 statements, the score is ranged from 0 - 60. The highest score means the highest problems

Measure: Behavior and emotional problem among children and adolescents

Time: up to 5 minutes
5 Burnout Among Caregivers Facing COVID-19 Health Crisis at a Non-conventional Intensive Care Unit Compared to a Conventional Intensive Care Unit

The intense health crisis due to COVID-19 led to a profound reorganization of the activities at theatres, recovery rooms and the intensive care units. The caregivers are facing several issues and are daily exposed to an intensification of the work. Assessing the stress and the well-being of the caregivers is very important in this context.

NCT04346810
Conditions
  1. COVID-19
  2. Burnout, Caregiver
  3. Intensive Care Unit
  4. Stress, Psychological
Interventions
  1. Other: Patient management suffering of coronavirus infection
MeSH:Burnout, Psychological Stress, Psychological

Primary Outcomes

Description: stress level of caregivers managing patients with coronavirus infection needing airway support or resuscitation. The level of stress will be quantified with the Maslach burnout Inventory.

Measure: Stress in a recovery room transformed into an intensive care unit versus a conventional intensive care unit

Time: A 3 months period from the starting of the pandemic
6 Impact of the COVID-19 Pandemic on the Quality of Psychological Life of Healthcare Professionals

The COVID-19 pandemic is profoundly changing the way people live and work. After the health impact, it is the mental and psychological impact that reaches varying degrees in the entire world population. The previous Asian epidemics have had a lasting impact on the health professionals concerned. In France, no study has yet assessed the psychological impact of this health crisis on the level of health professionals. Investigators propose to study prospectively the evolution of the state of stress and anxiety of all the professionals practicing within the gynecology-obstetrics departments of 18 French hospitals. Investigators also hypothesize that the mental repercussions in terms of stress and anxiety within the same service could be different depending on the professional status and the place of exercise (the French regions being impacted in different ways). In addition to the epidemiological interest, the results of this study may help us to target regions and professionals who will need psychological support during and after this serious health crisis.

NCT04375644
Conditions
  1. Covid 19
  2. Stress, Psychological
Interventions
  1. Other: Questionnaires on psychological quality of life
MeSH:Stress, Psychological

Primary Outcomes

Description: Stress state score, during the confinement period, established by a comparison VAS (visual analogue scale) compared to a period outside COVID-19 (from -5: considerable degradation to +5: considerable improvement, with 0: no change)

Measure: Stress state score, during the confinement period

Time: About 10 minutes ( Questionnaire filling time)
7 COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study

Background: The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global threat to people, communities, and health systems. Researchers are concerned about the mental health effects of the pandemic. They want to learn more about how it is affecting people s alcohol use and problems, and how it may continue to affect them over time. Objective: To study the impact of the COVID-19 pandemic on alcohol use and consequences in individuals across the spectrum of alcohol use and those with alcohol use disorder. Eligibility: Participants who have been screened under the NIAAA Screening, Assessment and Management Protocol (14-AA-0181) Design: Participants will complete a baseline survey by phone. It will ask about alcohol use, alcohol dependence, and stress. It covers 2 time periods: the 12 months before the pandemic started and the time since it started. Participants will get an ID code and a link to an online survey. They will complete the online survey within a week of the phone survey. Participants will complete a series of online surveys over 24 months. For the first year, surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8 weeks, and then every 1-2 months for the rest of the year. For the second year, surveys will be completed every 6 months. Surveys will cover the following topics: - Alcohol use and its consequences - Other substance use - Stress - Impact of the COVID-19 pandemic - Pain - Physical health - Sleep - Quality of life. Because the course of the pandemic may change, the frequency of the surveys may change. Participation lasts 2 years.

NCT04391816
Conditions
  1. Alcohol Drinking
  2. Alcohol-Related Disorders
  3. Pandemic
  4. Psychological Stress
MeSH:Alcohol-Related Disorders Alcohol Drinking Stress, Psychological

Primary Outcomes

Description: Alcohol Use Disorder Identification Test (AUDIT): This is a 10-item questionnaire designed to screen for AUD. The first 3 questions constitute the AUDIT-C and provides a measure of alcohol consumption. The total score provides a continuous quantification of AUD severity.

Measure: AUDIT Score

Time: 24 months

Description: Alcohol Dependence Scale (ADS): This 25-item scale will be used to measure severity of alcohol dependence. This scale covers alcohol withdrawal symptoms, impaired control over drinking, awareness of a compulsion to drink, increased tolerance to alcohol, and salience of drink-seeking behavior.

Measure: ADS Score

Time: 24 months

Secondary Outcomes

Description: Life Events Questionnaire (LEQ): This questionnaire assesses positive and negative life events and their impact on participants

Measure: Life Events Questionnaire (LEQ) Score

Time: 24 monhts

Description: UCLA Loneliness Scale (UCLALS): This is a 20-item scale designed to measure a person s subjective feeling of loneliness and social isolation in the last month

Measure: UCLA Loneliness Scale (UCLALS) Score

Time: 24 months

Description: Perceived stress scale (PSS): This is a 10-item scale to measure perception of stress

Measure: Perceived Stress Scale (PSS) Score

Time: 24 months
8 Pilot Internet-based Self-Help Program for Managing Corona Stress vs. Waitlist Control

The current study examines an adapted guided self-help stress reduction program, focusing on reducing stress in the time of COVID-19. Two studies are planned: 1) an international study in English in which individuals proficient in English throughout the world will participate and 2) a follow-up study in Hebrew.

NCT04394403
Conditions
  1. Stress
  2. Stress, Psychological
Interventions
  1. Behavioral: Internet-based guided self-help based on CBT principles
MeSH:Stress, Psychological

Primary Outcomes

Description: change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.

Measure: The CoRonavIruS Health Impact Survey (CRISIS)

Time: change from Pre to post treatment (6 weeks),

Description: change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.

Measure: The CoRonavIruS Health Impact Survey (CRISIS)

Time: change from Pre to 6 months Follow-up

Description: change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.

Measure: The CoRonavIruS Health Impact Survey (CRISIS)

Time: change from Pre to 1 year Follow-up

Secondary Outcomes

Description: a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.

Measure: Depression, Anxiety, and Stress Scale- 21 item version: DASS-21

Time: Weekly change during treatment and at pre and post (6 week) treatment evaluations

Description: a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.

Measure: Depression, Anxiety, and Stress Scale- 21 item version: DASS-21

Time: change from pre to 6 month follow up

Description: a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.

Measure: Depression, Anxiety, and Stress Scale- 21 item version: DASS-21

Time: change from pre to 1 year follow-up

Other Outcomes

Description: how many modules each individual completes, with less than 2 being considered dropout

Measure: completion rate of modules

Time: 6 weeks
9 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
Conditions
  1. Stress
  2. Stress Disorder
  3. Stress, Psychological
  4. Trauma, Psychological
  5. Anxiety
  6. Anxiety State
  7. Post Traumatic Stress Disorder
  8. Secondary Traumatic Stress
  9. Professional Quality of Life
  10. Stress Related Disorder
  11. Stress Reaction
  12. Stress Risk
  13. Mental Resilience
  14. Emotional Resilience
Interventions
  1. 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)
10 A Daily Coping Toolkit for Medical Personnel and First-Responders During the COVID-19 Pandemic

During the current COVID-19 Pandemic, all communities are relying heavily on medical personnel and first-responders to maintain high levels of psychological and occupational functioning. However, during times of persistent high levels of stress, many individuals experience depletion in psychological resources, suffering intense distress that can make daily occupational and interpersonal functioning difficult. In order to assist with this immense challenge, this research team has developed a brief daily intervention based on decades of stress and trauma research that may help to support psychological health in individuals on the frontlines who are most essential to society. Considerable evidence supports the role of attention to and conceptualization of emotional experience in psychological resilience. This project tests a highly innovative combination of interventions targeting these processes in a brief, daily activity. The primary project aim is to investigate the Daily Coping Toolkit for medical personnel and first responders to determine efficacy over time, to test relative dosing, and to explicate the underlying therapeutic processes. The toolkit consists of 3 activities, administered one time each day, taking minutes to complete and will be administered to n=1000 personnel. Data analysis will test the impact of the toolkit on momentary affective processes and on symptoms and wellbeing over 9 months. The impact of this research will be evidence to support the further use of this novel tool to assist essential front-line personnel during this ongoing crisis helping to mitigate the psychological toll and also support occupational functioning now and in the future.

NCT04398277
Conditions
  1. Psychological Stress
Interventions
  1. Behavioral: Daily Coping Toolkit
MeSH:Stress, Psychological

Primary Outcomes

Description: Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams & Lowe, 2009

Measure: Patient Health Questionnaire - 4

Time: 1 week

Description: Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams & Lowe, 2009

Measure: Patient Health Questionnaire - 4

Time: 9 weeks

Description: Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams & Lowe, 2009

Measure: Patient Health Questionnaire - 4

Time: 26 weeks

Description: Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams & Lowe, 2009

Measure: Patient Health Questionnaire - 4

Time: 40 weeks

Description: 2 items from the WHO-5: Beck 2004

Measure: World Health Organization Well Being Questionnaire

Time: 1 week

Description: 2 items from the WHO-5: Beck 2004

Measure: World Health Organization Well Being Questionnaire

Time: 9 weeks

Description: 2 items from the WHO-5: Beck 2004

Measure: World Health Organization Well Being Questionnaire

Time: 26 weeks

Description: 2 items from the WHO-5: Beck 2004

Measure: World Health Organization Well Being Questionnaire

Time: 40 weeks

Description: Reported negative and positive emotions: Coifman et al, 2016

Measure: Affective Experience

Time: 1 week

Description: Adapted from Hunsley, 1992, assessed subjective experience with intervention

Measure: Treatment Acceptability Questionnaire

Time: 1 week
11 Effect on the COVID-19 Pandemic-induced Reduction in Elective Surgery on Medical Events and Psychological Well-being of Patients Waiting for Cardiac Surgery

The effect and impact of postponing cardiac surgery / creating a waiting list as a result of COVID-19 on patients, both psychologically and symptomatically on three groups of patients: 1. The degree of anxiety and/or depression induced by their altered medical care trajectory. 2. The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit 3. The occurrence of reduced access to medical and psychological help

NCT04406181
Conditions
  1. Anxiety and Fear
  2. Anxiety Depression
  3. Anxiety Postoperative
  4. Psychological Stress
Interventions
  1. Behavioral: HADS
  2. Behavioral: a survey
MeSH:Anxiety Disorders Stress, Psychological

Primary Outcomes

Description: The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

Measure: Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)

Time: 10 minutes

Description: The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.

Measure: Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit

Time: 10 minutes

Description: The occurrence of reduced access to medical and psychological help by means of an adjusted survey.

Measure: Reduced access to medical and psychological help

Time: 10 minutes
12 Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes

Mindfulness training has been gaining popularity in the past decade as a means of improving general well-being. This trend appears in response to the new stressors that have arisen with the increased stress of the 21st century. Studies have shown that the psychological state of metacognitive awareness encapsulated in mindfulness can promote the decreasing of stress as well as the secondary effect of improving sleep quality; both outcome measures of this study. While the body of research evaluating these benefits is growing, there is limited emphasis placed on the individual differences that can affect the overall efficacy of mindfulness training. Our aim in this study is to observe the effects of mindfulness training on perceived stress levels as well as on sleep using subjective measures in a large sample of trainees. To achieve this, participants will be recruited from a pool of people who have signed up for a 4-week foundational mindfulness or 8-week mindfulness based stress reduction course at Brahm Centre. Questionnaires will be administered both before and after these courses to evaluate both stress levels and sleep habits as well as other factors which could contribute to the efficacy of mindfulness training. These inventories will probe the different facets of interpersonal differences that could serve to influence the effectiveness of the mindfulness intervention. In addition, the investigators will also test the effect of conducting the course online during a situation of emergency, like it is the partial lockdown that was implemented in Singapore due to the spread of Covid-19. The proposed study has the potential to provide new insights into the factors that affect the efficacy of mindfulness on stress and sleep, in a situation of non-emergency (until February the 6th 2020) as well as during a period of heightened restrictions (DORSCON Orange, from 7th of February to 6th of April 2020) and a partial lockdown (from 7th of April to 1st of June 2020, or until resume of normal activity). Further, the investigators hope to build an algorithm that can predict the potential effectiveness of mindfulness on a person by person basis. This could serve as a foundation for future recommendations for mindfulness training as well as open the door for future studies that could serve to further customize the mindfulness training framework to accommodate individual differences

NCT04417153
Conditions
  1. Stress, Psychological
  2. Sleep Initiation and Maintenance Disorders
Interventions
  1. Behavioral: Mindfulness Based Intervention
MeSH:Sleep Initiation and Maintenance Disorders Stress, Psychological
HPO:Insomnia

Primary Outcomes

Description: Pittsburgh Sleep Quality Index Score (PSQI) is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The PSQI has a sensitivity of 89.6% and specificity of 86.5% for identifying cases with sleep disorder, using a cut-off score of 5. The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components. A total score, ranging from 0 to 21, is obtained by adding the 7 component scores. A score above 5 suggests poor sleep quality. A decrease in PSQI score following intervention would reflect and improvement of sleep quality

Measure: Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index total Score

Time: Up to one month

Description: The PSS measures whether different aspects of life were perceived as stressful by participants on a 5-point scale (where 0 was never and 4 was very often) in the past month. Positively worded questions are reversed scored and all 10 questions ratings are summarised into a total score, which ranges from 0 to 40, with higher scores indicating more perceived stress.

Measure: Change in subjective measures of Stress: Perceived Stress Scale (PSS)

Time: Up to one month

Secondary Outcomes

Description: Measured within the Pittsburgh Sleep Quality Index questionnaire. This is the total perceived time in bed in minutes, calculated as item 3 of the PSQI ("When have you usually gotten up in the morning?") minus item 1 ("When have you usually gone to bed?")

Measure: Change in Subjective Time in Bed (TIB)

Time: Up to one month

Description: Measured within the Pittsburgh Sleep Quality Index questionnaire. Total sleep time reflects the amount of time in minutes participants were effectively sleeping while in bed, without periods of wakefulness, on average over the past month. This will be measured by item 4 of the PSQI questionnaires: "How many hours of actual sleep do you get at night?".

Measure: Change in Subjective Total Sleep Time (TST)

Time: Up to one month

Description: Measured within the Pittsburgh Sleep Quality Index. This is the perceived time, in minutes, that takes participants to fall asleep from the moment they go to bed. This corresponds to item 2 of the PSQI: "How long (in minutes) has it taken you to fall asleep each night?"

Measure: Change in Subjective Sleep Onset Latency (SOL)

Time: Up to one month

Description: Measured within the Pittsburgh Sleep Quality Index questionnaire. In addition to Sleep Onset Latency (Secondary outcome 1), a second subjective measure of sleep quality is extracted from the PSQI: time of perceived wakefulness occurring after defined sleep onset. WASO is calculated by taking into account the total time spent in bed (TST) minus total sleep time (TST) and minus sleep onset latency (SOL), in minutes. High WASO scores reflect low sleep continuity and poor sleep quality.

Measure: Change in Subjective Wake After Sleep Onset (WASO)

Time: Up to one month
13 Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population

The aim of the study is to explore the psychological effects of the COVID-19 pandemic among Hungarian adults with the use of an anonymous online questionnaire that consists of 65 items. With these results it will possible to identify coping strategies that can help Hungarian adults to deal with the difficulties arising from the pandemic.

NCT04426266
Conditions
  1. Questionnaire Designs
  2. COVID-19 Pandemic
  3. Psychological Stress
  4. Coping Skills
  5. Two-Item Generalised Anxiety Disorder
  6. Two-Item Generalised Anxiety Disorder Scale
  7. Patient Health Questionnaire Anxiety and Depression Scale
  8. Health Status Index
  9. Subjective Health Complaint
  10. Mood
MeSH:Anxiety Disorders Stress, Psychological

Primary Outcomes

Description: 6 items - age, sex, city of residence, marital status, level of education, employment status

Measure: sociodemopraphic factors

Time: 5 months

Description: Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress

Measure: perceived stress

Time: 5 months

Description: The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety

Measure: level of anxiety

Time: 5 months

Description: EQ5D-VAS, 1 item to examine health status

Measure: self-reported health state

Time: 5 months

Description: Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints.

Measure: number of complaints

Time: 5 months

Description: Shortened (Hungarian) version of the Ways of Coping Questionnaire (WOC), 22 items to measure cognitive or behavioral strategies in coping with stressful situations

Measure: strategies in coping with stressful situations

Time: 5 months

Description: psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic, 2 open-ended questions (not obligatory to answer) in connection with psychological effects of the coronavirus pandemic (its effects on the participants' mood and ways of coping with difficulties arising from the pandemic).

Measure: psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic

Time: 5 months

Description: The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression

Measure: level of depression

Time: 5 months
14 COVID-19 and the Healthy Minds Program for Educators

This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. A 3-month follow-up in the fall of 2020 will also be conducted. Participants will be recruited via email and mailed postcards, and will first complete an online screen. Eligible participants will then enter a waiting zone for between 2-days and 2-weeks before they are sent the online pre-test. Upon completion of the pre-test, participants will be assigned to condition via a simple random number generator. If assigned to the intervention (i.e., the Healthy Minds Program App), participants will receive instructions and support in downloading and activating the app. Every 7-days over the 4-week intervention period participants in both conditions will complete the same set of measures. A full battery of measures will be administered a second time post-test, following the 4-week intervention period. Three-months after post-test, a follow-up assessment will be conducted. The investigators predict that participants assigned to the intervention will demonstrate significantly reduced psychological distress after the intervention, and these decreases will persist at the 3-month follow-up. Further, it is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes.

NCT04426318
Conditions
  1. Anxiety
  2. Depression
  3. Psychological Stress
  4. Psychological Distress
  5. Well-being
Interventions
  1. Behavioral: Healthy Minds Program Foundations Training
MeSH:Stress, Psychological

Primary Outcomes

Description: Psychological distress will be assessed by aggregating 3 measures: PROMIS anxiety and PROMIS depression, and the NIH Toolbox Perceived Stress Scale. Averages will be z-scored with a mean of 0 and a standard deviation 1. Higher scores indicate increased psychological distress.

Measure: Change from baseline on an aggregate measure of Psychological distress that averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale

Time: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Secondary Outcomes

Description: A measure of acting with mindful awareness. The total possible range in scores is 8-40, with higher scores indicating greater levels of this facet of mindfulness.

Measure: Change from baseline on the Five Facet Mindfulness Questionnaire Act with Awareness subscale

Time: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: Psychological distancing (i.e., defusion) will be assessed with the 10-item Drexel Defusion Scale (DDS). The total possible range in scores is 0-50, with higher scores indicating greater levels of psychological distancing.

Measure: Change from baseline on the Drexel Defusion Scale (DDS)

Time: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: The Meaning in Life Questionnaire Presence subscale will be used to measure perceptions of meaning and purpose in life. The total possible range in scores is 5 - 35 with higher scores indicating greater levels of meaning.

Measure: Change from baseline on the Meaning in Life Questionnaire

Time: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: A measure of loneliness (i.e, lack of social connectedness). The total possible range in scores is 1-5, representing the average across all items; higher scores indicate greater levels of loneliness.

Measure: Change from baseline on the NIH Toolbox Loneliness scale

Time: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. The perceived coronavirus threat, coronavirus impacts questionnaire, and coronavirus experiences subscales will be summed. The total possible range in scores is 7 - 112 with higher scores representing greater perceived threat.

Measure: Change from baseline on the Conway COVID Questionnaire

Time: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: The Self-Compassion Scale Short Form will be used to measure self-compassion. The total possible range in scores is 12-60, with higher scores indicating greater levels of self-compassion.

Measure: Change from baseline on the Self-Compassion Scale Short Form

Time: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: Negative ruminative thinking will be measured with the Perseverative Thought Questionnaire. The total possible range in scores is 0-60, with higher scores indicating greater levels negative ruminative thinking.

Measure: Change from baseline on the Perseverative Thought Questionnaire

Time: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: Well-being with be measured using the WHO-5. The total possible range in scores is 0-25, with higher scores indicating greater levels of well-being.

Measure: Change from baseline on the World Health Organization 5-item (WHO-5) well-being scale

Time: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for both prosocial construal and bias range from 1 to 7, with higher scores representing greater prosocial construal and bias favoring white faces (negative scores on the bias measure indicate bias for liking black faces more than white faces).

Measure: Change from baseline on the Neutral Face Rating task

Time: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

Description: A measure of fixed versus incremental mindset regarding well-being. The average across items for a possible range in scores from 1-6 will be measured, with higher scores indicating greater levels of incremental views on well-being (i.e., it can be learned).

Measure: Change from baseline on the Growth Mindset Scale for Well-Being

Time: baseline, 4 weeks (post intervention)

Other Outcomes

Description: 4-tems following each app-based practice for treatment participants that ask about perceive quality of the practice, (1 poor, 9 very good), and mood (1 poor, 5 good).

Measure: Slope across time on Practice quality and mood items

Time: Every other day when participant completes a practice (up to 4 weeks)

Description: A measure of working alliance in a digital environment that will be averaged across all items for a score range from 1 to 7, with higher scores reflecting higher levels of alliance.

Measure: Digital working alliance

Time: After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only
15 Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia

The aim of this multicenter prospective study is to evaluate the association between the Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic and anaesthesiologic variables

NCT04437342
Conditions
  1. Postpartum Depression
  2. Psychological Stress
  3. Maternal Distress
Interventions
  1. Other: PHQ-9 (Patient Health Questionnaire) Depression Scale
  2. Other: GAD-7 (General Anxiety Disorder) scale
  3. Other: 38 questions questionnaire
  4. Other: EPDS (Edinburgh Postnatal Depression Scale)
MeSH:Depression, Postpartum Depression Depressive Disorder Stress, Psychological
HPO:Depressivity

Primary Outcomes

Description: Prevalence of postpartum depression during the Covid-19 pandemic with EPDS scale (Edinburgh postnatal depression scale)

Measure: Correlation between the Covid-19 pandemic and postpartum depression with EPDS scale (Edinburgh postnatal depression scale)

Time: 40 days postpartum

Secondary Outcomes

Description: Association between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)

Measure: Correlation between the Covid-19 pandemic, postpartum depression and type of anaesthesia (general, epidural, spinal, combined, epidural analgesia for vaginal delivery)

Time: 10 minutes postpartum

Description: Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)

Measure: Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain

Time: 2 minutes prior to discharge from the Postanaesthesia care unit

Description: Association between the Covid-19 pandemic, postpartum depression and postpartum pain assessed during postanesthesia care unit stay assessed by Numeric Pain Rating Scale (Scale 0-10 where 0 equals no pain and 10 maximum possible pain)

Measure: Correlation between the Covid-19 pandemic, postpartum depression and postpartum pain

Time: 2 minutes after admission to the Postanaesthesia care unit
16 The Impact of Positive Reinforcement on Teamwork Climate, Resiliency, and Burnout During the COVID-19 Pandemic: the TEAM-ICU Study (Transforming Employee Attitudes Via Messaging Strengthens Interconnection, Communication, and Unity)

The COVID-19 pandemic has undoubtedly elevated levels of stress to people all over the globe, but none more than to the providers on the front-line. The purpose of the study is to first, assess the effects of the pandemic on burnout, team cohesion, and resiliency among healthcare providers battling COVID-19 together in a medical ICU (MICU). Secondly, the investigators hope to then assess the effects of simple positive feedback on transforming culture and attitudes during times of major stress.

NCT04441632
Conditions
  1. Burnout
  2. Stress, Emotional
Interventions
  1. Behavioral: Positive feedback
MeSH:Burnout, Psychological Stress, Psychological

Primary Outcomes

Description: The SAQ measures teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions. The six items assessing teamwork climate will be used. 5 point likert scale is used. Mean of the items - 1 * 25 will convert each participant's results to a 100 point scale (0, 25, 50, 75, 100 points).

Measure: Teamwork climate, as measured by selected items from the validated Safety Attitude Questionnaire (SAQ)

Time: 4 weeks

Description: The BRS is comprised of 6 items on a likert scale. Responses varying from 1-5 for all six items give a total range of 6-30. This sum will be divided by the total number of questions for a final score.

Measure: Resiliency, as measured by the validated Brief Resilience Scale (BRS)

Time: 4 weeks

Description: This single item inventory provides 5 definitions of burnout that the participant will choose that most closely fits their personal level of burnout at the moment

Measure: Burnout, as validated by the single-item burnout scale inventory

Time: 4 weeks
17 Anticoagulation in Patients Suffering From COVID-19 Disease-The Anti-Co Trial

Patients with COVID-19 associated ARDS and mechanical ventilation have a high mortality. Part of the disease is an activation of the coagulation system which seems to contribute to clotformation in the pulmonary bloodstream. Recently we implemented an algorithm applying higher doses of heparins (LMWH). However, this approach could not inhibit clotformation enough. Bivalirudin could prevent clotformation better and support dissolving existing clots. Therefore, we want to compare 50 patients with the standard treatment with 50 patients under bivalirudin treatment which we normally apply in patients with a HIT-syndrome. Our primary outcome measure is oxygenation reflected as P/F ratio.

NCT04445935
Conditions
  1. Anticoagulation in COVID-19 ARDS
Interventions
  1. Drug: Bivalirudin Injection
  2. Drug: Standard treatment
MeSH:Stress, Psychological

Primary Outcomes

Description: the P/F ratio is a surrogate parameter for oxygenation in ARDS.

Measure: P/F ratio

Time: three days of intervention

Secondary Outcomes

Description: The kidney function frequently is deteriorated in COVID-19 patients

Measure: Kidney function

Time: three days of intervention
18 Therapies to Achieve Treatment Goals While Being Exposed to Hygiene and Distance Rules: Feasibility and Benefits of Digital Services During the COVID19 Pandemic (Anhand-COVID19)

As a result of the pandemic, hygiene and distancing rules must be followed in Health care/ rehabilitation clinics to ensure the safety of patients and staff. This has led to extensive changes in the therapy processes, including a reduction in group sizes and maintaining distances within the groups, resulting in a reduction in the range of therapies available to individuals, since the number of employees remains unchanged and cannot be increased at will and in the short term due to the lack of qualified staff. In order for the treatment/rehabilitation goals to be achieved nonetheless, new forms of implementation of therapy programs must be developed in addition to organizational adjustments. Digitalization can be a significant support in this respect. The majority of patients in psychosomatic rehabilitation/parkinson treatment possess smartphones, meaning that the necessary infrastructure for the utilization of digital offers is available and can be used to the greatest possible extent. The use of digital measures within the therapeutic services supports the independence of the patients, as they can use the digital offers independently and flexibly in their own time. How should Health care/rehabilitation services be designed in light of the SARS-CoV-2 pandemic and which services have the potential to buffer future crises: What general recommendations can be derived for the design of such services for routine care?

NCT04453475
Conditions
  1. Psychosomatic Disorder
  2. Parkinson
  3. Psychological Distress
  4. Psychological Stress
  5. Psychological Disease
  6. Psychological Disorder
  7. Psychological Impairment
  8. Psychological Disability
  9. Psychological Adjustment
  10. Psychological Adaptation
  11. Communication
  12. Health Care Seeking Behavior
  13. Anxiety
  14. Behavior, Health
  15. Health Risk Behaviors
  16. Healthy Lifestyle
Interventions
  1. Behavioral: Training session adressing information and health literacy
MeSH:Disease Psychophysiologic Disorders Stress, Psychological Mental Disorders Somatoform Disorders

Primary Outcomes

Description: Quantitative online questionnaire Survey using UniPark

Measure: Interest in digital interventions (attitudes, behavioral intentions, behavioral experiences)

Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)

Description: Quantitative online questionnaire Survey using UniPark

Measure: Usability and effectiveness of digital interventions

Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)

Description: Quantitative online questionnaire Survey using UniPark

Measure: Stressors and barriers due to Covid-19

Time: T1 (prior/beginning of rehab/clinic stay); T2 (end of rehab/clinic stay approx. 5 weeks after T1)
19 Adapting and Delivering a Tele-Wellness Supported Digital Toolkit to Baltimore City's Approved Family Child Care Home Providers Caring for Children of Essential Workers: Promoting Health, Early Literacy, and Quality Parent Engagement Amid COVID-19: A Pilot Study

The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a pre-survey is conducted, login information will be assigned to 30 Family Child Care Home providers and parents the FCCH serve. Providers and Parents will receive self-care and parenting/parent engagement support through the app and through a tele-wellness service, Ask a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children will have access to gamified learning materials in early literacy, math, social-emotional learning, and nutrition.

NCT04453657
Conditions
  1. Stress, Psychological
  2. Child Behavior
  3. Social Competence
Interventions
  1. Device: FamilyChildCare (provisional name of app)
MeSH:Stress, Psychological

Primary Outcomes

Description: Family Child Care Home Providers & Parents: Perceived Stress Scale (PSS)-10 is a 10-item tool widely used to measure the degree to which circumstances in one's life are deemed as stressful in the general population. The PSS was designed for use in community samples with at least a junior high school education. The items are easy to understand, and the response alternatives are simple to grasp. Six items of the PSS-10 are negatively phrased (item 1, 2, 3, 6, 9, 10; negative perception subscale, while the remaining four (item 4, 5, 7 and 8; positive perception subscale) are positively phrased items and require reverse coding. Total PSS-10 score will be calculated by summing scores. A total score ranges 0-40 where a higher score indicates higher perceived stress.

Measure: Change in Perceived Level of Stress as assessed by the Perceived Stress Scale

Time: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart

Description: Family Child Care Home Providers & Parents: Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support Short Form 8a assesses the perceived availability of helpful information or advice. It is an 8-item tool and each item has 5 response options ranging in values from one to five-1=Never 2=Rarely 3=Sometimes 4=Usually 5=Always with a range of 8-40. Total raw scores, sum of values to responses, will be calculated. A Score conversion table found in the Appendix of the tool will be used to translate the total raw score or pro-rated score into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.

Measure: Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form

Time: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart

Description: Family Child Care Home providers will be asked in the pre/post-surveys whether they are aware of the existence of the Maryland Early Childhood Family Engagement Framework and Toolkit- a 91-page document developed by the Maryland State Department of Education to guide child care providers in best practices for family engagement. Family Child Care Home providers will respond either i. Yes, I am aware of it but have not read it ii. Yes, I am aware of it and have read the report iii. No, I am not aware of it

Measure: Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question

Time: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart

Description: The social, emotional, and behavioral functioning in children will be assessed by parents responding to items on the Social Competence and Behavior Evaluation for Children: The Short Form (SCBE)-30. It is a 30 item tool with a 6 point response option- Never (1), Sometimes (2 or 3), Often (4 or 5), or Always (6). The SCBE-30 has three subscales (10 items each): Anger-Aggression (cronbach's α = 0.93 in the current sample), Anxiety-Withdrawal (cronbach's α = 0.87), and Social Competence (cronbach's α = 0.89). The SCBE-30 was developed for children from ages three to six and has been shown to have high interrater and test-retest reliability and internal consistency. Sums of each subscale will be calculated.

Measure: Change in Social, Emotional, and Behavior Functioning in Children as assessed by the Social Competence and Behavior Evaluation for Children

Time: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart

Secondary Outcomes

Description: Family Child Care Home Provider and Parents: The Supportive Parent-Caregiver Relationship Sub-scale from Scales Measuring Aspects of Child-Care Quality Supportive Parent-Caregiver Relationship assess the perceived quality of the Parent-Child Care Relationship. The provider report contains 6 items with a 5 point response scale-1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Always. The scale will be adapted to ask about the general relationship to all parents, not any specific parent. The parent report contains 6 items with a 5 point response scale-1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Always. The mean score & alpha will be reported. Reported Mean=26.9, SD=3.4, Alpha=.84)

Measure: Change in Quality of the Parent-Child Care Relationship as assessed by the Supportive Parent-Caregiver Relationship Subscale

Time: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
20 ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease)

The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).

NCT04460677
Conditions
  1. Psychological Distress
  2. Stress, Psychological
  3. Autism Spectrum Disorder
Interventions
  1. Behavioral: Emotional Support Plan
  2. Behavioral: Daily Monitoring
MeSH:Autistic Disorder Autism Spectrum D Autism Spectrum Disorder Child Development Disorders, Pervasive Stress, Psychological
HPO:Autism Autistic behavior

Primary Outcomes

Description: The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress.

Measure: Decreased distress on Patient Health Questionnaire (PHQ-9)

Time: 8 week study period

Description: EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.

Measure: Decreased distress on EMA reports

Time: 8 week study period

Description: The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more anxiety.

Measure: Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)

Time: 8 week study period

Secondary Outcomes

Description: The ASR is a measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.

Measure: Adult Self Report (ASR)

Time: 8 week study period
21 Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare

To Study the epidemiology of psychological distress among healthcare professionals of Max Super Speciality Hospital,Saket ,New Delhi in India during the COVID-19 Pandemic and assess the implications for providing psychological interventions(or therapeutic services)

NCT04469660
Conditions
  1. Psychological Stress
MeSH:Stress, Psychological

Primary Outcomes

Description: The therapeutic sessions will emphasize on aspects of anxiety, depression, grief, post traumatic impact, loss, fear and so on, using standardized therapeutic techniques of psychotherapy. If the individual is in need of further management or somatic symptom related treatment, they will be guided for pharmacotherapy.

Measure: Therapeutic Sessions emphasizing on Stress

Time: 3 Months

Secondary Outcomes

Description: Resilience building and planning will be implemented via individual, group and/or online based training portals to the cohort falling in the range of mild-moderate levels of psychological distress.

Measure: Resilience building and planning

Time: 3 Months
22 Mental Health Impact of the COVID-19 Pandemic Among Immigrants in Santiago, Chile (STRING-COVID)

Evidence suggests that social isolation affects mental health by increasing symptoms of anxiety and depression. One of the main components of the current COVID-19 pandemic is the social isolation imposed on the population. This study seeks to assess the impact of the physical and social living conditions of the pandemic in a cohort of urban immigrants in Chile (i.e. STRING) evaluated six months prior to the pandemic. Specific aims are to 1. Describe the variations in the levels of mental health of immigrants during and after the pandemic, 2. Calculate the effect of social isolation on the levels of mental health of the immigrant population, and 3. Identify risk / protective factors associated with increased mental health problems An online survey will be applied to the STRING cohort at two moments of the pandemic (i.e. during quarantines and after six months).

NCT04497636
Conditions
  1. Anxiety
  2. Depression
  3. Stress, Psychological
  4. Loneliness
  5. Social Isolation
MeSH:Depression Stress, Psychological

Primary 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 scored on a four-point Likert scale (0-3), with the range of scores from 0 to 27. Higher scores indicate greater depression severity, and scores above 10 are considered as the cut-off that indicating that the patient is within the depressive area. Specific cut-off for primary care samples in Chile have been found yielding a cut-off of 7 and above for high sensitivity and specificity (Saldivia, Aslan, Cova, Vicente, Inostroza & Rincón, 2019)

Measure: Depressive symptoms

Time: Month 1 (first follow-up) and month 6 (second follow-up)

Description: The Generalized Anxiety Disorder 7 (GAD-7; Spitzer, Kroenke, Williams & Löwe, 2006) is used to measure symptoms of anxiety and worry. The questionnaire consists of seven items scored on a four-point Likert scale (0-3), with the scores ranging from 0 to 21. Specific cut-off for primary care samples in Spain have been found yielding a cut-off of 10 and above for high sensitivity and specificity (García-Campayo et al, 2010).

Measure: Symptoms of anxiety

Time: Month 1 (first follow-up) and month 6 (second follow-up)

Description: The Impact of Events Scale (IES-R; Weiss & Marmar, 1997) is used to measure symptoms of post-traumatic stress disorder (PTSD). There scale consists of 22 questions which are scored on a five-point Likert scale (0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely). There are three subscales (i.e., avoidance, intrusion, hyperarousal) and the sum of the three subscales scores comprise the total score. A total score ≥33 indicates the likely presence of PTSD using criteria from the Diagnostic Symptom Manual (DSM-IV).

Measure: Symptoms of post-traumatic stress disorder

Time: Month 1 (first follow-up) and month 6 (second follow-up)

Description: Change in visual analogue scale-assessed transdiagnostic measures across all psychiatric symptoms, and World Health Organization (WHO)-5 well-being in the last 2 weeks compared to the last 2 weeks of "regular life" before the COVID-19 outbreak.

Measure: Change in mental health symptoms, well-being from last 2 weeks before the pandemic to last 2 weeks during COVID-19 pandemic

Time: Change from last 2 weeks before pandemic to month 1 (first follow-up)

Secondary Outcomes

Description: Three-Item Revised UCLA Loneliness Scale

Measure: Loneliness

Time: Month 1 (first follow-up) and month 6 (second follow-up)

Description: Change in general physical health, self-rated, on a VAS scale from 0 to 100

Measure: Change in general physical health

Time: Change from last 2 weeks before pandemic to month 1 (first follow-up)

Description: Change in general mental, self-rated, on a VAS scale from 0 to 100

Measure: Change in general mental health

Time: Change from last 2 weeks before pandemic to month 1 (first follow-up)
23 Psychosocial Outcomes in Families of Patients Admitted in ICU for COVID-19 During the Pandemic in Belgium

During the first part of the SRAS-COV2 pandemic, families were not allowed to visit the patients in ICU. We know that families can develop "Family-PICS" after their relatives' ICU stay. The aim of the study is to study the psychosocial outcomes of families of patients who were admitted in ICU for COVID-19 during the pandemic. The second objective was to search for any differences in outcomes whether families benefited from video-conferences with the medical team and their relatives or not during the ICU stay.

NCT04498507
Conditions
  1. Critical Illness
  2. Family
  3. Psychological Stress
  4. Covid19
Interventions
  1. Diagnostic Test: HADS questionnaire
MeSH:Critical Illness Stress, Psychological

Primary Outcomes

Description: sub scores of HADS questionnaire >7

Measure: occurence of anxiety and depression

Time: one month after ICU discharge

Description: sub scores of HADS questionnaire >7

Measure: occurence of anxiety and depression

Time: three months after ICU discharge

Description: IES-R score > 22

Measure: occurence of acute stress

Time: one month after ICU discharge

Description: IES-R score > 36

Measure: occurence of post-traumatic stress disorder

Time: three months after ICU discharge

Description: assessed using the EQ-5D questionnaire

Measure: quality of life

Time: one month after ICU discharge

Description: assessed using the EQ-5D questionnaire

Measure: quality of life

Time: three months after ICU discharge
24 Psychological Impact of COVID-19 Pandemic in Healthcare Workers in Spain: A Cross-sectional Study. PSIMCOV Group

Background. The current coronavirus disease (COVID-19) has a great impact worldwide. Healthcare workers play an essential role and are one of the most exposed groups.Information about the psychosocial impact on healthcare workers is limited. Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional 45-item survey between 9 and 19 April 2020. The objective is to assess the psychological impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and Adaptation at work Score (PSAS) was defined combining four modified versions of validated psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.

NCT04506515
Conditions
  1. Covid19
  2. Stress, Psychological
  3. Work Related Stress
  4. Epidemic Disease
  5. SARS-CoV Infe
  6. SARS-CoV Infection
Interventions
  1. Diagnostic Test: Psychological stress and adaptation at work score (PSAS)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Occupational Stress Stress, Psychological

Primary Outcomes

Description: evaluate the severity of psychological impact of the pandemic in Spain in healthcare workers

Measure: PSAS (Psychological Stress and Adaptation at work Score) during the crisis

Time: during the pandemic (April 9, 2020 to April 19, 2020)

Secondary Outcomes

Description: evaluate the psychological stress in Spain in healthcare workers

Measure: PSAS (Psychological Stress and Adaptation at work Score) in basal conditions

Time: After the pandemic (back to regular activity to be considered in the future as we do not know it yet. It expected to be in less than one year.
25 Operating Under Resilience (OUR) Project: Stress and Emotion Management for Black/African American Women With Hypertension In a Covid--19 Social Distancing Society

Covid-19 is an additional stressor Black women have to deal with that may interfere with hypertension self-care management. Social connectedness is a source of resilience for Black women to promote mental and physical health. Unfortunately, in the face of the Covid-19 pandemic, social distancing is a challenge further isolating Black women from their networks. How is social connectedness to manage stress and emotional well-being in a social-distancing society for Black women with hypertension? The research team proposed a synchronous web-based version of Enhanced Co-Created Health Education InterventioN (eCo-CHIN) that build the success and best practices derived from the original intervention. A Covid-19 session will be included as a way of helping Black women to maintain resilience and self-care during stressful times. The eCo-CHIN intervention is innovative and timely because the research team are using a synchronous platform preparing Black women on how to deal with Covid-19 while taking care of self. The primary investigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator and former KL2 (career development) awardee. The interdisciplinary research team has the expertise and resources to deliver this Enhanced Co-CHIN intervention.

NCT04526145
Conditions
  1. Stress, Psychological
Interventions
  1. Behavioral: Stress and emotion management
MeSH:Hypertension Stress, Psychological
HPO:Hypertension

Primary Outcomes

Description: Weekly participant attendance will be recorded as date, month and year.

Measure: Determine the feasibility of a synchronous web-based health education program, of OUR project.

Time: 4 weeks

Description: Investigator generated open-ended questions.

Measure: Determine the acceptability of a synchronous web-based health education program, of OUR project.

Time: 1 month

Description: Weight measured in pounds.

Measure: Change from baseline at 3 months weight.

Time: Baseline to 3 months

Description: Waist circumference measured in inches.

Measure: Change from baseline at 3 months waist circumference.

Time: Baseline to 3 months

Description: Self-blood pressure collection using an automatic home blood pressure monitor systolic and diastolic in mmHg

Measure: Change from baseline at 3 months blood pressure.

Time: Baseline to 3 months

Secondary Outcomes

Description: Perceived Stress Scale is a 10-item Likert scale questionnaire regarding stress over the past month with higher scores indicating higher levels of stress. Ranges 0-30.

Measure: Change from baseline stress at 3 months.

Time: baseline to 3 months

Description: Difficulties in Emotion Regulation Scale. This measure has 18 items, each measured on a 5-point rating scale. One total score will calculated by summing the individual item responses. Higher scores represent greater perceived difficulties in emotion regulation capabilities.

Measure: Change from baseline emotional regulation at 3 months.

Time: baseline to 3 months

Description: Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q). The DASH Q had 15 items eliciting responses regarding the consumption of DASH diet foods (e.g., fruits, nuts, and vegetables) in the past seven days. Higher score indicates greater DASH knowledge. Range 0-105.

Measure: Change from baseline dietary approaches to stop hypertension knowledge at 3 months.

Time: baseline to 3 months

Description: The Brief Resilience Scale contains 5 questions on a Likert type scale assessing the ability to "bounce back" from stressors. Scores will be summed and higher scores indicate higher resilience.

Measure: Change from baseline resilience at 3 months.

Time: baseline to 3 months

Description: All of Us Program COVID-19 COPE Survey contains items that are not scored on a summary scale, that include social distancing experiences, COVID-19 related symptoms, and COVID-19 related treatment. Descriptive statistics will be used to summarize participant's experiences.

Measure: Describe participant experience and health during the COVID-19 pandemic.

Time: Baseline

Other Outcomes

Description: The Repeatable Neuropsychiatric Battery (RBANS) will be collected. The RBANS consists of 12 subtests that assess cognitive domains such as Immediate and Delayed Memory, Language, Attention, and Visuospatial/Construction and takes about 30 minutes to administer. A total RBANS sum of index scores will be computed by age.

Measure: Explore the feasibility of collecting cognitive performance data (processing speed, attention, and executive function) via teleconference.

Time: baseline and 3 months
26 Investigating the Use of Virtual Music Therapy in Frontline Healthcare Workers During COVID-19

The objective of this project is to investigate the impacts of the COVID-19 pandemic on frontline healthcare workers, and determine if a virtual music therapy can improve mood and emotional state in this population. For this pilot study, EEG will also be used to assess measures of functional connectivity, attention, and mood in adult participants. Participants will also be evaluated for measures of emotion using a standardized test battery (NIH toolbox). This pilot study will show how frontline healthcare workers have been impacted by the COVID-19 pandemic, and provide evidence as to the effectiveness of Music Therapy to support mental health in this essential population.

NCT04551274
Conditions
  1. Mood
  2. Emotional Stress
Interventions
  1. Behavioral: Music Therapy
MeSH:Stress, Psychological

Primary Outcomes

Description: The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.

Measure: Change in Perceived Stress score - NIH Emotion Toolbox

Time: 4 weeks

Description: The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.

Measure: Change in General Life Satisfaction score - NIH Emotion Toolbox

Time: 4 weeks

Description: The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.

Measure: Change in Positive Affect score - NIH Emotion Toolbox

Time: 4 weeks

Description: The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.

Measure: Change in Anger score - NIH Emotion Toolbox

Time: 4 weeks

Description: The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.

Measure: Change in Fear score - NIH Emotion Toolbox

Time: 4 weeks

Description: The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.

Measure: Change in Meaning & Purpose score - NIH Emotion Toolbox

Time: 4 weeks

Description: The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.

Measure: Change in Sadness score - NIH Emotion Toolbox

Time: 4 weeks

Description: The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.

Measure: Change in Emotional Support score - NIH Emotion Toolbox

Time: 4 weeks

Description: The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.

Measure: Change in Loneliness score - NIH Emotion Toolbox

Time: 4 weeks

Secondary Outcomes

Description: Resting-state EEG will be recorded

Measure: EEG - Change in power in the Delta band

Time: 4 weeks

Description: Resting-state EEG will be recorded

Measure: EEG - Change in power in the Beta band

Time: 4 weeks

Description: Resting-state EEG will be recorded

Measure: EEG - Change in power in the Alpha band

Time: 4 weeks

Description: Resting-state EEG will be recorded

Measure: EEG - Change in power in the Theta band

Time: 4 weeks
27 Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use

This 3-arm study compares the effectiveness of an (1) 8-week mindfulness-based intervention, MBCT-R (Mindfulness-Based Cognitive Therapy for Resilience During COVID-19)+CHA MindWell vs. (2) iCBT (internet based Cognitive Behavioral Therapy)+ CHA MindWell vs. (3) CHA MindWell remote monitoring and telephone coaching alone on depressive symptoms as measured over the course of 24-weeks by the computerized adaptive mental health (CAT-MH) interview for depression (CAT-DI). Secondary outcomes include rates and levels of alcohol and drug use, as well as the number of required mental health clinician visits (televisits and in-person visits). Exploratory outcomes include stress-related affect reactivity and salivary inflammatory markers (e.g., interleukin-6).

NCT04595084
Conditions
  1. Depression
  2. Anxiety
  3. Substance Use
  4. Stress, Psychological
  5. Stress, Emotional
  6. Alcohol Use, Unspecified
  7. Drug Use
  8. Covid19
Interventions
  1. Behavioral: Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell
  2. Behavioral: Internet Cognitive Behavioral Therapy plus CHAMindWell
  3. Behavioral: CHAMindWell
MeSH:Depression Depressive Disorder Stress, Psychological
HPO:Depressivity

Primary Outcomes

Description: Change in depression symptom severity as measured by CAT-MH Depression Inventory (DI) scores completed at baseline and every 4 weeks during the 24 weeks after randomization. Difference between MBCT-R arm and CHA-MW monitoring alone arm is primary outcome. Difference between iCBT arm and CHA-MW monitoring alone arm is secondary outcome. Difference between iCBT arm and MBCT-R is an exploratory outcome.

Measure: Depression Severity (CAT-DI)

Time: Baseline, Weeks 4, 8, 12, 16, 20, 24

Secondary Outcomes

Description: Rates of positive toxicology screens for illicit drugs or unprescribed controlled substances at 24 weeks. Rates of positive toxicology for illicit drug use or controlled substances (non prescribed) at week 24 is the secondary outcome.

Measure: Drug Use Rates

Time: Week 24

Description: We will conduct an Alcohol Use History at Week 24. We will conduct 30-day alcohol and substance use history using the TimeLine Follow Back (TLFB) Method at Week 24 visit by telephone or video conference. Heavy Drinking Days in past 30 days is the secondary outcome.

Measure: Heavy Drinking Days

Time: Week 24

Description: Number of mental health clinician televisits during 24 weeks

Measure: Televisits

Time: Randomization through Week 24

Other Outcomes

Description: Participants report the frequency of emotions using a 5-point scale: 0 = none of the time, 1 = a little of the time, 2 = some of the time, 3 = most of the time, 4 = all of the time. The NA scale consists of 14 items: restless or fidgety, nervous, worthless, so sad nothing could cheer you up, everything is an effort, hopeless, lonely, afraid, jittery, irritable, ashamed, upset, angry, and frustrated. The PA scale consists of 13 items: in good spirits, cheerful, extremely happy, calm and peaceful, satisfied, full of life, close to others, like you belong, enthusiastic, attentive, proud, active, and confident. Daily NA and PA are calculated by averaging the items within each subscale, and then aggregating scores across interview days.

Measure: Positive and Negative Affect Reactivity Scales

Time: Weeks -4, -3, -2, -1, 0, 9, 10, 11

Description: The Daily Inventory of Stressful Events is used to assess whether each of 7 types of stressors occurred in the past 24 hours: argument, avoided an argument, stressor at work or school, stressor at home, discrimination, network stressor (i.e., stressful event that happened to a close friend or family member), and any other stressor. A day is categorized as a "stressor day" if the participant endorsed at least one stressor, or a "nonstressor day" if the participant indicated that no stressors occurred. Stressor frequency is defined as the percentage of interview days during which at least one stressor occurred. Salivary Cytokine Panels will be collected on two of these stressor and non stressor days respectively.

Measure: Daily Inventory of Stressful Events

Time: Weeks -4, -3, -2, -1, 9, 10, 11, 12

Description: Difference between mean level of salivary Interleukin-6 during 2 low stressor and 2 high stressor days is exploratory outcome. Evening salivary passive drool samples (which assess TNF-a, IL-1b and IL-8 in addition to IL-6) will be collected 4 times during weeks -4-0 and 4 times during weeks 9-12 during diary collection. They will be primed with REDCAP branching logic activated by 2 multi-stressor (high) stressor days and 2 no stressor days. REDCAP will specifically tell them to select a color/letter coded sampling contained and they will collect that sample that evening. They will place samples immediately in the freezer.

Measure: Inflammatory Cytokines (IL-6, IL-1b, IL-8, TNF-a)

Time: Weeks -4, -3, -2, -1, 9, 10, 11, 12

Description: A 15-item scale with content from six dimensions of experiential avoidance.

Measure: Brief Experiential Avoidance Questionnaire (BEAQ)

Time: Baseline, Weeks 4, 8, 12

Description: The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation using a 5 point Likert scale. The scale assesses 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Subscales are summed and a lower total score represents a better outcome. Individual subscales will also be assessed.

Measure: Difficulties in Emotion Regulation Scale (DERS)

Time: Baseline, Weeks 4, 8, 12

Description: The Perceived Stress Scale (PSS-14) (14 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often).

Measure: Perceived Stress Scale (PSS-14)

Time: Baseline, Weeks 4, 8, 12, 24

Description: The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored.

Measure: Self-Compassion Scale Short Form (SCS-SF)

Time: Baseline, Weeks 4, 8, 12

Description: The Multidimensional Assessment of Interoceptive Awareness (MAIA-2) is a 37 item self-report scale designed to assess multiple aspects of interoception and interoceptive awareness. The scale assesses 8 aspects of interoceptive awareness: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Subscales are summed and a higher total score represents a better outcome. Individual subscales will also be assessed, especially Body Listen, Body Trust, and Self-Regulation.

Measure: Multidimensional Assessment of Interoceptive Awareness (MAIA-2)

Time: Baseline, Weeks 4, 8, 12

Description: The adult self-report COVID-19 Responses to Stress Questionnaire is a 72-item survey. Responses are recorded on a 4-point Likert scale (1 = Not at All, 4 = Very/A lot). Items in the RSQ cover 5 factors of coping and stress responses: primary control engagement coping (i.e., problem solving, emotional expression, emotional modulation), secondary control engagement coping (i.e., positive thinking, cognitive restructuring, acceptance, distraction), disengagement coping (i.e., avoidance, denial, wishful thinking); involuntary engagement (e.g., physiological arousal, rumination), and involuntary disengagement (e.g., emotional numbing).

Measure: Responses to Stress Questionnaire - COVID -19 (RSQ-COVID-19) Stress coping style (disengagement, involuntary engagement)

Time: Baseline, Weeks 12, 24

Description: This is a 20-item self-report measure of decentering and is conceptualized as a protective factor and capable of measuring resilience to depressive relapse. The EQ uses a 5-point Likert scale with responses from "never" to "all the time". A sample item from the decentering subscale is "I can observe unpleasant feelings without being drawn into them."

Measure: Experiences Questionnaire (EQ) (Rumination and Decentering)

Time: Baseline, Weeks 4, 8, 12

Description: Computer Adaptive Testing for Mental Health (CAT-MH) interviews are diagnostic interviews designed to be completed online using a computer, tablet or phone. Items from each of the modules for depression (CAT-DI), anxiety (ANX-CAT), mania and hypomania (M/HM-CAT), PTSD (PTSD-CAT), psychosis (PSY-S-CAT), suicidality (SS-CAT), and substance abuse (SUD-CAT) are chosen from large item banks based on multidimensional item response theory, adapting each item presented to the individual's severity so that different individuals are tested with different items depending on their severity level.

Measure: Computerized Adaptive Testing for Mental Health (CAT-MH) Interviews

Time: Screening, Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24

Description: The Beck Depression Inventory (BDI-II) is a 21-item self-report scale designed to assess depression severity over the past 2 weeks with well-established internal consistency, reliability and validity.

Measure: Beck Depression Inventory (BDI-II)

Time: Baseline

Description: Rank Desire for each intervention option will be assessed at baseline.

Measure: Rank Desire

Time: Baseline

Description: Credibility/Expectancy for the assigned option will be assessed at Week 2. Treatment expectancy and credibility for each arm will be assessed with the 4-item Credibility/ Expectancy Questionnaire (CEQ)

Measure: Credibility and Expectancy

Time: Week 2

Description: The COVID-19 Fear scale is a 7-item questionnaire recorded on a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). Responses to scale items were found to positively correlate with perceived vulnerability, hospital anxiety, and depression. Sample questions include "I am most afraid of coronavirus-19," and "It makes me uncomfortable to think about coronavirus-19."

Measure: COVID-19 Fear

Time: Baseline, Week 12

Description: Participants will be asked to self-report on REDCap.

Measure: COVID-19 status (self-report)

Time: Week 0, 4, 8, 12, 16, 20, 24

Description: Participants will be asked to complete a salivary sample to assess COVID-19 status. COVID-19 IgG samples: Antibodies for COVID-19 will be sampled at week 12 among all participants to establish whether they were exposed to COVID-19 during the study. They will place samples immediately in the freezer.

Measure: COVID-19 status (salivary IgG)

Time: Week 12

Description: The UCI Oral Health Questionnaire is an 12-item survey that asks sociodemographic questions, questions about oral and physical health, as well as additional oral health questions drawn from the WHO Oral Health Survey. The questionnaire includes basic questions about dental health characteristics of participants to be used as an exclusion criteria for the salivary collection portion of the study and to track changes in oral health that might impact salivary data collection.

Measure: UCI Oral Health Questionnaire

Time: Screening and at Week 12

Description: The Home Skills Use Diary will be completed for the 8 weeks during the intervention period and will come in two types (1: weekly mindfulness practice and resource use diary for the MBCT-R group and 2: General CBT coping skills use diary card for both the iCBT and CHA MindWell arms).

Measure: Home Skills Use Diary

Time: Weeks 1, 2, 3, 4, 5, 6, 7, 8

Description: The Adverse Event Patient Participant Self-Report Form will be systematically assessed at assessment timepoints (baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks and 24-weeks). In addition, group leaders and research coordinators will be trained to identify and report any adverse events that occur or are reported during weekly group visits.

Measure: Adverse Event Patient Participant Self-Report Form

Time: Baseline, Weeks 4, 8, 12, 16, 20, 24
28 Improving Health and Wellness During COVID-19

There is an immediate need for population-level intervention research to address the impacts of the coronavirus disease 2019 (COVID-19) pandemic and its containment measures on mental health and substance use (MHSU). While online programs are available to address these issues, they are often delivered in an asynchronous format with relatively low therapist or health coaching guidance. As highlighted by a recent systematic review, positive outcomes for online mental health programs are tied to the intensity of therapist or coaching guidance, which increases cost and reduces population access to more effective online options. A way to offset cost while maintaining effectiveness is to offer MHSU programs to groups online, rather than individually. In 2019, the investigators launched an RCT to test gender-stratified group interventions to address MHSU among community-based Indigenous and non-Indigenous adults in southern Alberta. The investigators implemented the interventions with more than 200 adults before the study was paused due to COVID-19.

NCT04615741
Conditions
  1. Mental Health Wellness 1
  2. Addiction
  3. Stress, Psychological
  4. Covid19
Interventions
  1. Behavioral: Trauma Informed Yoga
  2. Behavioral: Trauma Informed Psychotherapy
MeSH:Stress, Psychological

Primary Outcomes

Description: Participants will be asked to self-report if tobacco use has changed during the pandemic via a 5-point likert. Options range from increased a lot to decreased a lot. If participants indicate their tobacco use has changed, they will be asked to identify the primary reason for this change. Changes in tobacco use will be re-assessed at each time point.

Measure: Changes in Tobacco Use

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: Past year alcohol consumption will be assessed through the Alcohol Use Disorder Identification Test (AUDIT). Scores on the AUDIT range from 0 to 40; a score over 8 is indicative of problematic or hazardous alcohol use. Changes in alcohol consumption since the beginning of the pandemic will be identified through a 5-point likert. Changes in alcohol use will be re-assessed at each time point.

Measure: Changes in Alcohol Use

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: Past year drug use will be assessed through the Drug Use Disorders Identification Test (DUDIT). Possible scores on the DUDIT range from 0 to 44; scores greater than 2 or 6 are indicative of risky or harmful drug habits for women and men, respectively. A score of 25 or more suggests the individual is probably heavily dependent on drugs. Participants will also be asked to identify which drugs they currently use, the main reasons for using drugs, and whether their drug use has changed during the pandemic. Changes in drug use will be re-assessed at each time point.

Measure: Changes in Drug Use

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: Gambling will be assessed via the 9-item Problem Gambling Severity Index (PGSI). The items are measured on a 5-point likert with frequencies from "less than once a month" to "daily or almost daily". A cut-score ≥5 will be used (lower scores indicative of non-problem gambling); the PGSI has a high internal consistency (α = 0.86) and is considered the measure of choice for non-clinical use.

Measure: Changes in Gambling

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: A revised version of the Primary Care - Post Traumatic Stress Disorder - 5 (PC-PTSD-5) scale will be assessed to determine experiences of trauma in relation to COVID-19. The scale was revised to specifically ask about COVID-19. Scores range from 0 (no risk) to 5 (high risk). A cut-score of 3 will be used to differentiate high- and low-risk scores. The PC-PTSD has good sensitivity (r = 0.78) and sensitivity (r = 0.87).

Measure: Changes in Post-Traumatic Stress Symptoms

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: Depression will be screened using the 10-item Centre for Epidemiological Studies Depression Scale (CES-D-10). The CES-D-10 is a short self-report scale to measure depressive symptoms in a general population. Psychometric evaluation has shown the CES-D-10 to have high internal consistency, though with variability across populations (Cronbach's α = 0.71 to 0.90) and good construct validity (r = 0.78).

Measure: Changes in Depression Symptoms

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: The 6-item State-Trait Anxiety Inventory (STAI-6) will be used to measure anxiety reflective of both adverse situations (state anxiety) and personality traits associated with higher levels of anxiety (trait anxiety). STAI-6 produces scores like its longer 20-item version, showing good reliability (Cronbach's α = 0.82) with sensitivity to differing degrees of anxiety. Possible scores range from 20 to 80; "normal scores" range from 34 to 36. Higher scores represent higher amount of anxiety.

Measure: Changes in Anxiety Symptoms

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Secondary Outcomes

Description: Changes in eating behaviours will be assessed by questions asking if food consumption and unhealthy food consumption have changed since the onset of the pandemic via a 5-point likert scale (increased a lot to decreased a lot). If participants indicate they have changed their food consumption, a qualitative question will ask them to describe why they think their behaviour has changed.

Measure: Changes in Eating Behaviour

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: Participants will be asked to rate how the quantity and quality of their sleep has changed since the pandemic started via 5-point likert scales (increased a lot to decreased a lot).

Measure: Changes in Sleeping Behaviour

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: Physical activity will be assessed through the International Physical Activity Questionnaire - Short Form. The questionnaire asks about frequency and duration of vigorous (VPA) and moderate physical activity (MPA) over the past 7 days. Weekly Metabolic Equivalents (MET) minutes will be calculated based on responses. Participants will be categorized into high (>1500 MET min/week with 3+ days of VPA or >3000 METmin/week with 7+ days of MVPA); medium (5+ days of 20+ minutes of VPA per day, 5+ days with 30+ minutes of MPA per day, or 5+ days of MVPA that achieves 600+ MET min/week); low (participant does not meet other cut points). Frequency and duration of walking and sitting time are also assessed. The IPAQ has good reliability and criterion validity. Participants will also be asked if their PA and sedentary behaviour levels have changed during the pandemic (5-point likert; options: increased a lot to decreased a lot).

Measure: Changes in Physical Activity

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: The 10-item Connor-Davidson Resilience Scale (CD-RISC 10) is a widely used measure to assess self-perceived resilience. Evaluations of the CD-RISC 10 have shown good internal consistency (Cronbach's α = 0.85), a strong positive association with the longer 25-item CD-RISC (r = 0.92). Scores range from 0 to 40; a higher score is indicative of higher resilience.

Measure: Changes in Resilience

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: Self-esteem will be measured using the 10-item Rosenberg Self Esteem Scale. The scale is a widely used measure that correlates well with other measures of self-esteem and has strong internal consistency (0.92) and test-retest reliability (0.88). Scores range from 4 to 40; a higher score indicates higher self esteem. Participants will also be asked how their self-esteem has changed since the beginning of the pandemic.

Measure: Changes in Self-Esteem

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: Loneliness will be evaluated using a shortened (3 item) version of the UCLA Loneliness Scale. This scale asks about feelings of companionship, being left out, and being isolated from others in the last month, with a 3-item list of answer options (hardly ever, some of the time, often). This scale has good reliability (r = 0.73), validity, and internal consistency (Cronbach's α = 0.84-0.94). The scale also showed convergent validity with other commonly used measures of loneliness. Scores range from 1 to 9; higher scores indicate higher levels of loneliness.

Measure: Changes in Loneliness

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: The Brief Dissociative Experiences Scale is an 8-item tool that assesses the severity of dissociative experiences in adults. The scale items are summed and averaged to describe the severity of dissociative experiences as none (0), mild (1), moderate (2), severe (3), or extreme (4). The brief scale was found to be reliable, easy to use, and clinically useful in the DSM-5 Field Trials. Scores range from 0 to 32; a higher score indicates a greater severity of dissociative experiences.

Measure: Changes in Dissociative Experiences

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Other Outcomes

Description: Coping strategies and perceived ability to cope during the pandemic will be assessed through four self-reported questions. Participants will be asked how well they are coping with the pandemic on a 5-point likert, options will range from 'excellent' to 'poor'. Participants will be asked to identify things that are helping them to cope from a list of 18 items. Current life satisfaction will be assessed with a single question with options ranging from "very satisfied" to "very dissatisfied". Participants will also be asked to identify up to 3 things they wish they could change right now in their life.

Measure: Changes in Coping Strategies

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Description: Participants will be asked to self-report feelings of belonging to their local and work communities. They will also be asked to self-report changes to the quality or stress associated with their romantic relationships and the presence of abuse.

Measure: Changes in Relationships and Belonging

Time: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
29 Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic

This single blind, randomized, controlled trial (RCT) evaluates, a nonpharmacological intervention, TM (Transcendental Meditation) for improving burnout (, as measured by self-reporting (survey), physiologic, and neuro-functional imaging studies in health care providers (HCPs) when practiced over 3 months' time. The investigators define HCPs as any physician, physician trainee, nurse, physician assistant, nurse practitioner or respiratory therapist. HCPs will be screened by a single-item stress scale and Columbia Suicide Severity Rating Scale (CSSRS) to understand their stress level and exclusion criteria respectively. The Global Severity Index of the Brief Symptom Inventory (BSI)-18 Global Severity score will be used as the primary outcome for pre- and post-TM training (baseline, 1 vs. 3 months). In addition, the investigators will evaluate physiological markers of stress and cardiovascular resiliency such as 1) changes (pre/post-treatment) in heart rate variability (HRV) through wearables, 2) Galvanic Skin Response (GSR) - changes in sweat gland activity that result from changes in an emotional state. fMRI will be performed by the Duke Brain Imaging and Analysis Center (BIAC) on a subset of participants to evaluate changes A specifically developed mobile app will aid data collection as well as reminders for providers to aid compliance for meditation

NCT04632368
Conditions
  1. Burnout, Professional
  2. Stress, Psychological
Interventions
  1. Behavioral: Transcendental Meditation
MeSH:Burnout, Professional Burnout, Psychological Stress, Psychological

Primary Outcomes

Description: Changes in brief symptom inventory as evaluated by BSI 18

Measure: change in self reported Stress symptoms

Time: Baseline, 1 month, 3 months

Secondary Outcomes

Description: These will include secondary outcomes as measured by the Connor Davidson Resilience Scale-25 (CD-RISC).

Measure: Change in self reported resilience

Time: Baseline, 1 month, 3 months

Description: Change in symptoms of depression will be measured by PHQ 9 scale

Measure: Change in symptoms of depression

Time: Baseline, 1 month, 3 months

Description: Change in insomnia symptoms as measured by Insomnia severity Index(ISI)

Measure: Change in insomnia symptoms

Time: Baseline, 1 month, 3 months

Description: Change in anxiety symptoms as measured by GAD-7

Measure: Change in anxiety symptoms

Time: Baseline, 1 month, 3 months

Description: change in psychological distress as measured by the Global Severity Index of the Brief Symptom Inventory (BSI)-18 questionnaire.

Measure: Change in psychological distress

Time: Baseline, 1 month, 3 months

Description: Change in burnout symptoms in HCPs as measured by Maslach Burnout Inventory( MBI)

Measure: Change in self reported burnout symptoms

Time: Time Frame: Baseline, 1 month, 3 months
30 Benefit of Treatment With Losartan and Spironolactone on the Regulation of the Renin-angiotensin System in the Prognosis of Patients Infected With COVID-19 and Suffering From Acute Respiratory Distress Syndrome

Coronavirus disease (COVID-19) is a current pandemic infection caused by an RNA virus called Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). Severe forms of COVID-19 are most often responsible for isolated respiratory failure in the form of acute respiratory distress syndrome (ARDS), which accounts for most of the mortality. Angiotensin converting enzyme 2 (ACE2) has been shown to be a co-receptor for the entry of SARS-CoV-2 into cells and is likely to play a prolonged role in the pathogenesis of COVID-19. ACE2 and angiotensin (1-7) have been shown to be protective in a number of different lung lesion models. In a mouse model of acidic lung injury, negative regulation of ACE2 by COVID, the SARS virus responsible for the 2003 SARS outbreak, worsened the lung injury which was improved by treatment with ARBs. We believe that blocking the first RAS pathway at the end of the chain on the AT1r angiotensin 2 receptor may prevent the initiation of this chain reaction and limit decompensation secondary to the disruption of the equilibrium of the renin-angiotensin system. We have several molecules that block the AT1r angiotensin-2 receptor (ARBs) as well as a molecule that blocks the secretion of aldosterone (spironolactone). The main objective is to demonstrate the value of losartan and spironolactone therapy in the regulation of the renin-angiotensin system in improving the prognosis of patients infected with COVID-19 and suffering from acute respiratory distress syndrome. This is a prospective, multicenter, randomized, open-label, controlled, therapeutic trial studying two parallel groups. The population included in this study is any major patient in acute respiratory distress hospitalized in intensive care requiring oxygen support of at least 6L/min and suffering from a PCR-confirmed SARS-cov2 infection. The control group will benefit from the usual resuscitation management of COVID19 , and the experimental group will benefit from losartan and spironolactone treatment in addition to the usual management, according to the study protocol. The number of subjects required has been calculated and 45 patients for each group, for a total of 90 patients. The SOFA score at D7 will be compared between the "experimental" versus "control" groups using a mean comparison method. The comparison of this criterion and all secondary criteria of judgments between the 2 groups will be performed using a Student or Mann-Whitney test based on the normality of the distribution. The significance threshold will be set at 0.05. No intermediate analysis is scheduled. The analysis will be blinded. The main expected outcome is an improved prognosis with a decrease in the SOFA severity score at 7 days in resuscitation patients, resulting in an improvement in organ failure. The expected secondary results will be to show the interest of ARA2/Spironolactone treatment on oxygenation based on the PaO2/FiO2 ratio, mechanical ventilation duration and mortality.

NCT04643691
Conditions
  1. COVID-19
  2. ARDS
Interventions
  1. Drug: Losartan 50 mg and Spironolactone 25 mg pillules oral use
MeSH:Stress, Psychological

Primary Outcomes

Description: Organ failures will be assessed on the SOFA score on day 7 post-inclusion.

Measure: SOFA score

Time: 7 days (J7)

Secondary Outcomes

Description: Oxygenation will be assessed using the PaO2/FiO2 ratio on the 3rd, 7th, 14th, 21st, 28th day after inclusion

Measure: Pa02/Fi02

Time: day 3; day 7; day 14; day 21 and day 28

Description: The duration of mechanical ventilation will be evaluated by the number of days of ventilation, the number of days without ventilation between inclusion and death or D28

Measure: Duration of mechanical ventilation

Time: 28 days

Description: Mortality will be measured by: mortality at D28, hospital mortality, ICU mortality.

Measure: Death

Time: 28 days
31 Brief Mindfulness Based Intervention for Front-Line Medical Staff in the COVID19 Pandemic to Improve Psychological Wellbeing, a Randomized Controlled Multicenter Trial

our aim is to evaluate the effectiveness of virtual brief mindfulness based interventions on psychological wellbeing, resiliency, and anxiety of frontline HCP to cope for (COVID19) stressors

NCT04656626
Conditions
  1. Stress, Psychological
Interventions
  1. Behavioral: brief mindfulness based intervention
  2. Behavioral: Progressive muscle relaxation
MeSH:Stress, Psychological

Primary Outcomes

Description: assessed using the (state trait anxiety-7 Item Scale); ranged from 10-40, higher score indicate more anxiety

Measure: reduction of anxiety symptom severity

Time: 14 days

Description: assessed using the (Connor-Davidson Resilience Scale (CD-RISC)); score from 0-40, higher scores indicate more resilience

Measure: change in the level of psychological resilience

Time: 14 days

Secondary Outcomes

Description: assessed by World Health Organization wellbeing scale; changed to percent score, the higher the better.

Measure: mental wellbeing

Time: 14days

Description: 12-Item Short Form survey

Measure: and functional status

Time: 14 days

HPO Nodes


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Reports

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.

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