CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D013315: Stress, Psychological NIH

(Synonyms: Stress, Psych, Stress, Psychol, Stress, Psychological)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (36)


Name (Synonyms) Correlation
drug1145 GAD-7 (General Anxiety Disorder) scale Wiki 0.20
drug2658 Software Messaging Wiki 0.20
drug3163 a survey Wiki 0.20
drug2068 Patient management suffering of coronavirus infection Wiki 0.20
drug41 38 questions questionnaire Wiki 0.20
drug2883 The MBSR program (adapted due to COVID-19) Wiki 0.20
drug345 BIIB091 Wiki 0.20
drug1450 Internet-based guided self-help based on CBT principles Wiki 0.20
drug1083 FamilyChildCare (provisional name of app) Wiki 0.20
drug827 Daily Coping Toolkit Wiki 0.20
drug1208 HADS questionnaire Wiki 0.20
drug2271 Psychological stress and adaptation at work score (PSAS) Wiki 0.20
drug1230 Healthy Minds Program Foundations Training Wiki 0.20
drug426 Bivalirudin Injection Wiki 0.20
drug3364 nebulised recombinant tissue-Plasminogen Activator (rt-PA) Wiki 0.20
drug442 Blood plasma Wiki 0.20
drug2196 Positive feedback Wiki 0.20
drug1207 HADS Wiki 0.20
drug1759 Mindfulness Based Intervention Wiki 0.20
drug2028 PHQ-9 (Patient Health Questionnaire) Depression Scale Wiki 0.20
drug2950 Training session adressing information and health literacy Wiki 0.20
drug2263 Prototype swab Wiki 0.20
drug1767 MinnRAP Peer Support Program Wiki 0.20
drug828 Daily Monitoring Wiki 0.20
drug616 Cardiac surgery Wiki 0.20
drug2324 Questionnaires on psychological quality of life Wiki 0.20
drug748 Control swab Wiki 0.20
drug2881 The CRAFT program (adapted due to COVID-19) Wiki 0.20
drug994 Emotional Support Plan Wiki 0.20
drug958 EPDS (Edinburgh Postnatal Depression Scale) Wiki 0.20
drug449 Blood samples Wiki 0.14
drug3437 questionnaire assesment Wiki 0.09
drug2730 Standard treatment Wiki 0.08
drug443 Blood sample Wiki 0.06
drug752 Convalescent Plasma Wiki 0.04
drug2122 Placebo Wiki 0.01

Correlated MeSH Terms (28)


Name (Synonyms) Correlation
D019973 Alcohol-Related Disorders NIH 0.20
D013001 Somatoform Disorders NIH 0.20
D015775 Fractures, Stress NIH 0.20
D011602 Psychophysiologic Disorders NIH 0.20
D015207 Osteoarthritis, Hip NIH 0.20
D000068376 Compassion Fatigue NIH 0.14
D000428 Alcohol Drinking NIH 0.14
D000077062 Burnout, Psychological NIH 0.12
D000073397 Occupational Stress NIH 0.12
D020370 Osteoarthritis, Knee NIH 0.12
D002659 Child Development Disorders, Pervasive NIH 0.12
D000067073 Psychological Trauma NIH 0.12
D010003 Osteoarthritis, NIH 0.10
D007319 Sleep Initiation and Maintenance Disorders NIH 0.10
D001008 Anxiety Disorders NIH 0.09
D000066553 Problem Behavior NIH 0.08
D001321 Autistic Disorder NIH 0.08
D019052 Depression, Postpartum NIH 0.08
D004194 Disease NIH 0.07
D000067877 Autism Spectrum Disorder NIH 0.07
D003863 Depression, NIH 0.06
D003866 Depressive Disorder NIH 0.04
D001523 Mental Disorders NIH 0.04
D040921 Stress Disorders, Traumatic NIH 0.04
D013313 Stress Disorders, Post-Traumatic NIH 0.04
D016638 Critical Illness NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.01
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (8)


Name (Synonyms) Correlation
HP:0008843 Hip osteoarthritis HPO 0.20
HP:0005086 Knee osteoarthritis HPO 0.12
HP:0002758 Osteoarthritis HPO 0.10
HP:0100785 Insomnia HPO 0.10
HP:0000717 Autism HPO 0.08
HP:0000708 Behavioral abnormality HPO 0.08
HP:0000729 Autistic behavior HPO 0.07
HP:0000716 Depressivity HPO 0.04

There are 25 clinical trials

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 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 Hip Osteoarthritis Knee Osteoarthritis Mental Stress Coronavirus 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 Stress, Psychological 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 Mental Stress Mental Health Wellness 1 Depression Anxiety Behavior Problem 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 COVID-19 Burnout, Caregiver Intensive Care Unit Stress, Psychological 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 Covid 19 Stress, Psychological 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 Alcohol Drinking Alcohol-Related Disorders Pandemic 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 Testing the Effects of Two Mindfulness-based Programs on Well Being and Academic Performance of Undergraduate Students of Translation and Interpreting: An Interventional Study

The Faculty of Translation and Interpreting of the University of Granada (UGR) has been leading the lists of the best faculties in this area in Spain and abroad for years. This has largely defined the profile of its students as high performing and, therefore, more prone to display maladaptive perfectionism which can lead to psychological distress (Rice et al 2006). However psychological distress is not something that only affects high profile students. Several studies report overall greater stress levels among undergraduate students when compared to general population levels (Ramasubramanian 2017). In fact, it is estimated that nearly 40 percent of university students experience mild to severe depressive symptoms with over 50 percent of students predicted to experience some level of depressive symptomatology during their college years (Pogrebtsova et al 2018: 46). Coping with cognitive and emotional challenges is therefore a desirable aim for every student on a daily bases. It is within this framework that CRAFTftiugr was born, a teaching innovation project, which is the result of the interaction among experts in mindfulness, lecturers and researchers in Translation and Interpreting and Experimental Psychology, students, Administrative and Support Staff and social stakeholders in the context of Higher Education. The main objective of the study is to test whether participating in a course on mindfulness-based techniques can improve students' cognitive, emotional and personal traits as well as academic performance. Together with this main purpose, the present study also aims to compare the effects of two mindfulness based programs, MBSR and CRAFT, on the students' ability to improve specific aspects of cognition, emotional intelligence, creativity or academic performance among others. Both mindfulness-based programs involve training sustained attention and an accepting and open attitude though they differ in several aspects of their methods, intention and aims. Drawing conclusions from the outcomes, a curriculum applied to Translation and Interpreting Studies will be designed aimed at preventing the development of psychological stress, perfectionism and other anxiety disorders, maximizing comfort in the Higher Education context and, ultimately, improving academic achievement.

NCT04392869 Psychological Distress Life Stress Anxiety Perfectionism Emotional Intelligence Creativity Attention Empathy Behavioral: The CRAFT program (adapted due to COVID-19) Behavioral: The MBSR program (adapted due to COVID-19)
MeSH:Stress, Psychological

Primary Outcomes

Description: A 39-item self-report scale, translated and validated in Spanish, that measures mindfulness traits (Baer et al 2006, 2010; Cebolla et al 2012). Respondents rate a series of statements on a 5-point likert scale, with 1 being "never" and 5 being "very often".

Measure: Change on the Five Facets Mindfulness Questionnaire

Time: Baseline, 4 months

Description: A 10-item self-report scale, translated and validated in Spanish, that measures emotion regulation (Gross and John 2003; Cabello, Salguero, Fernández-Berrocal and Gross 2013). Respondents rate a series of statements on a 7-point likert scale, with 1 being "I strongly disagree" and 7 being "I totally agree".

Measure: Change on the Emotion Regulation Questionnaire

Time: Baseline, 4 months

Description: A 21-item self-report scale, translated and validated in Spanish, that measures depression, anxiety and stress levels (Henry and Crawford 2005, Bados et al. 2005). Respondents rate a series of statements on a 4-point likert scale, with 0 being "not at all true of me" and 3 being "very true of me".

Measure: Change on the Depression Anxiety Stress Scale

Time: Baseline, 4 months

Description: A 30-item self-report scale, translated and validated in Spanish, that measures self-regulation, psychological wellbeing, sociability and emotionality (Petrides et al 2016, Pérez 2003). Respondents rate a series of statements on a 7-point likert scale, with 1 being "I strongly disagree" and 7 being "I totally agree".

Measure: Change on the Trait Emotional Intelligence Questionnaire

Time: Baseline, 4 months

Description: A 20-item self-report scale, translated and validated in Spanish, that measures cultural intelligence (Ang et al 2007; Moyano et al 2014). Respondents rate a series of statements on a 7-point likert scale, with 1 being "I strongly disagree" and 7 being "I totally agree".

Measure: Change on the Cultural Intelligence Scale

Time: Baseline, 4 months

Description: An 8-item self-report scale, translated and validated in Spanish, that measures the levels of the mind wandering trait (Carriere et al 2013). Respondents rate a series of statements on a 7-point likert scale, with 1 being "almost never" and 7 being "almost always".

Measure: Change on the Mind Wandering questionnaire

Time: Baseline, 4 months

Description: Online cognitive test, assessing several objective indices (based on participant's reaction times and accuracy) of attention and vigilance (Luna et al 2018).

Measure: Change on the ANTIVEA task

Time: Baseline, 4 months

Description: Face-to-face questionnaire, in Spanish, measuring divergent thinking (Berná and Limiñana 2010, Elisondo et al 2017).

Measure: Change on the Test on creativity

Time: Baseline, 4 months

Description: A 52-item self-report scale, translated and validated in Spanish, that measures motivation and learning strategies (Rojas-Ospina and Valencia-Serrano 2019; Muñoz and Asencio 2018; Pintrich et al 1987, Pintrich and De Groot 1990; Martínez Fernández and Galán 2000). Respondents rate a series of statements on a 5-point likert scale, with 1 being "I strongly disagree" and 5 being "I totally agree".

Measure: Change on the Motivated Strategies for Learning Questionnaire

Time: Baseline, 4 months

Secondary Outcomes

Description: Results from primary outcome are associated with academic performance of students' core subjects.

Measure: Academic performance assessment

Time: Up to 4 years

Description: This qualitative questionnaire with open ended questions builds directly on the results from the quantitative phase. The quantitative results are interpreted in more detail through the qualitative data.

Measure: Qualitative questionnaire on students' experience

Time: 4 months

9 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 Stress Stress, Psychological 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 mos 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

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

The Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.

NCT04396600 Stress Stress Disorder Stress, Psychological Trauma, Psychological Anxiety Anxiety State Post Traumatic Stress Disorder Secondary Traumatic Stress Professional Quality of Life Stress Related Disorder Stress Reaction Stress Risk Mental Resilience Emotional Resilience Behavioral: MinnRAP Peer Support Program
MeSH:Disease Compassion Fatigue Fractures, Stress Anxiety Disorders Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Stress, Psychological Psychological Trauma

Primary Outcomes

Description: Professional Quality of Life Questionnaire (proQOL): min score of 10; max score of 50; higher scores mean worse outcome

Measure: Change in professional quality of life

Time: Before peer support program, through study completion (an average of 7 months)

Secondary Outcomes

Description: Stress Risk & Resilience Self-Index: min score 0; max score of 12; higher scores mean worse outcome

Measure: Change in mental health symptoms and resilience markers

Time: Before peer support program, through study completion (an average of 7 months)

11 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 Psychological Stress 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

12 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 Anxiety and Fear Anxiety Depression Anxiety Postoperative Psychological Stress Behavioral: HADS 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

13 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 Stress, Psychological Sleep Initiation and Maintenance Disorders 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

14 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 Questionnaire Designs COVID-19 Pandemic Psychological Stress Coping Skills Two-Item Generalised Anxiety Disorder Scale Patient Health Questionnaire An Patient Health Questionnaire Anxiety and Depression Scale Health Status Index Subjective Health Complaint 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

15 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 Anxiety Depression Psychological Stress Psychological Distress Well-being 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

16 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 Postpartum Depression Psychological Stress Maternal Distress Other: PHQ-9 (Patient Health Questionnaire) Depression Scale Other: GAD-7 (General Anxiety Disorder) scale Other: 38 questions questionnaire 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

17 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 Burnout Stress, Emotional 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

18 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 Anticoagulation in COVID-19 ARDS Drug: Bivalirudin Injection 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

19 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 Psychosomatic Disorder Parkinson Psychological Distress Psychological Stress Psychological Disease Psychological Disorder Psychological Impairment Psychological Disability Psychological Adjustment Psychological Adaptation Communication Health Care Seeking Behavior Anxiety Behavior, Health Health Risk Behaviors Healthy Lifestyle 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)

20 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 Stress, Psychological Child Behavior Social Competence 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

21 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 Psychological Distress Stress, Psychological Autism Spectrum Disorder Behavioral: Emotional Support Plan Behavioral: Daily Monitoring
MeSH:Autistic Disorder 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

22 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 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

23 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 Anxiety Depression Stress, Psychological Loneliness 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)

24 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 Critical Illness Family Psychological Stress Covid19 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

25 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 Covid19 Stress, Psychological Work Related Stress Epidemic Disease SARS-CoV Infection 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.


HPO Nodes