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D000077062: Burnout, 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 (41)


Name (Synonyms) Correlation
drug829 Colchicine Wiki 0.33
drug918 Coping strategies video Wiki 0.28
drug2598 Positive feedback Wiki 0.28
Name (Synonyms) Correlation
drug886 Control Period Wiki 0.28
drug801 Clevudine Wiki 0.28
drug809 Clinolipid Wiki 0.28
drug3663 Virtual Peer Support Platform Wiki 0.28
drug2633 Prednisone tablet Wiki 0.28
drug3062 Self Study Wiki 0.28
drug2115 N-95 Respirator Wiki 0.28
drug815 Cloth Face Mask Wiki 0.28
drug2766 RECHARGE Wiki 0.28
drug817 Co-mestring (co-coping) Wiki 0.28
drug825 Cognitive and behavioral intervention. Wiki 0.28
drug1717 Intralipid Wiki 0.28
drug811 Clofazimine Wiki 0.28
drug1182 Emotional Freedom Technique Wiki 0.28
drug2440 Patient management suffering of coronavirus infection Wiki 0.28
drug2746 Questionnaire forms Wiki 0.28
drug2932 Ruxolitinib 5 MG Wiki 0.28
drug1205 Enriched Survey Feedback Wiki 0.28
drug1408 Graded exercise test Wiki 0.28
drug3060 Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX] Wiki 0.28
drug2653 Problem-solving and relationship improvement intervention. Wiki 0.28
drug2681 Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout Wiki 0.28
drug2451 Peer Resilience Champion Wiki 0.28
drug816 Clungene rapid test cassette Wiki 0.28
drug1850 Local standard of care Wiki 0.28
drug1687 Interferon beta-1b Wiki 0.20
drug318 Assessment of work-related stress Wiki 0.20
drug3035 Saliva sample collection Wiki 0.20
drug730 Cardiac and electrodermal recordings Wiki 0.20
drug314 Assessment of behavioral response to emotional stimulation Wiki 0.20
drug803 Clinical assessment Wiki 0.20
drug4118 standard of care Wiki 0.16
drug4123 standard therapy Wiki 0.16
drug2254 Normal saline Wiki 0.12
drug3034 Saliva collection Wiki 0.11
drug798 Clazakizumab Wiki 0.11
drug2741 Questionnaire Wiki 0.10
drug2505 Placebo Wiki 0.03

Correlated MeSH Terms (6)


Name (Synonyms) Correlation
D002055 Burnout, Professional NIH 0.45
D007153 Immunologic Deficiency Syndromes NIH 0.11
D013315 Stress, Psychological NIH 0.11
Name (Synonyms) Correlation
D003863 Depression, NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.01
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002721 Immunodeficiency HPO 0.12

Clinical Trials

Navigate: Correlations   HPO

There are 13 clinical trials


1 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
2 Burnout and Medical Errors in the Anaesthesiology Fraternity in an Exclusively Covid-19 Hospital: the Malaysian Experience

We plan to perform an observational study to evaluate the prevalence of burnout, depression and medical errors in a designated exclusive Covid-19 patients hospital in Malaysia, during the Covid-19 pandemic. We also seek to assess the relationship between burnout and depression with medical errors. The population studied will be the anaesthesiology fraternity, who are at higher risk to the nature of their work at the frontlines of the pandemic.

NCT04362319
Conditions
  1. Burnout, Professional
  2. Depression
  3. Medical Errors
  4. Covid-19
Interventions
  1. Diagnostic Test: Questionnaire forms
MeSH:Burnout, Professional Burnout, Psychological

Primary Outcomes

Description: Assessment of burnout risk

Measure: Prevalence of burnout among anaesthesiology clinicians during Covid-19

Time: One month

Description: Assessment of depression risk

Measure: Prevalence of depression risk among anaesthesiology clinicians during Covid-19

Time: One month

Description: Assessment of medical errors

Measure: Prevalence of self-perceived medical errors among anaesthesiology clinicians during Covid-19

Time: One month

Description: To find out if there exists a relationship between burnout, depression and medical errors

Measure: Association of burnout, depression and medical errors among anaesthesiology clinicians during Covid-19

Time: One month
3 Exploring Provider Burnout During the COVID-19 Pandemic

Since the novel coronavirus, SARS-CoV-2, was first reported in the Hubei province of China in December 2019, the US has become an epicenter for the pandemic, accounting for more than 220,000 cases and 4,800 deaths (CDC). The rapid spread of the associated disease, COVID-19, has overwhelmed healthcare systems in spite of unprecedented measures to reduce contagion. The resulting uncertainty with regard to the duration and magnitude of the pandemic and limited availability of resources and treatment have been detrimental to the mental health of frontline healthcare providers (NIH). Preserving the psychological wellbeing of these individuals is paramount to mitigating the effect of COVID-19 and delivering optimal patient care. Of particularly grave concern is how professional and personal distress caused by the COVID-19 pandemic will affect provider burnout (Lai et al. JAMA Network Open 2020). Professional burnout, characterized by emotional exhaustion, career de-prioritization, and loss of self-efficacy, represents a significant threat to the US healthcare system (Shanafelt et al. Ann Surg 2010; Han et al. Annals of Internal Medicine 2019). While burnout has been described as a reaction to chronic work-related stress (Melamed et al. Psychol. Bull. 2006), individual factors such as anxiety increase susceptibility to burnout (Sun et al. J Occup Health 2012). Although data suggests that occupational stress might amplify risk of anxiety (DiGiacomo and Adamson J Allied Health 2001), we have yet to understand how intensified anxiety among frontline providers during global health crises contributes to burnout. Similarly, it is unknown whether factors such as perceived organizational support (POS), a key driver of job satisfaction and performance (Muse and Stamper, J Managerial Issues 2007), modify anxiety and burnout under these circumstances. We hypothesize that diminished POS in response to the COVID-19 pandemic is associated with burnout and that this relationship is mediated by an increase in providers' anxiety. Delineating this relationship is a critical first step in developing interventions that ease the mental health burden of this pandemic and future crises for healthcare providers.

NCT04370938
Conditions
  1. Perceived Organizational Support, Anxiety, Burnout
Interventions
  1. Behavioral: Coping strategies video
MeSH:Burnout, Psychological

Primary Outcomes

Description: As healthcare providers have limited time, it is unclear if this request to watch a 1 hour video on coping strategies will be a feasible intervention. We will assess how many individuals endorse actually watching this video.

Measure: Feasibility of undertaking task

Time: 6 months
4 Nursing Perspective on Burnout and Medical Errors in the Intensive Care Unit of an Exclusively Covid-19 Hospital: the Malaysian Experience

The investigators plan to perform an observational study to evaluate the prevalence of burnout, depression and medical errors in a designated exclusive Covid-19 patients hospital in Malaysia, during the Covid-19 pandemic. In addition, the relationship between burnout and depression with medical errors will be assessed. The population studied will be the nurses working in the Intensive Care Unit, who are at higher risk due to the nature of their work at the frontlines of the pandemic.

NCT04371302
Conditions
  1. Burnout, Professional
  2. Medical Errors
  3. Depression
Interventions
  1. Diagnostic Test: Questionnaire
MeSH:Burnout, Professional Depression Burnout, Psychological

Primary Outcomes

Description: Prevalence of burnout risk

Measure: Prevalence of burnout among ICU nurses during Covid-19

Time: 2 months

Description: Prevalence of depression risk

Measure: Prevalence of depression among ICU nurses during Covid-19

Time: 2 months

Description: Prevalence of self perceived medical errors

Measure: Prevalence of self-perceived medical errors among ICU nurses during Covid-19

Time: 2 months

Description: To find out if there exists a relationship between burnout, depression and medical errors

Measure: Association of burnout, depression and medical errors among anaesthesiology clinicians during Covid-19

Time: 2 months
5 Peer Champion Support for Hospital Staff During and After the COVID-19 Pandemic

Experience from the 2003 Severe Acute Respiratory Syndrome (SARS) outbreak taught that healthcare workers (HCWs) often experience chronic stress effects for months or years after such an event, and that supporting HCWs requires attention to the marathon of occupational stress, not just the sprint of dramatic stressors that occur while infections are dominating the news. This study will test if the well-being of hospital workers facing a novel coronavirus outbreak is improved by adding either of two interventions: (1) Peer Resilience Champions (PRC): an interdisciplinary team of professionals who actively monitor for early signs of heightened stress within clinical teams, liaise between staff and senior management to improve organizational responsiveness, and provide direct support and teaching (under the supervision of experts in resilience, infection control, and professional education). Investigators will test the effectiveness of this PRC Intervention by rolling it out to different parts of the hospital in stages and comparing levels of burnout before and after the intervention reaches particular teams and units (a stepped wedge design). By the end of the study, PRC Support will have been provided to all clinical and research staff and many learners (> 6,000 people). Note that the provision of PRC support will be directed to the entire organization. The research portion of the study is the evaluation of PRC support through a repeated survey completed by consenting staff. Investigators will test the effectiveness of the PRC by measuring trends in burnout and other effects of stress over the course of the study in a subgroup of hospital workers (as many as consent, target ~1000 people) through an online questionnaire (called "How Are You?"). (2) The second intervention is an enriched version of the "How Are You?" Survey, which provides personalized feedback about coping, interpersonal interactions and moral distress. Participants will be randomized (1:1) to receive the shorter Express Survey (identifying data and outcome measures only), or the Enriched survey (all of the Express measures plus additional measures with feedback based on responses). It is hypothesized that both the PRC intervention and the Enriched Survey intervention will help prevent or reduce instances of burnout in HCWs.

NCT04373382
Conditions
  1. Burnout
Interventions
  1. Behavioral: Peer Resilience Champion
  2. Behavioral: Enriched Survey Feedback
MeSH:Burnout, Psychological

Primary Outcomes

Description: Impact of the Peer Resilience Champion intervention as determined by a high outcome (defined as a cutoff of ≥27 on the Maslach Burnout Inventory: Emotional Exhaustion subscale)

Measure: Change in instances of burnout for hospital staff due to the Peer Resilience Champion intervention

Time: 21 months

Description: Impact of the Enriched survey feedback intervention as determined by a high outcome (defined as a cutoff of ≥27 on the Maslach Burnout Inventory: Emotional Exhaustion subscale)

Measure: Change in instances of burnout for hospital staff due to the Enriched Feedback Survey intervention

Time: 21 months
6 Emotional Freedom Technique (EFT) Effect on Nurses' Stress, Anxiety, and Burnout Levels: A Randomized Controlled Study

Background: Infectious disease outbreaks have a psychological effect on the general population, and especially on health workers. Nurses who care for COVID-19 patients feel negative emotions, fear, and anxiety due to fatigue, discomfort, and helplessness due to high-intensity work. Objective: The study aims to evaluate the effect of EFT in the prevention of stress, anxiety, and burnout of nurses who have an important position in the fight against COVID-19. Design: Randomized controlled trial. Setting: COVID-19 department of a university hospital in Istanbul Province, Turkey. Participants: The sample of the study consisted of nurses working on 80 COVID-19 cases. Methods: The investigators will recruit nurses who care for the patient infected with COVID-19 randomly allocated them to the intervention (n = 40) and control (n = 40) groups. EFT will apply to the experimental group with online access. Data will collect using the Introductory Characteristics Form, the Subjective Discomfort Unit Scale, the State-Trait Anxiety Inventory, and the Burnout Scale.

NCT04393077
Conditions
  1. Stress
  2. Anxiety
  3. Burnout, Caregiver
Interventions
  1. Behavioral: Emotional Freedom Technique
MeSH:Burnout, Psychological

Primary Outcomes

Description: The cognitive element of EFT involves self-rating of distress severity and pairing of an abbreviated exposure statement and a self-acceptance statement. The severity of distress was evaluated by subjects on an 11-point Likert scale. 0 corresponds to absolutely no distress, while 10 corresponds to the maximum possible distress. This was considered as the subjective units of distress scale (SUD) and provides clinicians and patients with the measurement of the severity of symptoms experienced by the latter in addition to a repeated measure by which the progress can be evaluated.

Measure: The subjective units of distress scale

Time: Immediately after EFT implementation

Description: The State-Trait Anxiety Inventory includes two separate scales with a total of 40 items. This study employed the State Anxiety Scale. Its validity and reliability in Turkish were confirmed by Öner and Lecompte. The scale consists of 20 questions and anxiety questions. To obtain the anxiety scale, to state how the person feels at any time and under any circumstances, answers were requested taking into account the feelings related to the situation.

Measure: The State Anxiety

Time: Immediately after EFT implementation

Description: The scale was created to measure the professional burnout levels of individuals. Adaptation studies in Turkish were carried out by Çapri in (2006) This 7-point Likert type scale consists of 21 items, scoring between 1 (never) and 7 (always), while 4 items (3, 6, 19, 20) of the scale are scored in reverse. While evaluating the scale scores, the increase in the score obtained indicates that burnout increases and the decrease in score indicates that burnout decreases.

Measure: Burnout

Time: Immediately after EFT implementation
7 Multi-Center Prospective Cohort Study: Impact of Burnout on Cardiovascular and Immune Biomarkers Among Frontline Healthcare Professionals During Covid-19 Pandemic in Abu Dhabi Emirate

The main objective of our project is to investigate the evolution of psychosocial, cardiovascular and immune markers in healthcare with different levels of exposure to the COVID-19 pandemic.

NCT04422418
Conditions
  1. Cardiovascular Risk Factor
  2. Burnout
  3. Immune Deficiency
MeSH:Immunologic Deficiency Syndromes Burnout, Psychological
HPO:Immunodeficiency

Primary Outcomes

Description: Burnout - through self-reported stress and burnout thoughts, beliefs, emotions, behavior related to Covid-19 using Maslach Burnout Inventory. Maslach Burnout Inventory - is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE), Depersonalization (DP), and low sense of Personal Accomplishment (PA). Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day.

Measure: Change from Baseline Burnout at 2-3 months and 6 months

Time: baseline, 2-3 months, 6 months

Description: Data is collected through wearable monitoring technology. Cardiovascular risk through monitoring of heart rate variability (HRV) markers. Changes of heart rate variability (HRV) reflecting cardiac autonomic dysfunction are associated with greater risks for cardiac morbidity and mortality.

Measure: Change from Baseline Cardiovascular Risk Cardiovascular Risk Through Heart Rate Variability Markers at 2-3 months and 6 months

Time: baseline, 2-3 months, 6 months

Description: Data is collected through wearable monitoring technology. Actigraphy data is collected in 1 min epochs using the zero-crossing modes.

Measure: Change from Baseline Through Actigraphy at 2-3 months and 6 months

Time: baseline, 2-3 months, 6 months

Description: Data is collected through wearable monitoring technology. Sleep efficiency is defined as the proportion of the estimated sleep periods spent asleep. Sleep latency is the length of time taken to fall asleep, calculated as the time between 'lights off' to the first period of 3 min of consecutive epochs scored as sleep.

Measure: Change from Baseline Through Sleep Quality at 2-3 months and 6 months

Time: baseline, 2-3 months, 6 months

Description: Cardiovascular risk through Fuster-BEWAT score. The Fuster-BEWAT score will be analyzed as a continuous variable with total score ranging from 0 to 15 points. Additionally, each component will be categorized as ideal (3) or nonideal (0 to 2), and participants will be classified as having poor, intermediate, or ideal cardiovascular health based on the total number of ideal components (0 to 1 = poor, 2 to 3 = intermediate, 4 to 5 = ideal) (Fernández-Alvira et al., 2017).

Measure: Change from Baseline Cardiovascular Risk Through Fuster-BEWAT score at 2-3 months and 6 months

Time: baseline, 2-3 months, 6 months

Description: Classification of the immune function will be screened.

Measure: Change from Baseline Immune Dysfunction at 2-3 months and 6 months

Time: baseline, 2-3 months, 6 months

Secondary Outcomes

Description: Submaximal field test and maximal oxygen consumption (VO2, mL/kg/min).

Measure: Change from Baseline Cardio-Respiratory Fitness at 2-3 months and 6 months

Time: baseline, 2-3 months, 6 months
8 COVID-19 - Implications on Surgeons' Burnout and Career Satisfaction

This is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. The survey will be conducted online through an online survey development cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the nature of the survey and informed that they will be listed as co-authors. Collected data will be confidential and anonymous. The first sector of the questionnaire includes trainee demographics and baseline characteristics. Then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice.

NCT04433286
Conditions
  1. Physical Stress
  2. Career Burnout
  3. Satisfaction
Interventions
  1. Other: Questionnaire
MeSH:Burnout, Professional Burnout, Psychological

Primary Outcomes

Description: A questionnaire designed based on the literature review to assess Burnout

Measure: Change in Burnout before COVID-19 and during COVID-19

Time: 1 year before COVID-19 versus during the COVID-19 pandemic (Mrach-June 2020)

Description: A questionnaire designed based on the literature review to assess Job satisfaction

Measure: Change in Job satisfaction before COVID-19 and during COVID-19

Time: 1 year before COVID-19 versus during the COVID-19 pandemic (Mrach-June 2020)
9 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
10 Parental Burnout During the COVID-19 Pandemic: Risk Factors and Predictors

The present study seeks to investigate the levels of parental burnout in the general parental population during the COVID-19 pandemic. Parental burnout is measured three months following (T2) the initiated viral mitigation protocols in Norway, a period where schools and kindergartens were closed, involving a period of home isolation for parents with their children. The burden of parents during this period is thought to have increased, as they were expected to conduct their own work virtually where possible, while at the same time acting as teachers for their children. The study aims to investigate the level of burnout among parents after months of viral mitigation strategies involved in the pandemic, in addition to predictors of parental burnout measured at (T1) are associated with parental burnout after three months (T2). Hypothesis and research question: Research Question 1: What is the level of parental burnout in the general parental population three months following initiated viral mitigation protocols (i.e., physical distancing) as compared to other similar pre-pandemic samples? Hypothesis 1: Parental burnout will be higher in the present sample three months into the pandemic as compared to similar pre-pandemic samples in similar populations. Hypothesis 2: Levels of parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, unhelpful coping strategies, marital quality and insomnia, all at T2 will significantly predict levels of parental burnout at T2. Exploratory: Do the predictors parental stress, parental satisfaction, general self-efficacy, positive metacognitions, negative metacognitions, unhelpful coping strategies, all at baseline (T1), predict parental burnout at T2, beyond and above these same aforementioned predictors at T2 and pre-existing mental health condition, age, gender, and education? Exploratory: Levels of parental burnout will be explored across subgroups in the sample.

NCT04442386
Conditions
  1. Parental Burnout
Interventions
  1. Other: Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout
MeSH:Burnout, Psychological

Primary Outcomes

Description: The Parental Burnout Inventory (PBI) (Roskam et al., 2017) consists of 22 items related to three divisions of parental burnout: Personal Accomplishment, Emotional Exhaustion and Emotional Distancing. The inventory is rated on a seven-point Likert-scale ranging from never (0) to every day (6). Higher scores indicate greater parental burnout severity, and scores above 88 are considered as the cut-off for parental burnout (Roskam et al., 2017).

Measure: The Parental Burnout Inventory (PBI)

Time: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks
11 The Role of Virtual Peer Support Platforms for Reducing Stress and Burnout Among Frontline Healthcare Workers During COVID-19: A Randomized Controlled Trial

Physician burnout has a significant impact on the wellness and productivity of physicians as well as patient health outcomes. Managing burnout among frontline workers is critical to Canada's response to the COVID-19 pandemic, in order to support frontline workers and reduce inefficiencies and medical errors frequently linked to burnout, ultimately improving our ability to detect, treat and manage COVID-19 cases. Therefore, this trial aims to assess the effects of an 8-session intervention over 3 months for burnout in physician residents in residency programs in Canada and the United States of America during the COVID-19 pandemic. This trial will provide evidence to inform health system management and public health response early and effectively so as to maintain the integrity of our workforce during and post-pandemic. The virtual delivery platform renders the proposed intervention easily disseminated internationally, in low- middle- and high- income countries and across urban and rural cities.

NCT04474080
Conditions
  1. Burnout
Interventions
  1. Behavioral: Virtual Peer Support Platform
  2. Behavioral: Control Period
MeSH:Burnout, Psychological

Primary Outcomes

Description: Maslach Burnout Inventory (MBI) will be administered to measure overall burnout. The MBI is a 22-item measure of the three dimensions of burnout: emotional exhaustion (EE), depersonalization (DP) and lack of personal accomplishment (PA) on a 7-point Likert scale ranging from 0 to 6. High scores on EE (≥26) or DP (≥9), and low scores on PA (≤34) are indicative of burnout.

Measure: Assess and measure overall burnout

Time: Change from baseline at month 3 and 6.

Secondary Outcomes

Description: Instrument/method of measurement: Stress will be measured using the Perceived Stress Scale, a 10-item scale ranging from 0-4 representing never to very often, with total scores between 0-40.

Measure: Assess stress

Time: Change from baseline at month 3 and 6.

Description: depression will be measured using a feasible two question approach developed by Spitzer et. al, validated by Whooley et. al.

Measure: Assess depression

Time: Change from baseline at month 3 and 6.

Description: Instrument/method of measurement: Single item linear analog scale. A score of 5 or less on this scale has known association with poor outcomes across clinical research of burnout.

Measure: Assess quality of life

Time: Change from baseline at month 3 and 6.
12 Impact of Perceived Control on Operational Strain: a Study of COVID-19 Pandemic Caregivers and Military Personnel on Operational Missions

Stress is underpinned by a biological reaction of the organism allowing the production of energy to respond to a change in the environment (or stressor). Stress reaction is expressed in behavioural, cognitive, emotional and physiological terms. This biological response is non-specific because it is the same regardless of the stressor. Its evolution over time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome (GAS) which comprises three successive phases. (i) The first phase, known as the alarm phase, corresponds to the activation of all biological mechanisms according to a trend regulation, allowing a rapid response to the stressor. (ii) The second phase of resistance which adjusts the stress response to the intensity of the perceived aggression according to a constant regulation. (iii) When the aggression disappears, a recovery phase dominated by the return of the parasympathetic brake allows a return to homeostasis (eustress). The "primum movens" of all pathologies is therefore the inability of the individual to adapt his stress response in duration and/or intensity to the course of the phases of the GAS (distress). The perception of not being in control of the situation contributes to the perceived stress and constitutes a well-established risk of distress. It is a risk factor for the emergence of burnout. It induces a biological cost called allostatic cost. Allostasis is a concept that characterizes the process of restoring homeostasis in the presence of a physiological challenge. The term "allostasis" means "achieving stability through change", and refers in part to the process of increasing sympathetic activity and corticotropic axis to promote adaptation and restore homeostasis. Allostasis works well when allostasis systems are initiated when needed and turned off when they are no longer required. Restoring homeostasis involves effective functioning of the parasympathetic system. However, when the allostasis systems remain active, such as during chronic stress, they can cause tissue burnout and accelerate pathophysiological processes. The perception of uncontrollability depends on the stress situation, the psychological and physiological characteristics of the subject and his or her technical skills in responding to the stressors of the situation. In particular, subjects with a high level of mindfulness are more accepting of uncontrollability and less likely to activate the stress response. The COVID-19 pandemic situation is a situation characterized by many uncertainties about the individual, family and work environment and the risk of COVID infection. Healthcare workers, like the military, are high-risk occupations that are particularly exposed to these uncertainties in the course of their work and continue to work in an uncertain situation. These professionals are described as a population at risk of occupational/operational burnout that the level of burnout operationalises. This ancillary study in a population of civilian and military non-healthcare workers will complement the study conducted among military health care workers. It will make it possible to isolate the specificity of each profession (civilian or military, healthcare personnel or not) with regard to the risk of burnout in the COVID context. The objective of this project is to evaluate the impact of the perception of non-control in the operational burnout of experts in their field of practice and to study the psychological and physiological mechanisms mediating the relationship between the subject's characteristics, perceived non-control and burnout.

NCT04517136
Conditions
  1. Covid19
  2. SARS-CoV Infection
  3. Burnout, Caregiver
  4. Burnout, Professional
Interventions
  1. Behavioral: Assessment of work-related stress
  2. Biological: Saliva sample collection
  3. Device: Cardiac and electrodermal recordings
  4. Behavioral: Assessment of behavioral response to emotional stimulation
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Burnout, Professional Burnout, Psychological

Primary Outcomes

Description: Professional burnout is measured at D21 by the Burnout Measure Short Version (BMS) questionnaire It is a 10-item questionnaire used to assess burnout regardless of the occupational category. Each item is rated from 0 to 6 ("never" to "always"). An average score (sum/10) below 2.4 indicates a very low degree of burnout exposure; a score between 2.5 and 3.4 indicates a low degree of burnout exposure; a score between 3.5 and 4.4 indicates the presence of burnout; a score between 4.5 and 5.4 indicates a high degree of burnout exposure; a score above 5.5 indicates a very high degree of burnout exposure.

Measure: Professional burnout

Time: 21 days after enrollment (Day 21)

Description: Mindfulness level is assessed at D0 thanks to the Freiburg Mindfulness Inventory. It is a 14 item scale. Each item is rated from 1 to 4 ("almost never" to "almost always"). The total score is between 14 and 56. The mean value in a population of young adults under 36 years of age is 38.5 (+/- 5.1 standard deviation).

Measure: Mindfulness level

Time: Day 1

Secondary Outcomes

Description: Perceived stress level is assessed with the Perceived Stress Scale (PSS). It is a 14 item scale. Each item is rated from 0 to 5 ("never" to "very often"). The total score ranges from 0 to 56 with higher scores indicating greater perceived stress.

Measure: Perceived stress level following the emotional stimulation

Time: Day 1

Description: Parasympathetic flexibility is assessed through dynamic electro-physiological analysis of cardiac and electrodermal conductance recordings. Physiological and cognitive reserve of emotional regulation is assessed through the analysis of the spectral power of the 0.1 Hz frequency band at emotional recall.

Measure: Parasympathetic flexibility evolution during emotional recall

Time: Day 1

Description: The activity of the sympathetic tone is assessed by the measurement of the resting state salivary Chromogranin A. Physiological and cognitive reserve of emotional regulation is assessed through the analysis of the spectral power of the 0.1 Hz frequency band at emotional recall. The activity of the sympathetic tone is assessed by the measurement of the resting salivary Chromogranin A

Measure: Sympathetic tone at rest

Time: Day 1

Description: Corticotropic activation at rest is assessed through the DHEA/cortisol level ratio

Measure: Corticotropic activation at rest

Time: Day 1

Description: The Hospital Anxiety and Depression Scale (HAD-s32) is used to assess mood disorders in the general non-psychiatric population. It is used to discriminate between anxiety and depression. Scores greater than 11 are indicative of characterized anxiety/depression.

Measure: Mood disorders (anxiety / depression)

Time: Day 1

Description: Post-traumatic disorder is assessed with the PTSD Checklist (PCL-5). It is a 20-item self-administered questionnaire representing Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Post-traumatic stress disorder (PTSD) diagnosis symptoms rated by the subject on a scale from 0 ("not at all") to 4 ("extremely") during the past month. Scores range from 0 to 80. A score greater than of 33 evokes the presence of post-traumatic stress disorder.

Measure: Post-traumatic stress disorder

Time: Day 1

Description: Sleep quality is assesses thanks to the Leeds Sleep Evaluation questionnaire (LEEDS). It consists of ten visual analogue scales assessing four aspects of sleep: (i) quality of falling asleep and degree of drowsiness, (ii) quality of sleep, (iii) quality of wakefulness, and (iv) quality of post-wakefulness and performance.

Measure: Sleep quality

Time: Day 1
13 RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19

The healthcare industry is inherently demanding, stressful, and, at times, emotionally draining. On a typical day, many workers must make rapid and critical decisions, manage numerous demands, team conflicts, and challenging situations with patients and their families. For some health care workers (HCW), the current pandemic - COVID-19 - has also exacerbated these challenges. Providing psychological support is key in alleviating stress among HCWs, yet the situation does not require therapy because HCWs do not principally suffer from a mental disorder. RECHARGE was specifically developed for HCWs and is an abbreviated online version of Problem Management Plus, an evidence-based intervention that helps to cope with stress in times of crisis. As a brief psychological intervention for adults affected by adversity emerging from stress exposure, RECHARGE teaches people three well-documented strategies to manage acute stress (a: managing stress, b: managing worry, c: meaningful activity). It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioral activation, and enhancement of meaningful activities, which are all based on the principles of cognitive-behavioral therapy. The aim of this study is to evaluate the efficacy of RECHARGE to reduce stress in HCWs and enhance their work performance. Participants in this randomized controlled trial (RCT) study are randomly assigned to either RECHARGE or the active control group. To this end, stress including symptoms of burnout, worries, anxiety, depression, PTSD, and work performance will be measured at baseline, post-intervention, and at a 2 and 6 month follow up.

NCT04531774
Conditions
  1. Stress
  2. Burnout
  3. Anxiety
  4. Depression
  5. Covid19
Interventions
  1. Behavioral: RECHARGE
  2. Behavioral: Self Study
MeSH:Depression Burnout, Psychological

Primary Outcomes

Description: HCWs in the intervention condition (RECHARGE) demonstrate a lower level of distress after the intervention and at 2-month follow-up than HCWs in the active control condition.

Measure: Change from Baseline in psychological distress Kessler Psychological Distress Scale (K10) at Week 5 and Week 13

Time: Baseline (Week 1), post-intervention (Week 5) and 2 month follow-up (Week 13)

Secondary Outcomes

Description: HCWs in the intervention condition demonstrate fewer worries after the intervention and at 2-month follow-up than HCWs in the active control condition. Worries are measured using the Generalized Anxiety Disorder Assessment (GAD-7)

Measure: Fewer worries in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate less anxiety after the intervention and at 2-month follow-up than HCWs in the active control condition. Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS).

Measure: Less anxiety symptoms in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate fewer symptoms of depression after the intervention and at 2-month follow-up than HCWs in the active control condition. Depression is measured using the Hospital Anxiety and Depression Scale (HADS).

Measure: Fewer depression symptoms in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate a lower level of burnout after the intervention and at 2-month follow-up than HCWs in the active control condition. Burnout is measured using the Maslach Burnout Inventory (MBI).

Measure: Lower level of burnout in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate less traumatic stress after the intervention and at 2-month follow-up than HCWs in the active control condition. Traumatic stress is measured using the PTSD Checklist (PCL-5).

Measure: Less traumatic stress in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate a lower level of distress due to perceived moral injury after the intervention and at 2-month follow-up than HCWs in the active control condition. Distress due to perceived moral injury is measured using Moral Injury Appraisals (MI).

Measure: Lower level of distress due to perceived moral injury in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

Description: HCWs in the intervention condition demonstrate a higher work performance after the intervention and at 2-month follow-up than HCWs in the active control condition. Work performance is measured using the Work Ability Index (WAI).

Measure: Higher work performance in intervention group than in active control group

Time: post-intervention (Week 5) and 2 month follow-up (Week 13)

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on September 26, 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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