Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling wIth COVID-19

Study Overview
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Brief Summary
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The objective of this work is to monitor the level of stress and overload of a group of front-line health workers (physicians, nurses and physiotherapists) who will participate in the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its Emergency Unit (HCRP), for four weeks, and evaluate the cannabidiol - CBD's effectiveness in reducing stress for those who wish to use it.

Detailed Description
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The Bonsai study is a two-arm, parallel-group, individually randomized (1:1 allocation ratio), controlled with general measures (supporting motivational videos, fitness videos), participant and investigator unblinded, evaluator by phone will be blinded, single-site superiority trial of oral CBD 300 mg daily for 28 days to prevent burnout and distress in health care workers dealing with SARS-CoV-2 exposure. At 28 days, there is an open-label extension wherein all participants are offered a 28 days course of CBD 300mg daily. The objective of this work is to monitor the level of stress and overload of a group of front-line health workers (physicians, nurses and physiotherapists) who will participate in the care of patients with COVID-19 at Hospital das Clínicas in Ribeirão Preto and its Emergency Unit (HCRP), for four weeks, and evaluate the CBD's effectiveness in reducing stress for those who wish to use it. This research intends to : Assess the level of stress and emotional overload of front-line health workers (physicians, nurses and physiotherapists) during their performance in the pandemic caused by COVID-19. Assess whether the daily use of CBD 300 mg, for four weeks, reduces the level of stress, during the period of performance of professionals in the care of patients with COVID-19. Assess whether the daily use of CBD 300 mg, for four weeks, will modify inflammatory parameters, such as cytokines, measured from the serum of professionals in the care of patients with COVID-19. Assess whether the daily use of CBD 300 mg, for four weeks, prevents depression, burnout and Acute Stress Disorder and PTSD. Assess the possible adverse effects of using CBD

Official Title
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Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling (Bonsai Study) wIth COVID-19: a Randomised Controlled Trial

Conditions
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Covid19, Burn Out, Post Traumatic Stress Disorder

Intervention / Treatment
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* Drug: Cannabidiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 24 and 60 years old Research participants of both sexes. HCFMRP physicians, nurses and physiotherapists involved in the care of patients who have undergone screening and present at least one symptom, which may be related to infection by COVID-19. Good health conditions and without conditions that characterize them as belonging to the risk groups associated with COVID infection19. Research participants with the potential to become pregnant may be included in the study as long as they are sexually abstinent or using a contraceptive method considered effective. Signature of the Free and Informed Consent Term approved (ICF) by the Research Ethics Committee (CEP) and CONEP. Exclusion Criteria: Using any medication with potential interaction with CBD or with a history of undesirable reactions prior to the use of this cannabinoid. Physicians, nurses and physiotherapists with occasional contact with patients with COVID-19 and who are not responsible for the continuous monitoring of these patients. Although in the HC-FMRP-USP care allocation policy, professionals who are eventually more susceptible to complications from the new coronavirus will be relocated to not attend patients with COVID19, it will be checked again to exclude patients with chronic diseases: diabetes, hypertension, lung disease like asthma or COPD; hematological diseases, chronic kidney disease and immunodepression. Professionals over 60 years old Female research participants who become pregnant or male participants who have their pregnant partner during the research project

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cannabidiol plus general clinical supportive measures<br>The participants will receive CBD 300mg/daily plus general measures (supporting motivational videos, fitness videos). All the participants will perform invasive and non-invasive procedures with the nursing team, the invasive being five blood collections, in their workplaces, to evaluate laboratory parameters, detailed in this project. The non-invasive ones refer to the measurement of height, weight, body temperature, and sleep pattern, as well as five collections of saliva, in a collecting tube, to assess viral load. They will also be monitored through weekly self-assessment scales, applied remotely, electronically (cell phones or computers), with an estimated duration of ten minutes each, which will have their responses recorded in an electronic database by the study coordination team. | Drug: Cannabidiol<br>* Cannabidiol 300 mg daily for 4 weeks<br>* Other names: general clinical supportive measures;|
| Other: general clinical supportive measures<br>The participants will receive general measures (supporting motivational videos, fitness videos) alone. All the participants will perform invasive and non-invasive procedures with the nursing team, the invasive being five blood collections, in their workplaces, to evaluate laboratory parameters, detailed in this project. The non-invasive ones refer to the measurement of height, weight, body temperature, and sleep pattern in a collecting tube to assess viral load. Also, they will be monitored through weekly self-assessment scales, applied remotely, electronically (cell phones or computers), with an estimated duration of ten minutes each, which will have their responses recorded in an electronic database by the study coordination team. | Drug: Cannabidiol<br>* Cannabidiol 300 mg daily for 4 weeks<br>* Other names: general clinical supportive measures;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aMBI-HSS: Abbreviated Maslach Burnout Inventory - Human Services Survey | To assess the emotional exhaustion dimension of the burnout syndrome, based on nine items, scored from 0 (never) to 6 (every day) | Through study completion, over time during the study period (day 0-28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief measure for assessing generalized anxiety disorder: The GAD-7 | brief measure for assessing generalized anxiety disorder | Through study completion, over time during the study period (day 0-28) | 
| PHQ-9: Patient´s Health Questionnaire-9 | Evaluate depressive symptoms o | Through study completion, over time during the study period (day 0-28) | 
| Change in proinflammatory cytokine concentration | Laboratory parameters, including the change in proinflammatory cytokine concentrations | Through study completion, over time during the study period (day 0-28) | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Occurrence of side effects | Through study completion, over time during the study period (day 0-28) | 
| Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) | It is a self-report measure widely used to assess PTSD symptoms, according to the DSM-5 criteria. The reduced version of this instrument will be used (8 items) | Through study completion, over time during the study period (day 0-28) |