Clinical trial NCT04504877: Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling wIth COVID-19
Official title: Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling (Bonsai Study) wIth COVID-19: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Covid19
Burn Out
Post Traumatic Stress Disorder
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 120
Sex: ALL
Minimum age (years): 24
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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 :

1. 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.
2. 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.
3. 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.
4. Assess whether the daily use of CBD 300 mg, for four weeks, prevents depression, burnout and Acute Stress Disorder and PTSD.
5. Assess the possible adverse effects of using CBD

Eligibility criteria: Inclusion Criteria:

1. age between 24 and 60 years old
2. Research participants of both sexes.
3. 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.
4. Good health conditions and without conditions that characterize them as belonging to the risk groups associated with COVID infection19.
5. 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.
6. Signature of the Free and Informed Consent Term approved (ICF) by the Research Ethics Committee (CEP) and CONEP.

Exclusion Criteria:

1. Using any medication with potential interaction with CBD or with a history of undesirable reactions prior to the use of this cannabinoid.
2. Physicians, nurses and physiotherapists with occasional contact with patients with COVID-19 and who are not responsible for the continuous monitoring of these patients.
3. 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.
4. Professionals over 60 years old
5. Female research participants who become pregnant or male participants who have their pregnant partner during the research project

Primary outcomes:
measure: aMBI-HSS: Abbreviated Maslach Burnout Inventory - Human Services Survey
timeFrame: Through study completion, over time during the study period (day 0-28)
Secondary outcomes:
measure: Brief measure for assessing generalized anxiety disorder: The GAD-7
timeFrame: Through study completion, over time during the study period (day 0-28)
measure: PHQ-9: Patient´s Health Questionnaire-9
timeFrame: Through study completion, over time during the study period (day 0-28)
measure: Change in proinflammatory cytokine concentration
timeFrame: Through study completion, over time during the study period (day 0-28)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Through study completion, over time during the study period (day 0-28)
measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: Through study completion, over time during the study period (day 0-28)
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Jose A. Crippa, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crippa JAS, Zuardi AW, Guimaraes FS, Campos AC, de Lima Osorio F, Loureiro SR, Dos Santos RG, Souza JDS, Ushirohira JM, Pacheco JC, Ferreira RR, Mancini Costa KC, Scomparin DS, Scarante FF, Pires-Dos-Santos I, Mechoulam R, Kapczinski F, Fonseca BAL, Esposito DLA, Pereira-Lima K, Sen S, Andraus MH, Hallak JEC; Burnout and Distress Prevention With Cannabidiol in Front-line Health Care Workers Dealing With COVID-19 (BONSAI) Trial Investigators. Efficacy and Safety of Cannabidiol Plus Standard Care vs Standard Care Alone for the Treatment of Emotional Exhaustion and Burnout Among Frontline Health Care Workers During the COVID-19 Pandemic: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2120603. doi: 10.1001/jamanetworkopen.2021.20603.