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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Post Traumatic Stress Disorder; Burn Out
• Intervention / Treatment: Drug: Cannabidiol

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Ribeirão Preto, SP, Brazil, 14048-900
      • Hospital Das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cannabidiol plus general clinical supportive measures; 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; Cannabidiol 300 mg daily for 4 weeks; Other Names: general clinical supportive measures
Other: general clinical supportive measures; 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; Cannabidiol 300 mg daily for 4 weeks; Other Names: general clinical supportive measures

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Jose A. Crippa, MD; PhD, University of São Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): November 16, 2020
• Study Completion (Actual): December 16, 2020

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Trauma and Stressor Related Disorders; COVID-19; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: BONSAI Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification
• IPD Sharing Time Frame: Immediately the following publication. No end date
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Depending on the level of the proposed use of data, approval by an independent review committee will be required for the identified purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No