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

NCT ID: NCT04504877

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2020-12-16

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

Conditions

Covid19; Burn Out; Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Cannabidiol 300 mg daily for 4 weeks

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.

Group Type: OTHER

Cannabidiol

Intervention Type: DRUG

Cannabidiol 300 mg daily for 4 weeks

Interventions

Cannabidiol

Cannabidiol 300 mg daily for 4 weeks

Intervention Type: DRUG

Other Intervention Names

general clinical supportive measures

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Jose Alexandre S Crippa

Full Professor - Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose A. Crippa, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 34387679 (View on PubMed)

Other Identifiers

BONSAI Study

Identifier Type: -

Identifier Source: org_study_id