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

NCT04504877 | Completed Phase 2 DMC

• 1 other identifier: BONSAI Study
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Burn Out; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Brief measure for assessing generalized anxiety disorder: The GAD-7

  Through study completion, over time during the study period (day 0-28)

• PHQ-9: Patient´s Health Questionnaire-9

  Through study completion, over time during the study period (day 0-28)

• Change in proinflammatory cytokine concentration

  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

  Through study completion, over time during the study period (day 0-28)

• Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  Through study completion, over time during the study period (day 0-28)

Study Arms (2)

cannabidiol plus general clinical supportive measures

EXPERIMENTAL

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

general clinical supportive measures

OTHER

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

Interventions

Cannabidiol DRUG

Cannabidiol 300 mg daily for 4 weeks

Also known as: general clinical supportive measures

cannabidiol plus general clinical supportive measures; general clinical supportive measures

Eligibility Criteria

• Age: 24 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 34387679 DERIVED

MeSH Terms

Conditions

COVID-19; Burnout, Psychological; Stress Disorders, Post-Traumatic

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Jose A. Crippa, MD; PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Volunteers, administrative staff, laboratory technicians, doctors who will carry out the assessments by phone, and statisticians will be blind to the treatment group and will not know about the group treatment information.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor - Psychiatry

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: June 16, 2020
• Primary Completion: November 16, 2020
• Study Completion: December 16, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately the following publication. No end date
• 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.

Locations

BR (1)