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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04504877
Recruitment Status : Active, not recruiting
First Posted : August 7, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Jose Alexandre de Souza Crippa, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Covid19 Burn Out Post Traumatic Stress Disorder Drug: Cannabidiol Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling (Bonsai Study) wIth COVID-19: a Randomised Controlled Trial
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : November 16, 2020
Estimated Study Completion Date : December 16, 2020

Resource links provided by the National Library of Medicine


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 Name: general clinical supportive measures

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 Name: general clinical supportive measures




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


Secondary Outcome Measures :
  1. Brief measure for assessing generalized anxiety disorder: The GAD-7 [ Time Frame: Through study completion, over time during the study period (day 0-28) ]
    brief measure for assessing generalized anxiety disorder

  2. PHQ-9: Patient´s Health Questionnaire-9 [ Time Frame: Through study completion, over time during the study period (day 0-28) ]
    Evaluate depressive symptoms o

  3. Change in proinflammatory cytokine concentration [ Time Frame: Through study completion, over time during the study period (day 0-28) ]
    Laboratory parameters, including the change in proinflammatory cytokine concentrations

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Through study completion, over time during the study period (day 0-28) ]
    Occurrence of side effects

  5. Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [ Time Frame: Through study completion, over time during the study period (day 0-28) ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   24 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504877


Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, SP, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Jose A. Crippa, MD; PhD University of Sao Paulo
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Responsible Party: Jose Alexandre de Souza Crippa, Full Professor - Psychiatry, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04504877    
Other Study ID Numbers: BONSAI Study
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Epidiolex
Anticonvulsants