Covid19Phase 2/3BONSAINCT04504877
Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling wIth COVID-19
A Phase 2/3 study testing Cannabidiol in people with Covid19 and Burn Out, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Burn Out, Post Traumatic Stress Disorder
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Jun 2020to 16 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: 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.
Read the 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 :
- 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.
- 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.
- 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.
- Assess whether the daily use of CBD 300 mg, for four weeks, prevents depression, burnout and Acute Stress Disorder and PTSD.
- Assess the possible adverse effects of using CBD
- Conditions
- Covid19, Burn Out, Post Traumatic Stress Disorder
- Being tested
- Cannabidiol
- Medical subject headings
- COVID-19, Burnout, Psychological, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called general clinical supportive measures
Cannabidiol 300 mg daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 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
brief measure for assessing generalized anxiety disorder
Measured: Through study completion, over time during the study period (day 0-28)
PHQ-9: Patient´s Health Questionnaire-9
Evaluate depressive symptoms o
Measured: 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
Measured: 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
Measured: 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)
Measured: Through study completion, over time during the study period (day 0-28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start16 Jun 2020
- Primary completion16 Nov 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Alexandre S Crippa, University of Sao Paulo
- Investigators
- Jose A. Crippa, MD; PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504877
- Sponsor's protocol ID
- BONSAI Study
- Acronym
- BONSAI
- Status last verified
- Sep 2021
- First submitted
- 4 Aug 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification
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.
PubMed 34387679
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burnout and Distress preventiOn With caNnabidiol in Front-line Health Care workerS deAling (Bonsai Study) wIth COVID-19: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04504877
- Acronym / sponsor ID
- BONSAI / BONSAI Study
- Conditions
- Covid19, Burn Out, Post Traumatic Stress Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
- 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.
- 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.
- Assess whether the daily use of CBD 300 mg, for four weeks, prevents depression, burnout and Acute Stress Disorder and PTSD.
- Assess the possible adverse effects of using CBD
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cannabidiol plus general clinical supportive measures | Experimental | Drug: CannabidiolThe 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. |
| general clinical supportive measures | Other | Drug: CannabidiolThe 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. |
Who may qualify
- Ages
- 24 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: general clinical supportive measuresCannabidiol 300 mg daily for 4 weeks | Drug | cannabidiol plus general clinical supportive measures, general clinical supportive measures |
Primary outcome
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")
5 secondary outcomes
Brief measure for assessing generalized anxiety disorder: The GAD-7
Time frame: Through study completion, over time during the study period (day 0-28)
PHQ-9: Patient´s Health Questionnaire-9
Time frame: Through study completion, over time during the study period (day 0-28)
Change in proinflammatory cytokine concentration
Time frame: 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
Time frame: Through study completion, over time during the study period (day 0-28)
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: Through study completion, over time during the study period (day 0-28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 34387679Crippa 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A. Crippa, MD; PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cannabidiol in people with Covid19 and Burn Out, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aMBI-HSS: Abbreviated Maslach Burnout Inventory - Human Services Survey (time frame: Through study completion, over time during the study period (day 0-28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04504877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.