Abstract
Frontline health care professionals who work with patients with COVID-19 have an increased incidence of burnout symptoms. Cannabidiol (CBD) has anxiolytic and antidepressant properties and may be capable of reducing emotional exhaustion and burnout symptoms. To investigate the safety and efficacy of CBD therapy for the reduction of emotional exhaustion and burnout symptoms among frontline health care professionals working with patients with COVID-19. This prospective open-label single-site randomized clinical trial used a 1:1 block randomization design to examine emotional exhaustion and burnout symptoms among frontline health care professionals (physicians, nurses, and physical therapists) working with patients with COVID-19 at the Ribeirão Preto Medical School University Hospital in São Paulo, Brazil. Participants were enrolled between June 12 and November 12, 2020. A total of 214 health care professionals were recruited and assessed for eligibility, and 120 participants were randomized in a 1:1 ratio by a researcher who was not directly involved with data collection. Cannabidiol, 300 mg (150 mg twice per day), plus standard care or standard care alone for 28 days. The primary outcome was emotional exhaustion and burnout symptoms, which were assessed for 28 days using the emotional exhaustion subscale of the Brazilian version of the Maslach Burnout Inventory-Human Services Survey for Medical Personnel. A total of 120 participants were randomized to receive either CBD, 300 mg, plus standard care (treatment arm; n = 61) or standard care alone (control arm; n = 59) for 28 days. Of those, 118 participants (59 participants in each arm; 79 women [66.9%]; mean age, 33.6 years [95% CI, 32.3-34.9 years]) received the intervention and were included in the efficacy analysis. In the treatment arm, scores on the emotional exhaustion subscale of the Maslach Burnout Inventory significantly decreased at day 14 (mean difference, 4.14 points; 95% CI, 1.47-6.80 points; partial eta squared [ηp2] = 0.08), day 21 (mean difference, 4.34 points; 95% CI, 0.94-7.73 points; ηp2 = 0.05), and day 28 (mean difference, 4.01 points; 95% CI, 0.43-7.59 points; ηp2 = 0.04). However, 5 participants, all of whom were in the treatment group, experienced serious adverse events: 4 cases of elevated liver enzymes (1 critical and 3 mild, with the mild elevations reported at the final 28-day assessment) and 1 case of severe pharmacodermia. In 2 of those cases (1 with critical elevation of liver enzymes and 1 with severe pharmacodermia), CBD therapy was discontinued, and the participants had a full recovery. In this study, CBD therapy reduced symptoms of burnout and emotional exhaustion among health care professionals working with patients during the COVID-19 pandemic. However, it is necessary to balance the benefits of CBD therapy with potential undesired or adverse effects. Future double-blind placebo-controlled clinical trials are needed to confirm the present findings. ClinicalTrials.gov Identifier: NCT04504877.
Highlights
During the COVID-19 pandemic, most countries adopted lockdown and physical distancing measures as containment strategies
Design The Burnout and Distress Prevention With Cannabidiol in Front-line Health Care Workers Dealing With COVID-19 (BONSAI) study was a single-site 2-arm parallel-group randomized clinical trial designed to assess whether the efficacy and safety of oral CBD, 300 mg, plus standard care administered daily for 28 days was superior to standard care alone for the prevention or reduction of emotional exhaustion and burnout symptoms among health care professionals working with patients with COVID-19
Statistical Analysis Because no previous studies had examined the effects of CBD therapy on the reduction of emotional exhaustion among frontline health care professionals working with patients with COVID-19, we calculated sample size by estimating a significance level of α = .05, a statistical power of 0.8, and an effect size (Cohen f) of 0.10, resulting in a sample of 114 participants
Summary
During the COVID-19 pandemic, most countries adopted lockdown and physical distancing measures as containment strategies. This situation led to severe social and economic consequences and affected mental health.[1,2,3,4] Several surveys have reported pandemic-related increases in emotional distress, depression,[3,5] anxiety,[3,5] posttraumatic stress disorder (PTSD),[3,4,5,6] and insomnia,[6] among frontline health care workers.[2] The usual pharmacological treatments for these conditions (antidepressant, anxiolytic, and hypnotic medications) often require several weeks to be effective and can produce substantial adverse effects (AEs). Cannabidiol been found to have antidepressant[12,13,14] and antiinflammatory[15,16,17,18,19,20,21] effects in preclinical studies
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