NCT06617247

Effects of Cannabidiol on Burnout Syndrome and Empathy of Caregivers of Older Adults

Effects of Cannabidiol on Burnout Syndrome and Empathy of Paid and Unpaid Caregivers of Older Adults

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Burnout syndrome is an occupational disease that has affected health care providers, for example, caregivers of older adults. This syndrome negatively affects physical and psychological health, which may reflect on the mental health of the caregiver and the care provided to the older adults. Interventions have been developed to minimize the impacts of burnout. Thus, this study has two main objectives: 1) to identify the effect of cannabidiol on indicators of burnout and empathy of caregivers of older people with functional dependence for activities of daily living; 2) identify possible associations between burnout indicators, empathy levels and their domains, and quality of care. This is a two-phase study (i.e., Phase 1: cross-sectional; Phase 2: clinical trial). In Phase 1, caregivers will answer questionnaires developed by researchers for sociodemographic characterization, care and satisfaction of care. In addition, they will complete instruments to assess the functional dependence of the older people - EIAVD, depressive symptoms - PHQ-9, social support - EAS, Burnout syndrome - MBI and Empathy - EMRI and MET. In Phase 2, caregivers will be randomized to cannabidiol or placebo intervention. Caregivers with number 0 will be allocated to the intervention using cannabidiol (300mg - divided into two times a day) and those drawn with number 1 will be allocated to the placebo group. Both interventions will be performed for four weeks. Caregivers will fill in the MBI, EMRI, MET, NPI and QAO instruments before and after the intervention. UKU-SERS will also be applied to evaluate side effects, IECC to assess the impact of intervention on care and CGI to assess severity and response to treatment.

Conditions

• Burnout Syndrome

Interventions

Type	Name	Description
DRUG	Intervention1: Cannabidiol	Os cuidadores randomizados para esta intervenção usarão CBD oral 300 mg (ou seja, 150 mg, duas vezes ao dia) por quatro semanas. A substância será fornecida gratuitamente pela empresa Ease Labs e será administrada em cápsulas para promover o cegamento. Esta posologia foi baseada no estudo, no qual o CBD nesta dosagem e forma de apresentação provou ser seguro e eficaz na redução de indicadores de burnout em profissionais de saúde da linha de frente da COVID-19. A segurança do uso do CBD também foi relatada em estudos anteriores conduzidos com humanos. Os efeitos colaterais do uso do CBD são raros, incluindo sintomas leves e toleráveis (por exemplo, tontura, sonolência, fadiga, letargia, náusea, dor de cabeça, febre e alterações sensoriais).
DRUG	Intervention 2: Placebo	In this group, the subjects will receive placebo intervention. For blinding purposes, caregivers in this group will use the vehicle of oral CBD 300mg (

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2024-09-27
• Last updated: 2024-10-01

Locations

1 site across 1 country: Brazil