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

NCT ID: NCT06617247

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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 (150mg twice

Group Type: EXPERIMENTAL

Intervention 2: Placebo

Intervention Type: DRUG

In this group, the subjects will receive placebo intervention. For blinding purposes, caregivers in this group will use the vehicle of oral CBD 300mg (

Intervention1: Cannabidiol

The caregivers randomized for this intervention will use oral CBD 300 mg (i.e., 150mg, twice daily) for four weeks. The substance will be provided free of charge by the company Ease Labs, and will be administered in capsules to promote blinding. This posology was based on the study, in which CBD in this dosage and form of presentation proved to be safe and effective in reducing indicators of burnout in frontline health professionals from COVID-19. The safety of CBD use has also been reported in previous studies conducted with humans. Side effects from CBD use are rare, including mild and tolerable symptoms (e.g., dizziness, drowsiness, fatigue, lethargy, nausea, headache, fever, and sensory changes).

Group Type: EXPERIMENTAL

Intervention1: Cannabidiol

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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 (

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Total score 4 in the IEAVD
• Score on the emotional exhaustion subscale of MBI 9 and/or depersonalization 6 and/or; professional achievement 10
• Low level of empathy in the EMRI scale (i.e., total score 71)
• In addition, they should have a score of 10 on the PHQ-9, indicating absence of expressive depressive symptoms

Exclusion Criteria

• Not have the availability to participate in this phase of the research will be excluded
• Who have ceased to exercise the position of carer of a person aged 60 years or more
• Who no longer perform minimum workload of six hours daily and
• Not complete the protocol of the intervention received.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Madson Alan Maximiano-Barreto

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University os São Paulo

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Facility Contacts

Madson A Maximiano-Barreto, PhD

Role: primary

mmaximianopsi@gmail.com

55 16 98252-918

Other Identifiers

79253324.5.0000.5440

Identifier Type: -

Identifier Source: org_study_id