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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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 fo
• Препарат 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 (

Первичные конечные точки

• Interpersonal Reactivity Index - IRI [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Multifaceted Empathy Test - MET [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Kliniske Undersøgelser Side Effect Rating Scale - UKU-SERS [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Maslach's Burnout Inventory - MBI [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Вторичные конечные точки (4)

• Questionnaire of assistance offered - QAO [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Neuropsychiatric Inventory - NPI [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Impact of possible side effects associated with CBD use [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Global Clinical Printing - CGI [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• University os São Paulo — Ribeirão Preto

Идентификаторы

NCT: NCT06617247 · 79253324.5.0000.5440

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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