Clinical trial NCT06617247: Effects of Cannabidiol on Burnout Syndrome and Empathy of Caregivers of Older Adults
Official title: Effects of Cannabidiol on Burnout Syndrome and Empathy of Paid and Unpaid Caregivers of Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Burnout Syndrome
Keywords: cannabidiol
caregivers
empathy
Burnout syndrome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel, double-blind, placebo-controlled two-arm clinical trial to achieve the main objective of the study.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Interpersonal Reactivity Index - IRI
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Multifaceted Empathy Test - MET
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Kliniske Undersøgelser Side Effect Rating Scale - UKU-SERS
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Maslach's Burnout Inventory - MBI
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Questionnaire of assistance offered - QAO
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Neuropsychiatric Inventory - NPI
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Impact of possible side effects associated with CBD use
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Global Clinical Printing - CGI
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
measure: Patient Health Questionnaire - PHQ-9
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Independence Scale in Daily Life Activities - ESDLA
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Sociodemographic and care questionnaire
timeFrame: From enrollment to the end of treatment at 4 weeks
Locations:
city: Ribeirão Preto
country: Brazil
facility: University os São Paulo
state: São Paulo
Study officials:
References: