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

NCT06617247 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 79253324.5.0000.5440
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

cannabidiol; caregivers; empathy; Burnout syndrome

Outcome Measures

Primary Outcomes (4)

• Interpersonal Reactivity Index - IRI

  IRIis a self-assessment instrument, developed for the purpose of multidimensional empathy evaluation, and will be used the version adapted and translated into Brazilian Portuguese. The Brazilian version of IRI evaluates dimensions (i.e., perspective taking, empathic consideration and personal anguish) and is composed by 21 questions (seven items to evaluate cognitive domain and 14 for evaluation of affective domain) with answers from one (low empathy) to five (high empathy) and the higher your score, the higher the level of empathy.

  From enrollment to the end of treatment at 4 weeks

• Multifaceted Empathy Test - MET

  The MET is a computerized instrument that allows to evaluate separately the affective and cognitive domains of empathy. The application of this instrument is performed on a computer and consists of photographs that depict people in different emotional situations (i.e., positive and negative). To assess cognitive empathy, subjects must infer the mental states of individuals shown in the images by selecting one of four descriptors of mental state (e.g., proud, joy, happy, relieved). To assess affective empathy, subjects evaluate their level of empathic concern for the individuals shown in the images on a likert scale from 1 (no little) to 9 (extremely) points. The translated version will be used and adapted to the Brazilian context.

  From enrollment to the end of treatment at 4 weeks

• Kliniske Undersøgelser Side Effect Rating Scale - UKU-SERS

  The safety and tolerability of the use of cannabidiol will be evaluated by UKU-SERS. Developed to evaluate the side effects and psychodrugs of the clinical research committee of the Scandinavian society of psychopharmacology. It is a self-applicable instrument that evaluates the severity of symptoms and perception of side effects in relation to four dimensions (i.e., psychiatric, neurological, autonomic and others) in 48 items with a likert response ranging from 0 to 3 and a total score ranging from 0 to 144. Acceptance will be evaluated by the percentage of participants who dropped out for other reasons not related to tolerability. This instrument in particular, will be applied by means of connection (i.e., weekly) and assisted at the end of the intervention, given a possible difficulty in understanding technical terms, the researcher will read, explain the criterion and score the instrument together with volunteer. This instrument will be used as a primary

  From enrollment to the end of treatment at 4 weeks

• Maslach's Burnout Inventory - MBI

  The objective of the scale is to evaluate the presence of Burnout Syndrome as a consequence of overload caused by chronic stress factors experienced in the work environment. This is an inventory that evaluates three main dimensions (emotional exhaustion, depersonalization and professional achievement) composed of 9 items scored on a likert scale: for each of the questions are assigned increasing intensity degree 0 (never) to 6 (daily). The translated and validated version for the Brazilian context was performed and this will be used in this study. The following scores were adopted for each subscale: emotional exhaustion 9; depersonalization 6 and; professional achievement 10.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (4)

• Questionnaire of assistance offered - QAO

  From enrollment to the end of treatment at 4 weeks

• Neuropsychiatric Inventory - NPI

  From enrollment to the end of treatment at 4 weeks

• Impact of possible side effects associated with CBD use

  From enrollment to the end of treatment at 4 weeks

• Global Clinical Printing - CGI

  From enrollment to the end of treatment at 4 weeks

Other Outcomes (3)

• Patient Health Questionnaire - PHQ-9

  From enrollment to the end of treatment at 4 weeks

• Independence Scale in Daily Life Activities - ESDLA

  From enrollment to the end of treatment at 4 weeks

• Sociodemographic and care questionnaire

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Intervention 2: Placebo

EXPERIMENTAL

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

Drug: Intervention 2: Placebo

Intervention1: Cannabidiol

EXPERIMENTAL

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).

Drug: Intervention1: Cannabidiol

Interventions

Intervention1: Cannabidiol 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).

Intervention1: Cannabidiol

Intervention 2: Placebo 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 (

Intervention 2: Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University os São Paulo

Ribeirão Preto, São Paulo, Brazil

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Randomized, parallel, double-blind, placebo-controlled two-arm clinical trial to achieve the main objective of the study.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)