Effects of Cannabidiol on Burnout Syndrome and Empathy of Paid and Unpaid Caregivers of Older Adults
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Interpersonal Reactivity Index - IRI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Interpersonal Reactivity Index - IRI
时间窗: From enrollment to the end of treatment at 4 weeks
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.
Multifaceted Empathy Test - MET
时间窗: From enrollment to the end of treatment at 4 weeks
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.
Kliniske Undersøgelser Side Effect Rating Scale - UKU-SERS
时间窗: From enrollment to the end of treatment at 4 weeks
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
Maslach's Burnout Inventory - MBI
时间窗: From enrollment to the end of treatment at 4 weeks
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.
次要结局
- 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)
研究者
Madson Alan Maximiano-Barreto
PhD
University of Sao Paulo