Burnout SyndromeEarly Phase 1NCT06617247
Effects of Cannabidiol on Burnout Syndrome and Empathy of Caregivers of Older Adults
A Early Phase 1 study testing Intervention1: Cannabidiol in people with Burnout Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Burnout Syndrome
- What is being tested?
- Intervention1: Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2024to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
University os São Paulo
Ribeirão Preto, São Paulo
Madson A Maximiano-Barreto, PhD, 55 16 98252-918, mmaximianopsi@gmail.com
About this study
Official title: Effects of Cannabidiol on Burnout Syndrome and Empathy of Paid and Unpaid Caregivers of Older Adults
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
- Being tested
- Intervention1: Cannabidiol, Intervention 2: Placebo
- Keywords
- cannabidiol, caregivers, empathy, Burnout syndrome
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention1: CannabidiolDrug
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 2: PlaceboDrug
In this group, the subjects will receive placebo intervention. For blinding purposes, caregivers in this group will use the vehicle of oral CBD 300mg (
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Drug: Intervention1: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (4)
Questionnaire of assistance offered - QAO
An instrument developed by researchers to evaluate the assistance provided by caregivers of elderly people. It consists of 10 items, scored on a likert scale (0 (very dissatisfied) to 4 (very satisfied)), to be answered by the caregiver. The score of this instrument will have a range between 0 and 40 and the higher the score, the better the assistance provided to the person receiving care (i.e., elderly).
Measured: From enrollment to the end of treatment at 4 weeks
Neuropsychiatric Inventory - NPI
The NPI is an inventory developed that aims to evaluate the frequency and severity of neuropsychiatric symptoms. This instrument presents scores for the severity of symptoms ranging from 1 to 3 (1 = mild; 2 = moderate; 3 = severe) and frequency from 0 to 4 (0 = not disturbing; 5 = extreme). It is a likert type instrument composed of 12 items where its total score (sum of the frequency x intensity of the items) varies from 0 to 120 points. The translated version will be used and adapted to Brazilian Portuguese. This instrument is applied to the caregiver and evaluates neuropsychiatric symptoms of care recipients and will be a secondary outcome of the study, with the objective of evaluating the impact of the intervention on care recipients (i.e., older people). This instrument will be evaluated before and after the intervention in Phase 2.
Measured: From enrollment to the end of treatment at 4 weeks
Impact of possible side effects associated with CBD use
This questionnaire was developed with the objective of evaluating the impact of some possible side effects associated with the use of CBD in the provision of care to the elderly. The study that evaluated the effect of CBD on Burnout syndrome in health professionals who worked on the front line of COVID-19, which identified the following side effects: fatigue, increased appetite, weight gain, diarrhea and lethargy, effects also observed in other studies. Therefore, this questionnaire was included in the study using adapted questions of specific measures for headache (HIT-6 TM), sleep (PSQI-BR), gastrointestinal symptoms (GSRS) and lightheadedness (DHI). The questionnaire is composed of six questions scored on a dichotomous scale (Yes/No).
Measured: From enrollment to the end of treatment at 4 weeks
Global Clinical Printing - CGI
The CGI is a simple and fast application instrument, validated for the Brazilian context, used to evaluate the severity of symptoms and response to treatment in patients with mental disorders (e.g., depression). This instrument is used in naturalistic studies and clinical practice. It is a scale of three items evaluated by the observer, which evaluates five dimensions (i.e., positive, negative, cognitive, depressive and global symptoms) in a score ranging from 1 (normal) to 7 (highest level of severity). CGI has proven to be a robust measure of efficacy in many clinical trials of drugs and is easy and quick to administer.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel, double-blind, placebo-controlled two-arm clinical trial to achieve the main objective of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madson Alan Maximiano-Barreto, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617247
- Sponsor's protocol ID
- 79253324.5.0000.5440
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Following ethical recommendations and guaranteed the security of anonymity of IPD.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabidiol on Burnout Syndrome and Empathy of Paid and Unpaid Caregivers of Older Adults
- ClinicalTrials.gov ID
- NCT06617247
- Acronym / sponsor ID
- 79253324.5.0000.5440
- Conditions
- Burnout Syndrome
- Keywords
- cannabidiol, caregivers, empathy, Burnout syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel, double-blind, placebo-controlled two-arm clinical trial to achieve the main objective of the study.
| Arm | Type | Receives |
|---|---|---|
| Intervention 2: Placebo | Experimental | Drug: Intervention 2: PlaceboIn 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 |
| Intervention1: Cannabidiol | Experimental | Drug: Intervention1: CannabidiolThe 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention1: CannabidiolOs 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). | Drug | Intervention1: Cannabidiol |
| Intervention 2: PlaceboIn this group, the subjects will receive placebo intervention. For blinding purposes, caregivers in this group will use the vehicle of oral CBD 300mg ( | Drug | Intervention 2: Placebo |
Primary outcome
Interpersonal Reactivity Index - IRI
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Questionnaire of assistance offered - QAO
Time frame: From enrollment to the end of treatment at 4 weeks
Neuropsychiatric Inventory - NPI
Time frame: From enrollment to the end of treatment at 4 weeks
Impact of possible side effects associated with CBD use
Time frame: From enrollment to the end of treatment at 4 weeks
Global Clinical Printing - CGI
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No. Following ethical recommendations and guaranteed the security of anonymity of IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intervention1: Cannabidiol in people with Burnout Syndrome, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interpersonal Reactivity Index - IRI (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.