Heart Rate VariabilityHOPENCT06532305
Helping Overcome Pressure and Exhaustion: Empowerment Classes for Southeast Asian Migrant Care Workers
A study testing HOPE empowerment classes in people with Heart Rate Variability and Burnout, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
As Taiwan's population ages, Southeast Asian migrant care workers are widely employed to fill the care labor gap. These workers often face symptoms of burnout and emotional stress due to long working hours and high-pressure environments. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability, Burnout, Depression
- What is being tested?
- HOPE empowerment classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jul 2024to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indonesian migrant care workers responsible for caring for patients in homes or care institutions.
- Aged 18 years or older.
Who cannot join
- Individuals unable to read the informed consent form or questionnaires in Indonesian.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Psychiatry, National Taiwan University Hospital
Taipei, 1002
I-Ming Chen, MD, PhD, 886-2-23123456 ext. 267991, iming@ntuh.gov.tw
I-Ming Chen, MD, PhD
About this study
Official title: The Effects of Empowerment Classes on Burnout Syndrome and Emotional Stress Among Southeast Asian Migrant Care Workers: A Randomized Crossover Study
As Taiwan's population ages, Southeast Asian migrant care workers are widely employed to fill the care labor gap. These workers often face symptoms of burnout and emotional stress due to long working hours and high-pressure environments. This study aims to evaluate the effects of empowerment classes on reducing burnout symptoms and emotional stress among Southeast Asian migrant care workers. The empowerment classes are designed based on expert consensus and cover three core areas: mental health and stress management, dementia care skills, and language and communication skills. The curriculum is tailored to the practical needs and cultural backgrounds of the migrant workers. A total of 120 Indonesian care workers will be randomly assigned to two groups. The first group will undergo a three-month empowerment course, while the second group will initially participate in social gatherings. Afterward, the groups will switch interventions. The study will last for 12 months, and each participant will complete seven assessments, including heart rate variability measurements and online questionnaires. The questionnaires will include the Patient Health Questionnaire-2 (PHQ-2), the Copenhagen Burnout Inventory (CBI), the Life and Cultural Adaptation Questionnaire, and the Language Proficiency Questionnaire. The study anticipates that the empowerment classes will reduce burnout symptoms and emotional stress, while enhancing cultural adaptation and language proficiency among migrant care workers.
Read the detailed description
Study Design:
The study employs a randomized crossover design involving 120 Indonesian care workers in Taiwan. Participants will be randomly assigned to two groups. The first group will undergo a three-month empowerment course initially, while the second group will participate in social gatherings. After three months, the interventions will be switched between the groups. The empowerment classes will cover three core areas: mental health and stress management, dementia care skills, and language and communication skills, tailored to the workers' practical needs and cultural backgrounds.
Duration:
The study will last for 12 months, starting from July 26, 2024, to July 25, 2025.
Data Collection:
Participants will complete seven assessments, including heart rate variability measurements and online questionnaires. The questionnaires will include the Patient Health Questionnaire-2 (PHQ-2), the Copenhagen Burnout Inventory (CBI), the Life and Cultural Adaptation Questionnaire, and the Language Proficiency Questionnaire.
Expected Outcomes:
The study anticipates that the empowerment classes will reduce burnout symptoms and emotional stress, while enhancing cultural adaptation and language proficiency among migrant care workers.
Ethical Considerations:
Participation in this study is voluntary, and participants can withdraw at any time without negative consequences. All personal data will be kept confidential and used solely for research purposes.
- Conditions
- Heart Rate Variability, Burnout, Depression
- Being tested
- HOPE empowerment classes
- Keywords
- empowerment, burnout, dementia, migrant care worker
- Medical subject headings
- Burnout, Psychological, Depression, Empowerment, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPE empowerment classesBehavioural
A three-month empowerment course.
| Study group | Role | What they receive |
|---|---|---|
| Empowerment classes | Experimental | Content:
Mental Health and Stress Management: Techniques and strategies for managing stress, mindfulness practices, and mental health awareness.
Dementia Care Skills: Training on dementia care, communication with dementia patients, and specific caregiving techniques.
Language and Communication Skills: Improving proficiency in local languages and enhancing communication skills relevant to caregiving.
Follow-up: After completing the empowerment classes, participants will switch to the social gatherings intervention. Receives: Behavioral: HOPE empowerment classes |
| Social gatherings | Active comparator | Content:
Social Interaction: Regular gatherings to promote social bonding and peer support among care workers.
Recreational Activities: Group activities designed to foster relaxation and social engagement.
Informal Discussions: Opportunities for care workers to share experiences and coping strategies in an informal setting.
Follow-up: After completing the social gatherings, participants will switch to the empowerment classes intervention. Receives: Behavioral: HOPE empowerment classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout levels
Measured using the Copenhagen Burnout Inventory (CBI). The primary outcome will be the change in burnout levels from baseline to the end of each intervention period. Burnout will be assessed in three domains: personal burnout, work-related burnout, and client-related burnout. Higher scores on the CBI indicate a higher level of burnout, meaning worse outcomes in terms of burnout severity. The range of CBI is 0-100.
Measured: 12 months
Emotional Stress
Measured using the Patient Health Questionnaire-2 (PHQ-2). The outcome will be the change in emotional stress levels from baseline to the end of each intervention period. A PHQ-2 score ranges from 0-6. Higher scores on the PHQ-2 indicate greater severity of depressive symptoms, meaning worse outcomes in terms of emotional stress.
Measured: 12 months
Heart Rate Variability
Heart Rate Variability measurements will be used to assess changes in autonomic nervous system function, providing an objective measure of stress levels.
Measured: 12 months
Secondary outcomes (2)
Cultural Adaptation
Measured using the Life and Cultural Adaptation Questionnaire. The secondary outcome will be the change in cultural adaptation levels from baseline to the end of each intervention period. There is a total of 11 questions that inquire about the respondent's adaptation to daily life, work, and culture in Taiwan. Its total score ranges from 11-66. Each item is rated on a scale of 1 to 6, with higher scores indicating better adaptation.
Measured: 12 months
Language Proficiency
Assessed using the Language Proficiency Questionnaire. The secondary outcome will be the change in language proficiency levels from baseline to the end of each intervention period. There is a total of 7 questions primarily aimed at understanding the current usage of Mandarin and Taiwanese. Each item is rated on a scale of 1 to 6, with higher scores indicating better communication skills in the respective language. The total score ranges from 7 to 42.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start26 Jul 2024 (estimated)
- Primary completion25 Jul 2025 (estimated)
- Study completion25 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532305
- Sponsor's protocol ID
- 202406135RINE
- Acronym
- HOPE
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Empowerment Classes on Burnout Syndrome and Emotional Stress Among Southeast Asian Migrant Care Workers: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT06532305
- Acronym / sponsor ID
- HOPE / 202406135RINE
- Conditions
- Heart Rate Variability, Burnout, Depression
- Keywords
- empowerment, burnout, dementia, migrant care worker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 Jul 2024 (estimated)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 25 Jul 2025 (estimated)
- First posted
- 1 Aug 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.
As Taiwan's population ages, Southeast Asian migrant care workers are widely employed to fill the care labor gap. These workers often face symptoms of burnout and emotional stress due to long working hours and high-pressure environments. This study aims to evaluate the effects of empowerment classes on reducing burnout symptoms and emotional stress among Southeast Asian migrant care workers. The empowerment classes are designed based on expert consensus and cover three core areas: mental health and stress management, dementia care skills, and language and communication skills. The curriculum is tailored to the practical needs and cultural backgrounds of the migrant workers. A total of 120 Indonesian care workers will be randomly assigned to two groups. The first group will undergo a three-month empowerment course, while the second group will initially participate in social gatherings. Afterward, the groups will switch interventions. The study will last for 12 months, and each participant will complete seven assessments, including heart rate variability measurements and online questionnaires. The questionnaires will include the Patient Health Questionnaire-2 (PHQ-2), the Copenhagen Burnout Inventory (CBI), the Life and Cultural Adaptation Questionnaire, and the Language Proficiency Questionnaire. The study anticipates that the empowerment classes will reduce burnout symptoms and emotional stress, while enhancing cultural adaptation and language proficiency among migrant care workers.
Detailed description
Study Design:
The study employs a randomized crossover design involving 120 Indonesian care workers in Taiwan. Participants will be randomly assigned to two groups. The first group will undergo a three-month empowerment course initially, while the second group will participate in social gatherings. After three months, the interventions will be switched between the groups. The empowerment classes will cover three core areas: mental health and stress management, dementia care skills, and language and communication skills, tailored to the workers' practical needs and cultural backgrounds.
Duration:
The study will last for 12 months, starting from July 26, 2024, to July 25, 2025.
Data Collection:
Participants will complete seven assessments, including heart rate variability measurements and online questionnaires. The questionnaires will include the Patient Health Questionnaire-2 (PHQ-2), the Copenhagen Burnout Inventory (CBI), the Life and Cultural Adaptation Questionnaire, and the Language Proficiency Questionnaire.
Expected Outcomes:
The study anticipates that the empowerment classes will reduce burnout symptoms and emotional stress, while enhancing cultural adaptation and language proficiency among migrant care workers.
Ethical Considerations:
Participation in this study is voluntary, and participants can withdraw at any time without negative consequences. All personal data will be kept confidential and used solely for research purposes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empowerment classes | Experimental | Behavioral: HOPE empowerment classesContent: Mental Health and Stress Management: Techniques and strategies for managing stress, mindfulness practices, and mental health awareness. Dementia Care Skills: Training on dementia care, communication with dementia patients, and specific caregiving techniques. Language and Communication Skills: Improving proficiency in local languages and enhancing communication skills relevant to caregiving. Follow-up: After completing the empowerment classes, participants will switch to the social gatherings intervention. |
| Social gatherings | Active comparator | Behavioral: HOPE empowerment classesContent: Social Interaction: Regular gatherings to promote social bonding and peer support among care workers. Recreational Activities: Group activities designed to foster relaxation and social engagement. Informal Discussions: Opportunities for care workers to share experiences and coping strategies in an informal setting. Follow-up: After completing the social gatherings, participants will switch to the empowerment classes intervention. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indonesian migrant care workers responsible for caring for patients in homes or care institutions.
- Aged 18 years or older.
Key exclusion criteria (1 listed)
- Individuals unable to read the informed consent form or questionnaires in Indonesian.
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 |
|---|---|---|
| HOPE empowerment classesA three-month empowerment course. | Behavioural | Empowerment classes, Social gatherings |
Primary outcome
Burnout levels
Time frame: 12 months
Measured using the Copenhagen Burnout Inventory (CBI). The primary outcome will be the change in burnout levels from baseline to the end of each intervention period. Burnout will be assessed in three domains: personal burnout, work-related burnout, and client-related burnout. Higher scores on the CBI indicate a higher level of burnout, meaning worse outcomes in terms of burnout severity. The range of CBI is 0-100.
Emotional Stress
Time frame: 12 months
Measured using the Patient Health Questionnaire-2 (PHQ-2). The outcome will be the change in emotional stress levels from baseline to the end of each intervention period. A PHQ-2 score ranges from 0-6. Higher scores on the PHQ-2 indicate greater severity of depressive symptoms, meaning worse outcomes in terms of emotional stress.
Heart Rate Variability
Time frame: 12 months
Heart Rate Variability measurements will be used to assess changes in autonomic nervous system function, providing an objective measure of stress levels.
2 secondary outcomes
Cultural Adaptation
Time frame: 12 months
Language Proficiency
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Department of Psychiatry, National Taiwan University Hospital
Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOPE empowerment classes in people with Heart Rate Variability and Burnout, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Aug 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
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?
Burnout levels (time frame: 12 months). The study lists 3 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 6 Aug 2024.