An interventional study of HOPE empowerment classes in Heart Rate Variability, Burnout and Depression, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Prevention
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.
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.
458 studies on the registry are indexed under Burnout, Psychological; 110 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 331 interventional studies indexed under Burnout, Psychological.
Browse Burnout, Psychological studies →National Taiwan University Hospital is the lead sponsor of 2,608 studies on the registry; 573 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
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.
Behavioral: HOPE empowerment classes
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.
Behavioral: HOPE empowerment classes
A three-month empowerment course.
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Jul 2025, 11 months later.
Of 248 non-industry interventional studies with no phase under Burnout, Psychological, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 11 months is close to that.
Counting every sponsor, half of 255 studies reached it within 11 months; a quarter within 5 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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