NCT06532305

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

August 6, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

July 29, 2024

Last Update Submit

August 4, 2024

Conditions

Keywords

empowermentburnoutdementiamigrant care worker

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    12 months

Secondary Outcomes (2)

  • Cultural Adaptation

    12 months

  • Language Proficiency

    12 months

Study Arms (2)

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.

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.

Behavioral: HOPE empowerment classes

Interventions

A three-month empowerment course.

Empowerment classesSocial gatherings

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indonesian migrant care workers responsible for caring for patients in homes or care institutions.
  • Aged 18 years or older.

You may not qualify if:

  • Individuals unable to read the informed consent form or questionnaires in Indonesian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, National Taiwan University Hospital

Taipei, 1002, Taiwan

Location

MeSH Terms

Conditions

Burnout, PsychologicalDepressionEmpowermentDementia

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorSocial BehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 1, 2024

Study Start

July 26, 2024

Primary Completion

July 25, 2025

Study Completion

July 25, 2025

Last Updated

August 6, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations