The Effects of a Meditation Intervention on the Psychological Burden of Long-Term Care Professionals and Family Caregivers
NCT ID: NCT07188454
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2025-05-01
2025-09-13
Brief Summary
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The main questions it aims to answer are:
Does the mindfulness program reduce personal and work-related burnout among professional caregivers?
Does the mindfulness program reduce caregiver burden among informal family caregivers?
Researchers compared an immediate-intervention group with a wait-list control group to see if those who received the program earlier experienced greater improvements.
Participants were asked to:
Join five weekly 90-minute live online classes led by an instructor.
Practice daily 10-minute guided mindfulness sessions using the AIZEN digital platform.
Complete questionnaires about stress and caregiver burden at three time points: baseline (T1), after the 5-week program (T2), and 5-week follow-up (T3).
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Detailed Description
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Participants were randomized 1:1 to either:
Immediate-intervention group (received the 5-week program immediately after randomization), or
Wait-list control group (received the same program after completing their post-intervention assessment at 5 weeks).
Participants were stratified by caregiver type (professional vs. informal), age (younger vs. older than the sample median), and perceived stress level (low vs. high). Randomization was computer-generated and implemented independently of outcome assessment.
The intervention was a 5-week program consisting of:
Weekly 90-minute live, instructor-led sessions delivered via Microsoft Teams.
Daily home practice supported by guided meditation audio tracks on the AIZEN digital platform.
Automated daily reminders through the LINE messaging service to encourage adherence.
Outcome assessments were collected at three time points:
T1 (Baseline, Week 0) - prior to randomization
T2 (Post-intervention, Week 5) - after completion of the immediate group's program
T3 (Follow-up, Week 10) - after the wait-list group completed the program
The primary outcomes were changes in burnout among professional caregivers, assessed with the Chinese version of the Copenhagen Burnout Inventory (CBI), including personal, work-related, and client-related dimensions. A secondary exploratory outcome was caregiver burden among informal caregivers, assessed with the Zarit Burden Interview (ZBI).
Statistical analyses used linear mixed-effects models with planned contrasts to evaluate three core hypotheses:
Primary intervention effect: whether changes from T1 to T2 differed between groups (difference-in-differences).
Replication effect: whether the wait-list group showed improvements after receiving the program (T2 to T3).
Maintenance effect: whether benefits for the immediate-intervention group were sustained at follow-up (T2 to T3).
In addition, exploratory analyses included adjustment for work over-commitment as a covariate and evaluation of whether daily home practice (logged via the AIZEN platform) mediated intervention effects.
This study was designed as a feasibility and proof-of-concept trial to inform the scalability of digital mindfulness interventions for caregivers in Taiwan.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Immediate Meditation Intervention
Participants received a 5-week digitally supported mindfulness program immediately after randomization. The program included five weekly 90-minute live online classes led by an instructor and daily guided mindfulness practice (about 10 minutes per day) using the AIZEN digital platform, with automated reminders delivered via the LINE messaging service.
Mindfulness-Based Digital Intervention (AIZEN Program)
The intervention consisted of a 5-week mindfulness program designed for caregivers. Participants attended one live, instructor-led online class each week (90 minutes per session) delivered via Microsoft Teams. Between classes, they were asked to complete at least 10 minutes of daily guided mindfulness practice using the AIZEN digital platform. To encourage adherence, participants also received automated daily reminders through the LINE messaging service.
Wait-list Control
Participants were assigned to a wait-list control condition and did not receive the intervention during the first 5 weeks after randomization. After completing post-intervention assessments at Week 5, they received the identical 5-week mindfulness program, consisting of weekly 90-minute live online classes and daily guided mindfulness practice with the AIZEN platform.
No interventions assigned to this group
Interventions
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Mindfulness-Based Digital Intervention (AIZEN Program)
The intervention consisted of a 5-week mindfulness program designed for caregivers. Participants attended one live, instructor-led online class each week (90 minutes per session) delivered via Microsoft Teams. Between classes, they were asked to complete at least 10 minutes of daily guided mindfulness practice using the AIZEN digital platform. To encourage adherence, participants also received automated daily reminders through the LINE messaging service.
Eligibility Criteria
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Inclusion Criteria
* Currently engaged in paid professional caregiving (e.g., nurse, care worker, case manager) or unpaid informal/family caregiving
* Able to attend weekly online sessions via Microsoft Teams
* Willing to complete web-based questionnaires
* Willing to undertake at least 10 minutes of daily mindfulness practice
* No prior meditation experience within the three months preceding recruitment
Exclusion Criteria
* Prior meditation practice within the three months before recruitment
* Unwilling or unable to provide written informed consent
18 Years
ALL
No
Sponsors
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National Health Research Institutes, Taiwan
OTHER
Responsible Party
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Locations
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National Health Research Institutes
Zhunan, , Taiwan
Countries
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Other Identifiers
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EC1110102-R4
Identifier Type: -
Identifier Source: org_study_id
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