NCT07188454

The Effects of a Meditation Intervention on the Psychological Burden of Long-Term Care Professionals and Family Caregivers

Intervention Programs and Outcomes for Managing Behavioral Problems in Dementia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn whether a brief, digitally-supported mindfulness program can reduce caregiver burnout in professional caregivers (such as nurses, case managers, and care workers) and informal family caregivers in Taiwan. 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).

Detailed description

This study was a randomized, stratified, wait-list-controlled pilot clinical trial conducted in Taiwan to evaluate the feasibility and preliminary efficacy of a digitally-supported mindfulness program for caregivers. 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

• Burnout, Professional
• Caregivers
• Caregivers Burnout
• Stress, Psychological

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-09-13
• Completion: 2025-09-13
• First posted: 2025-09-23
• Last updated: 2025-09-23

Locations

1 site across 1 country: Taiwan