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

National Health Research Institutes, Taiwan

Status: Completed

Conditions: Caregivers Burnout; Burnout, Professional; Stress, Psychological; Caregivers

Treatments: Behavioral: Mindfulness-Based Digital Intervention (AIZEN Program)

Study type: Interventional

Funder types: Other

Identifiers

NCT07188454

EC1110102-R4

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• 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

• Did not meet the definition of caregiver (professional or informal)
• Prior meditation practice within the three months before recruitment
• Unwilling or unable to provide written informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Immediate Meditation Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Digital Intervention (AIZEN Program)

Wait-list Control

No Intervention group

Description:

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.