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

NCT07188454 | Completed

• 1 other identifier: EC1110102-R4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Burnout, Professional; Caregivers; Caregivers Burnout; Stress, Psychological

Keywords

Meditation; Mindfulness; Digital health intervention; Caregiver burnout; Caregiver burden; Professional caregivers; Family caregivers; Stress reduction; Mental health; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Change in Personal Burnout (Copenhagen Burnout Inventory, Professional Caregivers)

  Personal burnout was measured using the Chinese version of the Copenhagen Burnout Inventory (CBI). This subscale includes 5 items that assess general physical and psychological exhaustion. Each item is scored on a 5-point scale (0 = "never" to 100 = "always"), and the subscale score is calculated as the mean of all items, with higher scores indicating greater burnout.

  Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)

• Change in Work-Related Burnout (Copenhagen Burnout Inventory, Professional Caregivers)

  Work-related burnout was measured using the Chinese version of the Copenhagen Burnout Inventory (CBI). This subscale consists of 5 items that assess exhaustion specifically attributed to work demands. Each item is scored on a 5-point scale (0 = "never" to 100 = "always"), and the subscale score is calculated as the mean of all items, with higher scores indicating greater burnout.

  Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)

• Change in Client-Related Burnout (Copenhagen Burnout Inventory, Professional Caregivers)

  Client-related burnout was measured using the Chinese version of the Copenhagen Burnout Inventory (CBI). This subscale consists of 6 items that assess exhaustion specifically attributed to interactions with care recipients or clients. Each item is scored on a 5-point scale (0 = "never" to 100 = "always"), and the subscale score is calculated as the mean of all items, with higher scores indicating greater burnout.

  Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)

Secondary Outcomes (1)

• Change in Caregiver Burden (Zarit Burden Interview, Informal Caregivers)

  Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)

Study Arms (2)

Immediate Meditation Intervention

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Digital Intervention (AIZEN Program)

Wait-list Control

NO INTERVENTION

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.

Interventions

Mindfulness-Based Digital Intervention (AIZEN Program) BEHAVIORAL

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.

Immediate Meditation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (1)

National Health Research Institutes

Zhunan, Taiwan

Location

MeSH Terms

Conditions

Burnout, Professional; Stress, Psychological; Caregiver Burden; Psychological Well-Being

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: May 1, 2025
• Primary Completion: September 13, 2025
• Study Completion: September 13, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)