Burnout, ProfessionalNCT07188454
The Effects of a Meditation Intervention on the Psychological Burden of Long-Term Care Professionals and Family Caregivers
A study testing Mindfulness-Based Digital Intervention (AIZEN Program) in people with Burnout, Professional and Caregivers, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Professional, Caregivers, Caregivers Burnout
- What is being tested?
- Mindfulness-Based Digital Intervention (AIZEN Program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2025to 13 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Intervention Programs and Outcomes for Managing Behavioral Problems in Dementia
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:
Read more
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).
Read the 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.
- Being tested
- Mindfulness-Based Digital Intervention (AIZEN Program)
- Keywords
- Meditation, Mindfulness, Digital health intervention, Caregiver burnout, Caregiver burden, Professional caregivers, Family caregivers, Stress reduction, Mental health, Randomized controlled trial
- Medical subject headings
- Burnout, Professional, Stress, Psychological, Caregiver Burden, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Digital Intervention (AIZEN Program)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)
Secondary outcomes (1)
Change in Caregiver Burden (Zarit Burden Interview, Informal Caregivers)
Caregiver burden was measured using the Chinese version of the Zarit Burden Interview (ZBI). This validated instrument consists of 22 items that assess the impact of caregiving on the caregiver's emotional, social, and physical well-being. Each item is rated on a 5-point scale (0 = "never" to 4 = "nearly always"), with total scores ranging from 0 to 88. Higher scores indicate greater caregiver burden.
Measured: Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 May 2025
- Primary completion13 Sep 2025
- Study completion13 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188454
- Sponsor's protocol ID
- EC1110102-R4
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Programs and Outcomes for Managing Behavioral Problems in Dementia
- ClinicalTrials.gov ID
- NCT07188454
- Acronym / sponsor ID
- EC1110102-R4
- Keywords
- Meditation, Mindfulness, Digital health intervention, Caregiver burnout, Caregiver burden, Professional caregivers, Family caregivers, Stress reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 13 Sep 2025 (actual)
- Study completion
- 13 Sep 2025 (actual)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Meditation Intervention | Experimental | Behavioral: Mindfulness-Based Digital Intervention (AIZEN Program)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Immediate Meditation Intervention |
Primary outcome
Change in Personal Burnout (Copenhagen Burnout Inventory, Professional Caregivers)
Time frame: Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)
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.
Change in Work-Related Burnout (Copenhagen Burnout Inventory, Professional Caregivers)
Time frame: Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)
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.
Change in Client-Related Burnout (Copenhagen Burnout Inventory, Professional Caregivers)
Time frame: Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)
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.
1 secondary outcome
Change in Caregiver Burden (Zarit Burden Interview, Informal Caregivers)
Time frame: Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Digital Intervention (AIZEN Program) in people with Burnout, Professional and Caregivers, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Personal Burnout (Copenhagen Burnout Inventory, Professional Caregivers) (time frame: Baseline (Week 0), Post-intervention (Week 5), and Follow-up (Week 10)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.