Dementia CaregiverNCT07714681
Developing and Testing a Brief Mindfulness Just-in-time Adaptive Intervention for Reducing Stress of Dementia Caregivers
A study testing Group 1 - Vulnerability and Group 2 - Receptivity in people with Dementia Caregiver, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
1. To determine an effective decision rule for delivering brief mindfulness prompts as a function of caregivers' real-time stress state, including whether prompt delivery affects subsequent stress and affect and whether this effect varies by stress state at the decision point. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Caregiver
- What is being tested?
- Group 1 - Vulnerability and Group 2 - Receptivity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Nov 2024to 31 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- family dementia caregivers aged 18 above
- family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community
- having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment
- have a smartphone
- have moderate to high stress
Who cannot join
- Having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment
- Having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers participation or adherence (e.g. acute psychosis).
Trial locations and contacts
1 site in 1 country.
About this study
- To determine an effective decision rule for delivering brief mindfulness prompts as a function of caregivers' real-time stress state, including whether prompt delivery affects subsequent stress and affect and whether this effect varies by stress state at the decision point.
- To determine an effective JITAI decision rule to deliver a brief mindfulness intervention depending the current state of stress of caregivers and to examine if the adaptive model of machine learning algorithm generate higher receptivity of the brief intervention than the static and control model at the end of the four weeks.
- To evaluate the feasibility, acceptability, and preliminary effects of the brief mindfulness just-in-time adaptive intervention on perceived stress and related caregiver outcomes.
- Conditions
- Dementia Caregiver
- Being tested
- Group 1 - Vulnerability, Group 2 - Receptivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 - VulnerabilityBehavioural
In the first phase of the study, participants will be interviewed by a research assistant over the phone with a structured questionnaire on the first day of the study period. They will then receive a four-day psycho-education intervention, during which the study application will be installed on their smartphone. At the end of the fourth day, participants will be asked to use the app for the following 16 days of the micro-randomized trial (MRT). In the 16-day MRT (Day 5 to Day 20), zero to six ecological momentary assessments (EMAs), separated by at least 30 minutes, will be delivered each day (from one hour after self-reported wake time to one hour before self-reported sleep time) to classify whether the participant is probably-stressed or probably-not-stressed using a single stress item. Immediately following each EMA, participants will be randomized to receive a brief mindfulness intervention prompt or no prompt, with randomization occurring only if no brief mindfulness intervention
Group 2 - ReceptivityBehavioural
In the second phase, the receptivity of the brief mindfulness intervention will be examined within a just-in-time adaptive intervention (JITAI) framework, comprising distal outcomes, a proximal outcome (engagement with the brief intervention), decision points, intervention options (which notification-delivery model is applied), a tailoring variable (predicted receptivity), and decision rules. In the first four days, as in the first phase, participants will be interviewed with a structured questionnaire and will receive a four-day psycho-education intervention. Over the subsequent 14-day micro-randomized trial (Day 5 to Day 18), notification-delivery models will be randomized at scheduled daily decision points. From Day 5 to Day 11, prompts will be delivered by either a random or a static machine-learning model with equal probability; from Day 12 to Day 18, prompts will be delivered by a random, static, or adaptive machine-learning model with equal probability, with the adaptive model u
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Behavioral: Group 1 - Vulnerability |
| Group 2 | Experimental | Not described Receives: Behavioral: Group 2 - Receptivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress
14-item perceived stress scale. Items are rated on a 5-point Likert scale, ranging from 0-56,with higher scores indicating greater perceived stress.
Measured: baseline and immediately after intervention
Secondary outcomes (6)
Depressive Symptoms
Patient health questionnaire 9, items are rated on a 4-point scale, ranging from 0 to 27, with higher scores reflecting greater depression severity.
Measured: baseline and immediately after intervention
caregiving burden
12-item Zarit Burden Interview, items are rated on a 5-point scale, ranging from 0-48, with higher scores denoting greater burden.
Measured: baseline and immediately after intervention
Positive Aspect of Caregiving
Positive Aspects of Caregiving Scale, items are rated on a 5-point Likert scale, ranging from 9-45, with higher scores indicating a more positive appraisal
Measured: baseline and immediately after intervention
sleep quality
Pittsburgh Sleep Quality Index, score ranging from 0-21, with higher scores indicate poorer sleep quality.
Measured: baseline and immediately after intervention
quality of life
EuroQoL 5-Dimension 5-Level measures across 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), score ranging from 0-100, higher scores reflect better health-related quality of life.
Measured: baseline and immediately after intervention
Mindfulness
15-item Mindful Attention Awareness Scale, items are rated on a 6-point scale, score ranging from 1-6, with higher scores indicating greater dispositional mindfulness.
Measured: baseline and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start18 Nov 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia CaregiverStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University, Lingnan University, Columbia University, Penn State University
- Responsible party
- Principal investigator, Chou Kee Lee, Education University of Hong Kong
- Investigators
- Kee Lee Chou, PhD, Principal investigator, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714681
- Sponsor's protocol ID
- 2021-2022-0276
- Other IDs
- 20210051
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 20 Jul 2026
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Brief Mindfulness Just-in-time Adaptive Intervention for Reducing Stress of Dementia Caregivers
- ClinicalTrials.gov ID
- NCT07714681
- Acronym / sponsor ID
- 2021-2022-0276
- Conditions
- Dementia Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University, Lingnan University, Columbia University, Penn State University
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Jul 2026 (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.
- To determine an effective decision rule for delivering brief mindfulness prompts as a function of caregivers' real-time stress state, including whether prompt delivery affects subsequent stress and affect and whether this effect varies by stress state at the decision point.
- To determine an effective JITAI decision rule to deliver a brief mindfulness intervention depending the current state of stress of caregivers and to examine if the adaptive model of machine learning algorithm generate higher receptivity of the brief intervention than the static and control model at the end of the four weeks.
- To evaluate the feasibility, acceptability, and preliminary effects of the brief mindfulness just-in-time adaptive intervention on perceived stress and related caregiver outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Group 1 - Vulnerability |
| Group 2 | Experimental | Behavioral: Group 2 - Receptivity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- family dementia caregivers aged 18 above
- family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community
- having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment
- have a smartphone
- have moderate to high stress
Key exclusion criteria (2 listed)
- Having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment
- Having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers participation or adherence (e.g. acute psychosis).
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 |
|---|---|---|
| Group 1 - VulnerabilityIn the first phase of the study, participants will be interviewed by a research assistant over the phone with a structured questionnaire on the first day of the study period. They will then receive a four-day psycho-education intervention, during which the study application will be installed on their smartphone. At the end of the fourth day, participants will be asked to use the app for the following 16 days of the micro-randomized trial (MRT). In the 16-day MRT (Day 5 to Day 20), zero to six ecological momentary assessments (EMAs), separated by at least 30 minutes, will be delivered each day (from one hour after self-reported wake time to one hour before self-reported sleep time) to classify whether the participant is probably-stressed or probably-not-stressed using a single stress item. Immediately following each EMA, participants will be randomized to receive a brief mindfulness intervention prompt or no prompt, with randomization occurring only if no brief mindfulness intervention | Behavioural | Group 1 |
| Group 2 - ReceptivityIn the second phase, the receptivity of the brief mindfulness intervention will be examined within a just-in-time adaptive intervention (JITAI) framework, comprising distal outcomes, a proximal outcome (engagement with the brief intervention), decision points, intervention options (which notification-delivery model is applied), a tailoring variable (predicted receptivity), and decision rules. In the first four days, as in the first phase, participants will be interviewed with a structured questionnaire and will receive a four-day psycho-education intervention. Over the subsequent 14-day micro-randomized trial (Day 5 to Day 18), notification-delivery models will be randomized at scheduled daily decision points. From Day 5 to Day 11, prompts will be delivered by either a random or a static machine-learning model with equal probability; from Day 12 to Day 18, prompts will be delivered by a random, static, or adaptive machine-learning model with equal probability, with the adaptive model u | Behavioural | Group 2 |
Primary outcome
Perceived Stress
Time frame: baseline and immediately after intervention
14-item perceived stress scale. Items are rated on a 5-point Likert scale, ranging from 0-56,with higher scores indicating greater perceived stress.
6 secondary outcomes
Depressive Symptoms
Time frame: baseline and immediately after intervention
caregiving burden
Time frame: baseline and immediately after intervention
Positive Aspect of Caregiving
Time frame: baseline and immediately after intervention
sleep quality
Time frame: baseline and immediately after intervention
quality of life
Time frame: baseline and immediately after intervention
Mindfulness
Time frame: baseline and immediately after intervention
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 20 Jul 2026.
- 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.
Kee Lee Chou, PhD principal investigator
The Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 - Vulnerability and Group 2 - Receptivity in people with Dementia Caregiver, run by Education University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 2 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 20 Jul 2026. 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 Hong Kong. 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?
Perceived Stress (time frame: baseline and immediately after intervention). 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 20 Jul 2026.