Caregiving StressNCT06880822
Closed-Loop and Neuroplasticity-Based Mindfulness Program for Family Caregivers
A study testing Closed-Loop and Neuroplasticity-Based Mindfulness Program, Traditional Mindfulness Program (Without the Closed-Loop Approach) and Psychoeducation in people with Caregiving Stress, run by The Hong Kong Polytechnic University.
Trial summary
The aim of this study is to evaluate the effectiveness of a closed-loop and neuroplasticity-based mindfulness program for reducing stress among family caregivers of people with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiving Stress
- What is being tested?
- Closed-Loop and Neuroplasticity-Based Mindfulness Program, Traditional Mindfulness Program (Without the Closed-Loop Approach) and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 or above;
- Family caregiver of an individual who has been living in the community with a confirmed medical diagnosis of any type of dementia (verified through NGO records or care recipient's medical records) for more than one year;
- Living in the same household as the care recipient;
- Providing care with daily contact of 4 hours or more.
Who cannot join
- Has participated in any structured mind-body intervention or structured psychosocial intervention within 6 months prior to recruitment;
- Has an acute psychiatric condition that is potentially life-threatening or would limit participation in the study (indicated by answering "yes" to any of the six questions on the Columbia Suicide Severity Rating Scale).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of a Closed-Loop and Neuroplasticity-Based Mindfulness Program for Reducing Stress in Family Caregivers of People with Dementia: a Randomized Controlled Trial with a Process Evaluation
The aim of this study is to evaluate the effectiveness of a closed-loop and neuroplasticity-based mindfulness program for reducing stress among family caregivers of people with dementia. Participants will be randomly assigned to one of three groups: the closed-loop and neuroplasticity-based mindfulness program, a traditional mindfulness program, or brief education on dementia care. The closed-loop and neuroplasticity-based mindfulness program will include three weekly face-to-face training sessions (90 minutes each) and daily guided self-practice over 8 weeks via a mobile application. The traditional mindfulness program will not include the closed-loop approach but will feature general mindfulness practices with the same group size, duration, and frequency as the closed-loop program. The family caregivers in the control group will receive self-directed e-learning on dementia care with support from a registered nurse experienced in dementia care or elderly care, maintaining the same group size, duration, and frequency as the intervention groups. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). All groups will complete the same assessments at the same time points.
Read the detailed description
Demanding caregiving tasks and uncertainty about disease progression cause high levels of stress in family caregivers of people with dementia (PWD), threatening their health and dyadic relationships. While mindfulness-based interventions (MBI) have shown promise in reducing stress, several limitations exist. Most studies used intensive training (weekly 150-minute sessions for 8 weeks), which was demanding for family caregivers and led to high attrition rates (10.5%-17.2%). Additionally, a wandering mind during practice has been the most challenging aspect of mindfulness. Traditional mindfulness practices lack quantifiable metrics of success or performance feedback, making engagement and long-term compliance difficult. Recent studies of online mindfulness programs found they typically duplicated real-world practices, encountering similar implementation challenges. Furthermore, the manualized protocol (e.g., 45 minutes of daily practice) was often unachievable for many caregivers, leading to frustration. Mindfulness training should adapt to individual abilities. To address these limitations, the investigators propose integrating a closed-loop and neuroplasticity-based approach in mindfulness training.
The study will recruit community-dwelling family caregivers of people with dementia from three local nongovernmental organizations (NGOs) providing dementia care services in Hong Kong. After eligibility assessment and consent, participants will be randomly assigned to one of three groups: the closed-loop and neuroplasticity-based mindfulness program, a traditional mindfulness program, or brief education on dementia care.
The closed-loop and neuroplasticity-based mindfulness program comprises three weekly face-to-face mindfulness training sessions (90 minutes each) and daily guided self-practice through a mobile application over 8 weeks. The face-to-face training will incorporate the mobile application and various mindfulness practices to help caregivers integrate mindfulness skills into daily life. Facilitators will provide weekly mobile device follow-up to monitor progress.
Family caregivers in the traditional mindfulness group will practice general mindfulness techniques without the closed-loop approach. These practices will be delivered through a mobile approach with identical group size, duration, and frequency as the intervention group.
The brief education on dementia care group will receive self-directed e-learning supported by an experienced registered nurse. This control group will maintain the same group size, duration, and frequency as the intervention groups. Educational content will include sessions on dementia care, caregiving skills, and group sharing.
Outcome measures include perceived caregiving stress (primary outcome), depressive symptoms, peace of mind, caregiving burden, dyadic relationship, dispositional mindfulness, physiological stress, neuropsychiatric symptoms, and caregiving-related productivity loss. Feasibility measures include eligibility and enrollment, attendance rate, self-practice engagement, and retention rate. Evaluations will occur at baseline (0 weeks), post-intervention (8 weeks), and follow-up (6 months). All groups will complete identical assessments at the same time points.
- Conditions
- Caregiving Stress
- Being tested
- Closed-Loop and Neuroplasticity-Based Mindfulness Program, Traditional Mindfulness Program (Without the Closed-Loop Approach), Psychoeducation
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-Loop and Neuroplasticity-Based Mindfulness ProgramBehavioural
The intervention includes three weekly 90-minute face-to-face mindfulness training sessions and daily guided self-practice using a closed-loop, neuroplasticity-based mobile app over 8 weeks. Training integrates mindfulness practices (e.g., mindful eating, body scanning) to help caregivers apply mindfulness in daily life. During self-practice, participants listen to a lesson, monitor distractions, and refocus on their breathing. Initial trials start at 20 seconds, adjusting by 10% if focused or decreasing by 20% if distracted, helping participants regulate attention. Progress is stored to continue in later sessions, with instant feedback during trials and delayed feedback on overall progress. Facilitators provide weekly follow-ups via the app to monitor caregivers' progress.
Traditional Mindfulness Program (Without the Closed-Loop Approach)Behavioural
Family caregivers in the traditional mindfulness group will participate in general mindfulness practices (e.g., mindful eating, body scanning, and mindful walking) without the closed-loop approach. These practices aim to help caregivers learn mindfulness skills and integrate them into their everyday life. Sessions will be delivered through a mobile approach with the same group size, duration, and frequency as the intervention groups.
PsychoeducationBehavioural
Family caregivers in the control group will receive self-directed e-learning on dementia care with support from a registered nurse experienced in dementia care or elderly care. This group will serve as a control for socialization and interaction aspects with peers and the interventionist (nurse). The self-directed learning will be delivered through a mobile approach, maintaining the same group size, duration, and frequency as the intervention groups. Educational content will include brief sessions on dementia care, caregiving skills, and group sharing of caregiving tasks.
| Study group | Role | What they receive |
|---|---|---|
| Closed-Loop and Neuroplasticity-Based Mindfulness Program | Experimental | Not described Receives: Behavioral: Closed-Loop and Neuroplasticity-Based Mindfulness Program |
| Traditional Mindfulness Program (Without the Closed-Loop Approach) | Active comparator | Not described Receives: Behavioral: Traditional Mindfulness Program (Without the Closed-Loop Approach) |
| Psychoeducation | Active comparator | Not described Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Caregiving Stress in the Family Caregiver
The Perceived Stress Scale (PSS) comprises 10 items rated on a 5-point Likert Scale (0 = never to 4 = very often) to assess perceived stress levels. The total score varies from 0 to 40, with a higher score reflecting more perceived stress. Scores within the ranges of 0-13, 14-26, and 27-40 correspond to low, moderate, and high levels of perceived stress, respectively.
Measured: 6 months
Secondary outcomes (12)
Depressive Symptoms in the Family Caregiver
The Center for Epidemiologic Studies Depression Scale (CESD) comprises 20 items rated on a 4-point Likert scale (0 = rarely or none of the time to 3 = most or almost all the time) to assess the severity of depressive symptoms experienced in the past week. The total score ranges from 0 to 60, with a higher score indicating more severe depressive symptoms. Scores within the ranges of 0-14, 15-21, and 22-60 correspond to low, mild to moderate, and a potential indication of major depression, respectively.
Measured: 6 months
Peace of Mind in the Family Caregiver
The Peace of Mind Scale (PMS) consists of 7 items rated on a 5-point Likert scale (1 = not at all to 5 = all the time) that assess an internal state of peacefulness and harmony. Two items are reverse-scored. The total score ranges from 7 to 35, with higher scores indicating greater levels of peacefulness and harmony.
Measured: 6 months
Caregiving Burden in the Family Caregiver
The Zarit Burden Interview (ZBI) consists of 22 items that measure the impact of caregiving on physical health, emotional well-being, social life, and financial status. Items are rated on a 5-point Likert scale (0 = never to 4 = nearly always). Total scores range from 0 to 88, with higher scores indicating greater caregiving burden.
Measured: 6 months
Dyadic Relationship Between the Family Caregiver and the Care Recipient
The Dyadic Relationship Scale (DRS) measures the quality of the dyadic relationship between the family caregiver and the care recipient. This scale consists of two versions: the patient version (10 items) and the caregiver version (11 items). Both versions include two subscales: dyadic strain and positive dyadic interaction. They are rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). Higher scores on each of these scales indicate higher levels of strain and positive interaction, respectively.
Measured: 6 months
Dispositional Mindfulness in the Family Caregiver
The Mindful Attention Awareness Scale (MAAS) consists of 15 items that measure the core characteristics of dispositional mindfulness: receptive awareness and present-moment attention. Items are rated on a 6-point scale (1 = almost always to 6 = almost never). Total scores range from 15 to 90, with higher scores indicating greater levels of dispositional mindfulness.
Measured: 6 months
Physiological Stress in the Family Caregiver
Physiological stress will be measured by heart rate variability (HRV) using the CorSense Heart Rate Variability Finger Sensor. HRV will be interpreted following the Guidelines for the Standard Measurement and Interpretation of HRV (European Society of Cardiology and the North American Society of Pacing and Electrophysiology) using the frequency-domain method.
Measured: 6 months
Work Productivity and Activity Impairment in the Family Caregivers
The Work Productivity and Activity Impairment Questionnaire for Caregivers (WPAI:CG) consists of 6 items that measure productivity loss due to caregiving responsibilities. The questionnaire assesses four main outcomes: absenteeism (percentage of work time missed due to caregiving), presenteeism (percentage impairment while working due to caregiving), work productivity loss (percentage overall work impairment due to caregiving), and activity impairment (percentage activity impairment due to caregiving). The recall period is 7 days. Higher scores indicate greater impairment and less productivity. Total work productivity loss scores range from 0 to 100%, with higher percentages indicating greater impairment.
Measured: 6 months
Neuropsychiatric Syndromes in the Care Recipient
The Neuropsychiatric Inventory (NPI) measures neuropsychiatric syndromes that occur in Alzheimer's disease and other neurodegenerative disorders. The NPI is administered by the family caregiver and consists of the following domains: Delusions, Hallucinations, Agitation/Aggression, Depression/Dysphoria, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability/Lability, and Aberrant Motor Behavior. Each domain is rated based on its frequency (1 = rarely, less than once per week; 4 = very often, once or more per day) and severity (1 = mild, producing little distress in the patient; 3 = severe, very disturbing to the patient and difficult to redirect). A total score can be obtained for each domain by multiplying the frequency and severity ratings. The total score of the NPI is obtained by summing the scores across all domains, with a higher score indicating more severe neuropsychiatric syndromes.
Measured: 6 months
Feasibility of Eligibility and Enrollment
Number of eligible participants, and the proportion of those eligible that enrolled will be assessed.
Measured: 8 weeks
Feasibility of Attendance Rate
Number and proportion of attended participants.
Measured: 8 weeks
Feasibility of Engagement to Self-Practice
Engagement with mindfulness practice will be determined by the duration of mindfulness practice as recorded through the participants' mobile application.
Measured: 6 months
Feasibility of Retention Rate
Number and proportion of participants completing all assessments.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiving StressStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick KOR Pui Kin, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880822
- Sponsor's protocol ID
- HSEARS20240722001
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The intervention protocol will be published.
Publications
Kor PPK, Chou KL, Tsang APL, Mak WWS, Galante J, Ho RTH, Wong SYS, Cheung DSK, Liu JYW, Zarit SH. Effects of a closed-loop mindfulness-based program for reducing stress in family caregivers of people with dementia: a study protocol of a randomized controlled trial. BMC Psychol. 2025 Jul 1;13(1):681. doi: 10.1186/s40359-025-02919-2.
PubMed 40597419
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Closed-Loop and Neuroplasticity-Based Mindfulness Program for Reducing Stress in Family Caregivers of People with Dementia: a Randomized Controlled Trial with a Process Evaluation
- ClinicalTrials.gov ID
- NCT06880822
- Acronym / sponsor ID
- HSEARS20240722001
- Conditions
- Caregiving Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 18 Mar 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 aim of this study is to evaluate the effectiveness of a closed-loop and neuroplasticity-based mindfulness program for reducing stress among family caregivers of people with dementia. Participants will be randomly assigned to one of three groups: the closed-loop and neuroplasticity-based mindfulness program, a traditional mindfulness program, or brief education on dementia care. The closed-loop and neuroplasticity-based mindfulness program will include three weekly face-to-face training sessions (90 minutes each) and daily guided self-practice over 8 weeks via a mobile application. The traditional mindfulness program will not include the closed-loop approach but will feature general mindfulness practices with the same group size, duration, and frequency as the closed-loop program. The family caregivers in the control group will receive self-directed e-learning on dementia care with support from a registered nurse experienced in dementia care or elderly care, maintaining the same group size, duration, and frequency as the intervention groups. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). All groups will complete the same assessments at the same time points.
Detailed description
Demanding caregiving tasks and uncertainty about disease progression cause high levels of stress in family caregivers of people with dementia (PWD), threatening their health and dyadic relationships. While mindfulness-based interventions (MBI) have shown promise in reducing stress, several limitations exist. Most studies used intensive training (weekly 150-minute sessions for 8 weeks), which was demanding for family caregivers and led to high attrition rates (10.5%-17.2%). Additionally, a wandering mind during practice has been the most challenging aspect of mindfulness. Traditional mindfulness practices lack quantifiable metrics of success or performance feedback, making engagement and long-term compliance difficult. Recent studies of online mindfulness programs found they typically duplicated real-world practices, encountering similar implementation challenges. Furthermore, the manualized protocol (e.g., 45 minutes of daily practice) was often unachievable for many caregivers, leading to frustration. Mindfulness training should adapt to individual abilities. To address these limitations, the investigators propose integrating a closed-loop and neuroplasticity-based approach in mindfulness training.
The study will recruit community-dwelling family caregivers of people with dementia from three local nongovernmental organizations (NGOs) providing dementia care services in Hong Kong. After eligibility assessment and consent, participants will be randomly assigned to one of three groups: the closed-loop and neuroplasticity-based mindfulness program, a traditional mindfulness program, or brief education on dementia care.
The closed-loop and neuroplasticity-based mindfulness program comprises three weekly face-to-face mindfulness training sessions (90 minutes each) and daily guided self-practice through a mobile application over 8 weeks. The face-to-face training will incorporate the mobile application and various mindfulness practices to help caregivers integrate mindfulness skills into daily life. Facilitators will provide weekly mobile device follow-up to monitor progress.
Family caregivers in the traditional mindfulness group will practice general mindfulness techniques without the closed-loop approach. These practices will be delivered through a mobile approach with identical group size, duration, and frequency as the intervention group.
The brief education on dementia care group will receive self-directed e-learning supported by an experienced registered nurse. This control group will maintain the same group size, duration, and frequency as the intervention groups. Educational content will include sessions on dementia care, caregiving skills, and group sharing.
Outcome measures include perceived caregiving stress (primary outcome), depressive symptoms, peace of mind, caregiving burden, dyadic relationship, dispositional mindfulness, physiological stress, neuropsychiatric symptoms, and caregiving-related productivity loss. Feasibility measures include eligibility and enrollment, attendance rate, self-practice engagement, and retention rate. Evaluations will occur at baseline (0 weeks), post-intervention (8 weeks), and follow-up (6 months). All groups will complete identical assessments at the same time points.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Closed-Loop and Neuroplasticity-Based Mindfulness Program | Experimental | Behavioral: Closed-Loop and Neuroplasticity-Based Mindfulness Program |
| Traditional Mindfulness Program (Without the Closed-Loop Approach) | Active comparator | Behavioral: Traditional Mindfulness Program (Without the Closed-Loop Approach) |
| Psychoeducation | Active comparator | Behavioral: Psychoeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or above;
- Family caregiver of an individual who has been living in the community with a confirmed medical diagnosis of any type of dementia (verified through NGO records or care recipient's medical records) for more than one year;
- Living in the same household as the care recipient;
- Providing care with daily contact of 4 hours or more.
Key exclusion criteria (2 listed)
- Has participated in any structured mind-body intervention or structured psychosocial intervention within 6 months prior to recruitment;
- Has an acute psychiatric condition that is potentially life-threatening or would limit participation in the study (indicated by answering "yes" to any of the six questions on the Columbia Suicide Severity Rating Scale).
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 |
|---|---|---|
| Closed-Loop and Neuroplasticity-Based Mindfulness ProgramThe intervention includes three weekly 90-minute face-to-face mindfulness training sessions and daily guided self-practice using a closed-loop, neuroplasticity-based mobile app over 8 weeks. Training integrates mindfulness practices (e.g., mindful eating, body scanning) to help caregivers apply mindfulness in daily life. During self-practice, participants listen to a lesson, monitor distractions, and refocus on their breathing. Initial trials start at 20 seconds, adjusting by 10% if focused or decreasing by 20% if distracted, helping participants regulate attention. Progress is stored to continue in later sessions, with instant feedback during trials and delayed feedback on overall progress. Facilitators provide weekly follow-ups via the app to monitor caregivers' progress. | Behavioural | Closed-Loop and Neuroplasticity-Based Mindfulness Program |
| Traditional Mindfulness Program (Without the Closed-Loop Approach)Family caregivers in the traditional mindfulness group will participate in general mindfulness practices (e.g., mindful eating, body scanning, and mindful walking) without the closed-loop approach. These practices aim to help caregivers learn mindfulness skills and integrate them into their everyday life. Sessions will be delivered through a mobile approach with the same group size, duration, and frequency as the intervention groups. | Behavioural | Traditional Mindfulness Program (Without the Closed-Loop Approach) |
| PsychoeducationFamily caregivers in the control group will receive self-directed e-learning on dementia care with support from a registered nurse experienced in dementia care or elderly care. This group will serve as a control for socialization and interaction aspects with peers and the interventionist (nurse). The self-directed learning will be delivered through a mobile approach, maintaining the same group size, duration, and frequency as the intervention groups. Educational content will include brief sessions on dementia care, caregiving skills, and group sharing of caregiving tasks. | Behavioural | Psychoeducation |
Primary outcome
Perceived Caregiving Stress in the Family Caregiver
Time frame: 6 months
The Perceived Stress Scale (PSS) comprises 10 items rated on a 5-point Likert Scale (0 = never to 4 = very often) to assess perceived stress levels. The total score varies from 0 to 40, with a higher score reflecting more perceived stress. Scores within the ranges of 0-13, 14-26, and 27-40 correspond to low, moderate, and high levels of perceived stress, respectively.
12 secondary outcomes
Depressive Symptoms in the Family Caregiver
Time frame: 6 months
Peace of Mind in the Family Caregiver
Time frame: 6 months
Caregiving Burden in the Family Caregiver
Time frame: 6 months
Dyadic Relationship Between the Family Caregiver and the Care Recipient
Time frame: 6 months
Dispositional Mindfulness in the Family Caregiver
Time frame: 6 months
Physiological Stress in the Family Caregiver
Time frame: 6 months
Work Productivity and Activity Impairment in the Family Caregivers
Time frame: 6 months
Neuropsychiatric Syndromes in the Care Recipient
Time frame: 6 months
Feasibility of Eligibility and Enrollment
Time frame: 8 weeks
Feasibility of Attendance Rate
Time frame: 8 weeks
Feasibility of Engagement to Self-Practice
Time frame: 6 months
Feasibility of Retention Rate
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 40597419Kor PPK, Chou KL, Tsang APL, Mak WWS, Galante J, Ho RTH, Wong SYS, Cheung DSK, Liu JYW, Zarit SH. Effects of a closed-loop mindfulness-based program for reducing stress in family caregivers of people with dementia: a study protocol of a randomized controlled trial. BMC Psychol. 2025 Jul 1;13(1):681. doi: 10.1186/s40359-025-02919-2.
- Individual participant dataSharing planned: Yes. The intervention protocol will be published.
Related trials for Caregiving Stress
Recruiting
Leveraging Interventions for Caregiver Growth, Health, Training, Empowerment and Navigation: Comparing Group Behavioral Interventions to Improve Dementia Caregiver Strain
Elevated Caregiver Strain, Dementia Caregiver
Not yet recruitingPhase 2
Peer Support for Family Caregivers of Older Adults Living With Dementia
Caregiver Burden, Caregiver Burnout
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.
Breast Cancer, Lung Cancer
Active, not recruiting
Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport
Head and Neck Cancer
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.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-Loop and Neuroplasticity-Based Mindfulness Program, Traditional Mindfulness Program (Without the Closed-Loop Approach) and Psychoeducation in people with Caregiving Stress, run by The Hong Kong Polytechnic University.
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 4 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: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Kor, PhD (27665622, patrick.kor@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Caregiving Stress in the Family Caregiver (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06880822, which also lists 1 linked publication.
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 Mar 2025.