MindfulnessNCT06821230
Dyadic Mindfulness for People With Parkinson's Disease and Their Caregivers
A study testing Dyadic mindfulness in people with Mindfulness and Caregivers, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mindfulness, Caregivers, Movement Disorders
- What is being tested?
- Dyadic mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Feb 2025to 30 Jun 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
- Chinese patients with idiopathic mild-moderate PD (as indicated by the Hoehn and Yahr Scale stages I-III: those with unilateral/bilateral symptoms, with/without postural instability who are able to walk/stand unassisted)
- Aged ≥18 years
- Self-identified as the primary caregivers of their patient
- Either patient or caregiver needs to experience at least mild negative emotions (as indicated by the 21-item Depression, Anxiety and Stress Scale [DASS21] score of Depression subscale ≥10, Anxiety subscale ≥8, or Stress subscale ≥15)
- Both need to be able to communicate in Cantonese and provide written consent.
Who cannot join
- Engage in regular supervised mind-body practices such as Tai Chi, yoga, or other forms of mindfulness training (>2 times per week)
- Have a pre-existing acute psychotic disease
- Currently participating in any other behavioral or pharmacological trial
- Have significant cognitive impairment, as indicated by an Abbreviated Mental Test score≤ 6
- Have other contraindications that may limit their full participation (e.g., severe hearing/vision impairment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, The University of Hong Kong
Hong Kong
Jojo Yan Yan Kwok, +852 39176644, jojoyyk@hku.hk
About this study
Official title: Enhancing Psychological Wellbeing and the Patient-caregiver Relationship Through Dyadic Mindfulness: A Randomized Controlled Trial in People With Parkinson's Disease and Their Caregivers
The proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. One hundred Chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. Outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, HRQOL, gut microbiome, PD-related symptoms, and caregiving burden. An actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. The dyads will be assessed at baseline(T0), post-intervention(T1), and 4-months post-intervention(T2). The investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness/ineffectiveness of the intervention. Generalized linear mixed-effects (GLME) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. The findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. This study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in PwPD and caregivers to clinically severe levels. Its self-help nature also enriches the primary care for this clinical cohort.
- Conditions
- Mindfulness, Caregivers, Movement Disorders, Neurodegenerative Disease, Dyadic Intervention, Psychosocial Health
- Being tested
- Dyadic mindfulness
- Keywords
- Parkinsons disease, Mindfulness, dyadic care
- Medical subject headings
- Movement Disorders, Neurodegenerative Diseases, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic mindfulnessBehavioural
The dyadic mindfulness intervention group will receive 8 weekly 90-min sessions, with a total of 12 contact hours. The intervention will be delivered in a small group format with 6-8 dyads each and led by a certified yoga instructor with mindfulness qualifications. The program content mindfulness meditation, mindful breathing, and yoga sequences with warm-up and cool-down and each component is modified to pair-based practices.
| Study group | Role | What they receive |
|---|---|---|
| Dyadic mindfulness group | Experimental | Not described Receives: Behavioral: Dyadic mindfulness |
| Wait-list usual care control group | No intervention | The wait-list, usual care control group will continue with routine outpatient services (medication follow-up care with minimal health education on disease management/drug care) and then receive dyadic mindfulness training after the 6-month study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative emotions
Negative emotions (primary outcome) will be measured by validated Chinese DASS-21 using a one-week recall period, which was developed to measure three related and clinically significant negative emotional states of depression, anxiety and stress. Each item is rated on a 0-3 scale (0="Did not apply to me at all" to 3="Applied to me very much or most of the time"). The score of each subscale ranges from 0-42 and the total score ranges from 0-126, with higher score indicating greater self-reported levels of depression, anxiety and stress.
Measured: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
Secondary outcomes (6)
Patient-caregiver relationship
Patient-caregiver relationship will be measured by the validated Chinese Dyadic Relationship Scale, which comprises two subscales: dyadic strain and positive dyadic interaction. Each item is rated on a four-point Likert-type scale ranging from 0 (strongly agree) to 3 (strongly disagree).
Measured: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
Mindfulness
Mindfulness will be measured by the validated Chinese 32-item Multidimensional Assessment of Interoceptive Awareness (MAIA). 36 Using a six-point Likert scale, eight domains will be assessed: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening and trusting.
Measured: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
HRQOL
HRQOL will be measured by the validated Chinese EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L). It comprises 2 main components: a description of health status in 5 dimensions (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), and a numeric value of overall health status perceived by the respondents (EQ-VAS). Each dimension is scored on a 5-point Likert scale, from 0 (no problems) to 4 (extreme problems). The EQ-VAS records an individual's self-rated health on a numeric analogue visual scale from 0 (the worst health) to 100 (the best health).
Measured: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
Gut microbiome
Gut microbiome. All participants will be instructed to self-collect a fecal sample any time during the week of the study visits. Samples will be kept in a collection tube with a stabilizer and stored at room temperature. The fecal sample collection procedure will be guided by a previously tested information leaflet and YouTube video. The research team will collect the samples during the study visits and transfer them to labeled cryovials within 60 days of collection according to the manufacturer's protocol. The samples will then be stored at -80◦C until further analysis.
Measured: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
PD-related motor and non-motor symptoms
PD-related motor and non-motor symptoms will be measured by the validated Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Chinese) Parts I-III, which examine non-motor experiences, motor experiences of daily living, and clinical examination of motor symptoms, respectively. Higher scores indicate greater disease severity.
Measured: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
Caregiving burden
Caregiving burden will be made using the validated 12-item Zarit Burden Interview-short version, which assesses three domains on a five-point scale (0= "never"; 4="very frequently"): perceived role strain, self-criticism, and negative emotion. Higher scores indicate a heavier caregiving burden.
Measured: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start11 Feb 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Responsible party
- Principal investigator, Kwok Yan Yan, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821230
- Sponsor's protocol ID
- 17605424
- Status last verified
- May 2026
- First submitted
- 6 Feb 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data supporting the findings of this study are available upon request from the principal investigator, Prof. Kwok. These data are not publicly available, as they contain information that could compromise the privacy of research participants.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Psychological Wellbeing and the Patient-caregiver Relationship Through Dyadic Mindfulness: A Randomized Controlled Trial in People With Parkinson's Disease and Their Caregivers
- ClinicalTrials.gov ID
- NCT06821230
- Acronym / sponsor ID
- 17605424
- Conditions
- Mindfulness, Caregivers, Movement Disorders, Neurodegenerative Disease, Dyadic Intervention, Psychosocial Health
- Keywords
- Parkinsons disease, Mindfulness, dyadic care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Feb 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 proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with Parkinson's Disease (PwPD) and their family caregivers. One hundred Chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. Outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, HRQOL, gut microbiome, PD-related symptoms, and caregiving burden. An actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. The dyads will be assessed at baseline(T0), post-intervention(T1), and 4-months post-intervention(T2). The investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness/ineffectiveness of the intervention. Generalized linear mixed-effects (GLME) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. The findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. This study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in PwPD and caregivers to clinically severe levels. Its self-help nature also enriches the primary care for this clinical cohort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyadic mindfulness group | Experimental | Behavioral: Dyadic mindfulness |
| Wait-list usual care control group | No intervention | –The wait-list, usual care control group will continue with routine outpatient services (medication follow-up care with minimal health education on disease management/drug care) and then receive dyadic mindfulness training after the 6-month study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese patients with idiopathic mild-moderate PD (as indicated by the Hoehn and Yahr Scale stages I-III: those with unilateral/bilateral symptoms, with/without postural instability who are able to walk/stand unassisted)
- Aged ≥18 years
- Self-identified as the primary caregivers of their patient
- Either patient or caregiver needs to experience at least mild negative emotions (as indicated by the 21-item Depression, Anxiety and Stress Scale [DASS21] score of Depression subscale ≥10, Anxiety subscale ≥8, or Stress subscale ≥15)
- Both need to be able to communicate in Cantonese and provide written consent.
Key exclusion criteria (5 listed)
- Engage in regular supervised mind-body practices such as Tai Chi, yoga, or other forms of mindfulness training (>2 times per week)
- Have a pre-existing acute psychotic disease
- Currently participating in any other behavioral or pharmacological trial
- Have significant cognitive impairment, as indicated by an Abbreviated Mental Test score≤ 6
- Have other contraindications that may limit their full participation (e.g., severe hearing/vision impairment)
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 |
|---|---|---|
| Dyadic mindfulnessThe dyadic mindfulness intervention group will receive 8 weekly 90-min sessions, with a total of 12 contact hours. The intervention will be delivered in a small group format with 6-8 dyads each and led by a certified yoga instructor with mindfulness qualifications. The program content mindfulness meditation, mindful breathing, and yoga sequences with warm-up and cool-down and each component is modified to pair-based practices. | Behavioural | Dyadic mindfulness group |
Primary outcome
Negative emotions
Time frame: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
Negative emotions (primary outcome) will be measured by validated Chinese DASS-21 using a one-week recall period, which was developed to measure three related and clinically significant negative emotional states of depression, anxiety and stress. Each item is rated on a 0-3 scale (0="Did not apply to me at all" to 3="Applied to me very much or most of the time"). The score of each subscale ranges from 0-42 and the total score ranges from 0-126, with higher score indicating greater self-reported levels of depression, anxiety and stress.
6 secondary outcomes
Patient-caregiver relationship
Time frame: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
Mindfulness
Time frame: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
HRQOL
Time frame: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
Gut microbiome
Time frame: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
PD-related motor and non-motor symptoms
Time frame: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).
Caregiving burden
Time frame: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 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 1 Jun 2026.
- Individual participant dataSharing planned: No. The data supporting the findings of this study are available upon request from the principal investigator, Prof. Kwok. These data are not publicly available, as they contain information that could compromise the privacy of research participants.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic mindfulness in people with Mindfulness and Caregivers, run by The 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 5 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: looking for participants now, as of the sponsor's last update on 1 Jun 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?
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 Jojo Yan Yan Kwok (852 39176644, jojoyyk@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative emotions (time frame: A repeated outcome measure will be conducted at baseline (T0, prior to randomization), immediate post-intervention (T1, 2 months) and 4-months post-intervention (T2, 6 months).). 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 1 Jun 2026.