Mental Health IssueNCT06302504
Nature-based Mindfulness Intervention Program for Family Carers
A study testing Nature-based mindfulness program in people with Mental Health Issue, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Nature-based mindfulness program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Apr 2023to 31 May 2024
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- parents with children experiencing divorce or separation
- parents of children with special needs
- family caregivers who are the primary caregivers of an older adult with dementia
Who cannot join
- parents or caregivers who cannot understand Cantonese version of Chinese
- parents or caregivers who have psychosis or developmental disabilities who are not able to comprehend the program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nature-based Mindfulness Intervention Program for Family Caregivers with High Levels of Caring Related Stress
The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total.
- Conditions
- Mental Health Issue
- Being tested
- Nature-based mindfulness program
- Keywords
- caregiver, mindfulness-based program, nature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-based mindfulness programBehavioural
only one arm is included in this study
| Study group | Role | What they receive |
|---|---|---|
| Nature-based mindfulness program | Experimental | The program will include mindfulness exercises, including body scan, mindful stretching, mindful sitting, and befriending exercise. At least one of the four sessions will be conducted in retreat center in nature area. Receives: Behavioral: Nature-based mindfulness program |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression
measured by Depression Anxiety and Stress Scale (DASS-21)
Measured: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
anxiety
measured by Depression Anxiety and Stress Scale (DASS-21)
Measured: Change from 1-month before intervention, pre-intervention, to 1 month follow-up, to 3-month after intervention
stress
measured by Depression Anxiety and Stress Scale (DASS-21)
Measured: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
family functioning
measured by The Family Adaptation, Partnership, Growth, Affection, Resolve Scale
Measured: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
family conflict
measured by The Conflict Tactics Scale
Measured: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
well-being
measured by The World Health Organization Well-being Index
Measured: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 Apr 2023
- Primary completion31 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302504
- Sponsor's protocol ID
- Nature
- Status last verified
- Feb 2025
- First submitted
- 4 Mar 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The funder decided not to share the data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nature-based Mindfulness Intervention Program for Family Caregivers with High Levels of Caring Related Stress
- ClinicalTrials.gov ID
- NCT06302504
- Acronym / sponsor ID
- Nature
- Conditions
- Mental Health Issue
- Keywords
- caregiver, mindfulness-based program, nature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 8 Mar 2024 (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 program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nature-based mindfulness program | Experimental | Behavioral: Nature-based mindfulness programThe program will include mindfulness exercises, including body scan, mindful stretching, mindful sitting, and befriending exercise. At least one of the four sessions will be conducted in retreat center in nature area. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- parents with children experiencing divorce or separation
- parents of children with special needs
- family caregivers who are the primary caregivers of an older adult with dementia
Key exclusion criteria (2 listed)
- parents or caregivers who cannot understand Cantonese version of Chinese
- parents or caregivers who have psychosis or developmental disabilities who are not able to comprehend the program
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 |
|---|---|---|
| Nature-based mindfulness programonly one arm is included in this study | Behavioural | Nature-based mindfulness program |
Primary outcome
depression
Time frame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
measured by Depression Anxiety and Stress Scale (DASS-21)
anxiety
Time frame: Change from 1-month before intervention, pre-intervention, to 1 month follow-up, to 3-month after intervention
measured by Depression Anxiety and Stress Scale (DASS-21)
stress
Time frame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
measured by Depression Anxiety and Stress Scale (DASS-21)
family functioning
Time frame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
measured by The Family Adaptation, Partnership, Growth, Affection, Resolve Scale
family conflict
Time frame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
measured by The Conflict Tactics Scale
well-being
Time frame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
measured by The World Health Organization Well-being Index
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 3 Mar 2025.
- Individual participant dataSharing planned: No. The funder decided not to share the data.
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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 Nature-based mindfulness program in people with Mental Health Issue, run by The Hong Kong Polytechnic University 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 3 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 3 Mar 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 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?
depression (time frame: Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention). The study lists 6 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 3 Mar 2025.