- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06302504
Nature-based Mindfulness Intervention Program for Family Carers
February 26, 2025 updated by: The Hong Kong Polytechnic University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong, 852
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nature-based mindfulness program
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.
|
only one arm is included in this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
|
|
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)
|
Change from 1-month before intervention, pre-intervention, to 1 month follow-up, to 3-month after intervention
|
|
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)
|
Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
|
|
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
|
Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
|
|
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
|
Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
|
|
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
|
Change from 1-month before intervention, pre-intervention, to 1-month follow-up, to 3-month after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2023
Primary Completion (Actual)
March 31, 2024
Study Completion (Actual)
May 31, 2024
Study Registration Dates
First Submitted
March 4, 2024
First Submitted That Met QC Criteria
March 4, 2024
First Posted (Actual)
March 8, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Nature
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The funder decided not to share the data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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