- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06813196
Forest Bathing Intervention for Persons Living with Dementia and Family Carers
February 5, 2025 updated by: Choy Chak Pui Jacky, The University of Hong Kong
Forest Bathing Intervention for Persons Living with Dementia and Family Carers: a Feasibility Study
This study assessed the feasibility and acceptability of a forest bathing intervention for people living with dementia and their family carers, and examined its effectivness on care burden and quality of life by comparing to an art activty programme as control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
107
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
-
-
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Hong Kong, Hong Kong
- The University of Hong Kong
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-
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
No
Description
Inclusion Criteria:
- For family careivers:
- taking care of a family member living with dementia in the community,
- For people living with dementia:
- Clinical diagnosis of mild to moderate dementia
Exclusion Criteria:
- For both:
- Unable to communicate in Chinese or Cantonese
- Unable to participate meaningfully in group activities due to intellectual disability, visual impairment, hearing impairment, or other health conditions, were excluded.
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: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Forest bathing
The modified forest bathing intervention was designed by a qualified forest therapist certified by the Association of Nature and Forest Therapy.
The intervention protocol was developed based on existing forest bathing protocol and modified after field-testing with family caregivers.
The intervention consisted of 3 sessions, delivered every two weeks, with approximately two hours per session.
Each session took place at a suitable park in the participant's community.
During the session, a group of 6 to 8 dyads of people living with dementia and their caregivers were guided by a trained forest therapy guide to engage in nature-based activities, such as walking in the woods, listening to the nature, and interacting with objects in the nature through different sensations.
In between sessions, caregivers were encouraged to guide the PLwD and practice similar nature-based activities at times and locations at their convenience.
|
Forest bathing intervention is a group structured psychosocial intervention.
Its core therapeutic element is its nature-based activities that took place in an outdoor green space.
During the session, participants would be guided by a trained forest therapy guide to engage in nature-based activities, such as walking in the woods, listening to the nature, and interacting with objects in the nature through different sensations.
|
|
Active Comparator: Art activity
The art activity intervention was modified from usual art activity session organised by the social service providers for family caregivers and PLwD.
It consisted of 3 sessions, delivered every two weeks, with approximately two hours per session.
Each session took place in an elderly community centre in the participant's neighbourhood.
During the session, participants were guided to engage in individual or collaborative art activities of different forms, such as photo frame of dried flowers, plushball painting, and paper quilling.
All the sessions were delivered by a social worker or program worker with experience in art-based activities.
|
Art activity intervention is a group semi-structured psychosocial intervention.
Its main therapeutic element is its engagement in art-based activites.
During the session, participants would be guided in individual or collaborative art activities of different forms, such as painting, paper arts, and dried flower art, by an experienced interventionist in an activity room.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Caregiver's Care Burden measured by 12-item version of Zarit Burden Interview (ZBI-12)
Time Frame: Baseline and 6 weeks
|
Possible range: 0-48, with higher scores indicate a worse outcome
|
Baseline and 6 weeks
|
|
Change in Caregiver's Depressive Symptoms measured by the Depression subscale of Hospital Anxiety and Depression Scale (HADS-D)
Time Frame: Baseline and 6 weeks
|
Possible range: 0-21, with higher scores indicate a worse outcome
|
Baseline and 6 weeks
|
|
Change in Caregiver's Anxiety Symptoms measured by the Anxiety subscale of Hospital Anxiety and Depression Scale (HADS-A)
Time Frame: Baseline and 6 weeks
|
Possible range: 0-21, with higher scores indicate a worse outcome
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Caregiver's Positive Aspect of Caregiving measured by the Positive Aspect of Caregiving Scale (PACS)
Time Frame: Baseline and 6 weeks
|
Possible range: 11-55, with higher scores indicate a better outcome
|
Baseline and 6 weeks
|
|
Change in Caregiver's Caregiving Self-Efficacy measured by the Revised Scale for Caregiving Self-Efficacy (CSE-R)
Time Frame: Baseline and 6 weeks
|
Possible range: 0-100, with higher scores indicate a better outcome
|
Baseline and 6 weeks
|
|
Change in Caregiver's Health-related Quality of Life measured by the Visual Analogue Scale of EuroQol 5-dimension 5-level (EQ5D5L VAS)
Time Frame: Baseline and 6 weeks
|
Possible range: 0-100, with higher scores indicate a better outcome
|
Baseline and 6 weeks
|
|
Change in Neuropsychiatric Symptoms of Person Living with Dementia measured by the Neuropsychiatric Inventory - Questionnaire (NPI-Q)
Time Frame: Baseline and 6 weeks
|
Possible range: 0-12, with higher scores indicate a worse outcome
|
Baseline and 6 weeks
|
|
Change in Health-related Quality of Life of Person Living with Dementia measured by the Visual Analogue Scale of EuroQol 5-dimension 5-level (EQ5D5L VAS)
Time Frame: Baseline and 6 weeks
|
Possible range: 0-100, with higher scores indicate a better outcome
|
Baseline and 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chak Pui Jacky Choy, PhD, The University of Hong Kong
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 22, 2024
Primary Completion (Actual)
August 17, 2024
Study Completion (Actual)
August 17, 2024
Study Registration Dates
First Submitted
January 27, 2025
First Submitted That Met QC Criteria
February 2, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 5, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA240180
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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