DementiaNCT06813196
Forest Bathing Intervention for Persons Living with Dementia and Family Carers
A study testing Forest Bathing and Art activity in people with Dementia and Caregiver Mental Health, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Caregiver Mental Health
- What is being tested?
- Forest Bathing and Art activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Apr 2024to 17 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dementia, Caregiver Mental Health
- Being tested
- Forest Bathing, Art activity
- Keywords
- Forest bathing
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forest BathingBehavioural
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.
Art activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Forest bathing | Experimental | 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. Receives: Behavioral: Forest Bathing |
| Art activity | Active comparator | 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. Receives: Behavioral: Art activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caregiver's Care Burden measured by 12-item version of Zarit Burden Interview (ZBI-12)
Possible range: 0-48, with higher scores indicate a worse outcome
Measured: Baseline and 6 weeks
Change in Caregiver's Depressive Symptoms measured by the Depression subscale of Hospital Anxiety and Depression Scale (HADS-D)
Possible range: 0-21, with higher scores indicate a worse outcome
Measured: Baseline and 6 weeks
Change in Caregiver's Anxiety Symptoms measured by the Anxiety subscale of Hospital Anxiety and Depression Scale (HADS-A)
Possible range: 0-21, with higher scores indicate a worse outcome
Measured: Baseline and 6 weeks
Secondary outcomes (5)
Change in Caregiver's Positive Aspect of Caregiving measured by the Positive Aspect of Caregiving Scale (PACS)
Possible range: 11-55, with higher scores indicate a better outcome
Measured: Baseline and 6 weeks
Change in Caregiver's Caregiving Self-Efficacy measured by the Revised Scale for Caregiving Self-Efficacy (CSE-R)
Possible range: 0-100, with higher scores indicate a better outcome
Measured: 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)
Possible range: 0-100, with higher scores indicate a better outcome
Measured: Baseline and 6 weeks
Change in Neuropsychiatric Symptoms of Person Living with Dementia measured by the Neuropsychiatric Inventory - Questionnaire (NPI-Q)
Possible range: 0-12, with higher scores indicate a worse outcome
Measured: 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)
Possible range: 0-100, with higher scores indicate a better outcome
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start22 Apr 2024
- Primary completion17 Aug 2024
- Study completion17 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Young Women's Christian Association
- Responsible party
- Principal investigator, Choy Chak Pui Jacky, The University of Hong Kong
- Investigators
- Chak Pui Jacky Choy, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813196
- Sponsor's protocol ID
- EA240180
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forest Bathing Intervention for Persons Living with Dementia and Family Carers: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06813196
- Acronym / sponsor ID
- EA240180
- Conditions
- Dementia, Caregiver Mental Health
- Keywords
- Forest bathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Young Women's Christian Association
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 17 Aug 2024 (actual)
- First posted
- 6 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forest bathing | Experimental | Behavioral: Forest BathingThe 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. |
| Art activity | Active comparator | Behavioral: Art activityThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Forest BathingForest 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. | Behavioural | Forest bathing |
| Art activityArt 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. | Behavioural | Art activity |
Primary outcome
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
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
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
5 secondary outcomes
Change in Caregiver's Positive Aspect of Caregiving measured by the Positive Aspect of Caregiving Scale (PACS)
Time frame: 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
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
Change in Neuropsychiatric Symptoms of Person Living with Dementia measured by the Neuropsychiatric Inventory - Questionnaire (NPI-Q)
Time frame: 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
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 10 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Chak Pui Jacky Choy, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forest Bathing and Art activity in people with Dementia and Caregiver Mental Health, 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 4 inclusion and 3 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 10 Feb 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?
Change in Caregiver's Care Burden measured by 12-item version of Zarit Burden Interview (ZBI-12) (time frame: Baseline and 6 weeks). The study lists 3 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 10 Feb 2025.