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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, Hong Kong
        • The University of Hong Kong

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Forest Bathing
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.
Behavioral: Art activity
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hong Kong Young Women's Christian Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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