NCT06813196

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

January 27, 2025

Last Update Submit

February 5, 2025

Conditions

Keywords

Forest bathing

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    Baseline and 6 weeks

Secondary Outcomes (5)

  • Change in Caregiver's Positive Aspect of Caregiving measured by the Positive Aspect of Caregiving Scale (PACS)

    Baseline and 6 weeks

  • Change in Caregiver's Caregiving Self-Efficacy measured by the Revised Scale for Caregiving Self-Efficacy (CSE-R)

    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)

    Baseline and 6 weeks

  • Change in Neuropsychiatric Symptoms of Person Living with Dementia measured by the Neuropsychiatric Inventory - Questionnaire (NPI-Q)

    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)

    Baseline and 6 weeks

Study Arms (2)

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.

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.

Behavioral: Art activity

Interventions

Forest BathingBEHAVIORAL

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.

Forest bathing
Art activityBEHAVIORAL

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.

Art activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Dementia

Interventions

Forest Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Relaxation TherapyMind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Chak Pui Jacky Choy, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 6, 2025

Study Start

April 22, 2024

Primary Completion

August 17, 2024

Study Completion

August 17, 2024

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations