NCT05743920

Brief Summary

The objective of this pilot randomized controlled trial is to evaluate the efficacy and acceptability of self-help forest bathing on depression, anxiety, and stress in the Hong Kong adult population. Prior to all study procedures, eligible participants will be required to complete an online informed consent form (with telephone support). Around 80 eligible participants aged between 18 to 65 years old with at least a mild level of depression, anxiety, or stress symptoms will be randomly assigned to either the self-help forest bathing intervention group (FB group) or the waitlist control group (WL group) in a ratio of 1:1. Participants in the FB group will receive forest bathing guidance via an in-house smartphone app. The WL group will be asked to maintain their typical activity in week 1-7. This group will receive the guide upon trial completion in week 8. The outcomes of the interest will include generalized anxiety symptoms, depressive symptoms, insomnia symptoms, wellbeing, health-related quality of life, functional impairment at baseline (week 0), immediate (week 7), and 1-month post-intervention assessments (week 10). Treatment credibility and acceptability will be collected at baseline and immediately after the intervention.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

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

February 1, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

February 16, 2023

Last Update Submit

February 16, 2023

Conditions

Keywords

Lifestyle medicineRandomised controlled trialDepressionStressAnxiety

Outcome Measures

Primary Outcomes (1)

  • Change in the Patient Health Questionnaire (PHQ-9)

    The PHQ-9, a 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).

    Baseline, immediate post-treatment, and 1-month follow-up

Secondary Outcomes (8)

  • Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)

    Baseline, immediate post-treatment, and 1-month follow-up

  • Change in the Perceived Stress Scale (PSS)

    Baseline, immediate post-treatment, and 1-month follow-up

  • Change in the Insomnia Severity Index (ISI)

    Baseline, immediate post-treatment, and 1-month follow-up

  • Change in the The World Health Organisation- Five Well-Being Index (WHO-5)

    Baseline, immediate post-treatment, and 1-month follow-up

  • Change in the Sheehan Disability Scale (SDS)

    Baseline, immediate post-treatment, and 1-month follow-up

  • +3 more secondary outcomes

Study Arms (2)

Self-help Forest Bathing Group

EXPERIMENTAL

Participants in the FB group will perform forest bathing activity at the Chinese University of Hong Kong for two session.

Behavioral: Self-help Forest Bathing

Wait List Group

OTHER
Behavioral: Self-help Forest Bathing

Interventions

The self-help forest bathing includes two sessions (i.e., participants will perform the first intervention within week 1 to 3, and the second intervention within week 4 to 6) that are related to the following forest bathing activities : (a) forest meditation, (b) forest walking, (c) calling attention to sensory experiences of the forest, including seeing, hearing, touching, and smelling, and (d) building connection to the nature by partnership invitation. Each session will last for 45 minutes.

Self-help Forest Bathing GroupWait List Group

Eligibility Criteria

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

You may qualify if:

  • Hong Kong residents;
  • Aged between 18 to 65 years;
  • Meet the threshold for mild depression (score of \>5 on the Patient Health Questionnaire 9 \[PHQ-9\], anxiety (\>5 Generalized Anxiety Disorder 7 \[GAD-7\]), or stress (\>15 on the Depression, Anxiety, and Stress Scale \[DASS-21\] stress subscale, after multiplying score by 2);
  • Able to read and understand Chinese and type in Chinese or English
  • Have an Internet-enabled mobile device (iOS or Android operating system)
  • Willing to provide informed consent and comply with the trial protocol

You may not qualify if:

  • Received psychotherapy for depression, anxiety and stress in the past 6 months;
  • A change in psychotropic drugs or over-the-counter medications that target depression, anxiety, and stress within 2 weeks before the baseline assessment.
  • Patient Health Questionnaire-9 (PHQ-9) item 9 score \> 2, indicating a moderate level of suicidal risk that requires active crisis management (referral information to professional mental health services will be provided);
  • Currently participating in another intervention study that may potentially affect mental health;
  • Self-disclosure of having unsafe health conditions for which physical activity was contraindicated by physicians;
  • Self-disclosure of any psychiatric, medical, or neurocognitive disorder(s) that makes participation unfeasible;
  • Pregnancy;
  • Hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Fiona Yan-Yee Ho

    Chinese University of Hong Kong

    STUDY CHAIR

Central Study Contacts

Ka Man Ho, MA in Psychology

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 24, 2023

Study Start

February 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share