Back to resultsSelf-help Forest Bathing (Shinrin-yoku) on Depression, Anxiety, and Stress
Primary Purpose
Depression, Anxiety, Stress
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-help Forest Bathing
Sponsored by
About this trial
This is an interventional treatment trial for Depression, Anxiety focused on measuring Lifestyle medicine, Randomised controlled trial, Depression, Stress, Anxiety
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Self-help Forest Bathing Group
Wait List Group
Arm Description
Participants in the FB group will perform forest bathing activity at the Chinese University of Hong Kong for two session.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
Change in the Perceived Stress Scale (PSS)
The PSS, a 10-item questionnaire measuring the perceived degree of stress across situations over the past month. Items include how unpredictable, uncontrollable, and overloaded do the respondents perceive. The score ranges from "0" (never) to "4" (very often).
Change in the Insomnia Severity Index (ISI)
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Change in the The World Health Organisation- Five Well-Being Index (WHO-5)
WHO-5 is a short and generic global rating scale measuring subjective well-being.
Change in the Sheehan Disability Scale (SDS)
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
Change in the Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. Specific wording referencing "anxiety" was changed to refer to "depression".
Change in the Treatment Acceptability and Adherence Scale (TAAS)
TAAS is a self-reported, ten-item questionnaire that is rated by a seven-point Likert scale from 1 to 7, and it aims at evaluating the clients' attitude toward the treatment sessions by four domains, including acceptability, adherence, drop-out, and distress. Specific wording referencing "anxiety" was changed to refer to "depression".
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
A preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality. The SF-6D index, scored from 0.0 (worst health state) to 1.0 (best health state)
Full Information
NCT ID
NCT05743920
First Posted
February 16, 2023
Last Updated
February 16, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05743920
Brief Title
Self-help Forest Bathing (Shinrin-yoku) on Depression, Anxiety, and Stress
Official Title
Efficacy of Self-help Forest Bathing (Shinrin-yoku) on Depression, Anxiety, and Stress: A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Stress
Keywords
Lifestyle medicine, Randomised controlled trial, Depression, Stress, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-help Forest Bathing Group
Arm Type
Experimental
Arm Description
Participants in the FB group will perform forest bathing activity at the Chinese University of Hong Kong for two session.
Arm Title
Wait List Group
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Self-help Forest Bathing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
Baseline, immediate post-treatment, and 1-month follow-up
Secondary Outcome Measure Information:
Title
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Description
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
Time Frame
Baseline, immediate post-treatment, and 1-month follow-up
Title
Change in the Perceived Stress Scale (PSS)
Description
The PSS, a 10-item questionnaire measuring the perceived degree of stress across situations over the past month. Items include how unpredictable, uncontrollable, and overloaded do the respondents perceive. The score ranges from "0" (never) to "4" (very often).
Time Frame
Baseline, immediate post-treatment, and 1-month follow-up
Title
Change in the Insomnia Severity Index (ISI)
Description
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Time Frame
Baseline, immediate post-treatment, and 1-month follow-up
Title
Change in the The World Health Organisation- Five Well-Being Index (WHO-5)
Description
WHO-5 is a short and generic global rating scale measuring subjective well-being.
Time Frame
Baseline, immediate post-treatment, and 1-month follow-up
Title
Change in the Sheehan Disability Scale (SDS)
Description
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
Time Frame
Baseline, immediate post-treatment, and 1-month follow-up
Title
Change in the Credibility-Expectancy Questionnaire (CEQ)
Description
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. Specific wording referencing "anxiety" was changed to refer to "depression".
Time Frame
Baseline and immediate post-treatment
Title
Change in the Treatment Acceptability and Adherence Scale (TAAS)
Description
TAAS is a self-reported, ten-item questionnaire that is rated by a seven-point Likert scale from 1 to 7, and it aims at evaluating the clients' attitude toward the treatment sessions by four domains, including acceptability, adherence, drop-out, and distress. Specific wording referencing "anxiety" was changed to refer to "depression".
Time Frame
Baseline and immediate post-treatment
Title
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Description
A preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality. The SF-6D index, scored from 0.0 (worst health state) to 1.0 (best health state)
Time Frame
Baseline, immediate post-treatment, and 1-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Man Ho, MA in Psychology
Phone
852-39436575
Email
1155016857@link.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fiona Yan-Yee Ho
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Self-help Forest Bathing (Shinrin-yoku) on Depression, Anxiety, and Stress
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