A Study of Activity Leader to Forest Therapy Campaign in Different Environments Targets on the Participants Which Had Been Infected by SARS-COV-2

NCT06601920 | Completed

• 2 other identifiers: TCHIRB-11112011112A040-04
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the impact of self-guided forest healing activities and guided forest healing activities on the reduction of psychological stress inindividuals diagnosed with the new coronavirus. The main questions aim to answer are:

1. 1.Effectiveness of Forest Healing Activities on Emotional Well-being: Researchers will compare the emotional improvement effects between self-guided and guided forest healing activities to determine their effectiveness.
2. 2.Comparison of Healing Effects in Different Locations: Researchers will compare the effects of forest healing activities conducted in two similar environments, the Taipei Botanical Garden and the Chiayi Arboretum, to assess whether location influences outcomes despite similar altitude and latitude.

Conditions

Post COVID-19 Syndrome; Stress Disorders; Life Quality; Depression Anxiety Disorder

Keywords

Post COVID-19 syndrome; Profile of Mood States 2nd Edition-Adult Short,POMS; The Beck Depression In- ventory-Second edition, BDI-II; The Beck Anxiety Inventory, BAI; WHOQOL-BREF

Outcome Measures

Primary Outcomes (7)

• Profile of Mood States 2nd Edition-Adult Short, POMS

  The POMS (Profile of Mood States) is an indicator of both negative and positive emotions. It is divided into measures of positive social interaction (Friendliness), positive emotion scores, and negative emotion scores. A higher total POMS mood disturbance score (POMSTMD) indicates that negative emotions outweigh positive ones, while a lower score indicates the opposite. POMS contains 35 emotional adjectives, and participants select the option that best describes their emotional state for each adjective. The response options are: not at all, moderately, and extremely, scored from 0 to 4, respectively. The total score is calculated by subtracting the positive emotion Vigor score from the sum of the negative emotion subscale scores. Subscale scores range from 0 to 20, and the total score ranges from -20 to 100, with a minimum scale difference of 1 point.

  Before and after the two-hour forest healing activity

• The Beck Anxiety Inventory, BAI

  The BAI (Beck Anxiety Inventory) is a self-assessed anxiety scale developed by the research team at the Center for Cognitive Therapy, Department of Psychiatry, University of Pennsylvania School of Medicine. It asks participants to rate their level of distress for 21 anxiety-related symptoms. The response options are: not at all, mildly, moderately, and severely, with scores ranging from 0 to 3. The scale consists of 21 items, with each item scored from 0 to 3. The total score ranges from 0 to 63, with a minimum scale difference of 1 point. Scores of 0-7 indicate minimal anxiety, 8-15 indicate mild anxiety, 16-25 indicate moderate anxiety, and 26-63 indicate severe anxiety.

  Before the two-hour forest healing activity and again 7 days afterward.

• The Beck Depression In- ventory-Second edition, BDI-II

  The BAI (Beck Anxiety Inventory) is a self-assessed anxiety scale developed by the research team at the Center for Cognitive Therapy, Department of Psychiatry, University of Pennsylvania School of Medicine. It asks participants to rate their level of distress for 21 anxiety-related symptoms. The response options are: not at all, mildly, moderately, and severely, with scores ranging from 0 to 3. The scale consists of 21 items, with each item scored from 0 to 3. The total score ranges from 0 to 63, with a minimum scale difference of 1 point. Scores of 0-7 indicate minimal anxiety, 8-15 indicate mild anxiety, 16-25 indicate moderate anxiety, and 26-63 indicate severe anxiety.

  Before the two-hour forest healing activity and again 14 days afterward.

• The brief World Health Organization Quality of Life, WHOQOL-BREF

  The WHOQOL-BREF is the abbreviated version of the World Health Organization Quality of Life Questionnaire (WHOQOL-100), which defines quality of life as an individual\'s perception of their position in life within the context of the cultural value systems in which they live. This perception is related to six main areas: physical health, psychological state, level of independence, social relationships, personal beliefs, and environment. These are broken down into 24 facets, with each facet represented by one question. Additionally, two Taiwan-specific questions are included, forming the Taiwan abbreviated version of the questionnaire, which measures overall quality of life. The scale consists of 28 items, with higher scores indicating better quality of life. Each item is originally scored on a scale from 0 to 1, with a total score range of 0 to 28, and the minimum scale difference being 0.25 points.

  Before the two-hour forest healing activity and again 28 days afterward.

• Fear of COVID-19 Scale, FCV-19S

  The FSV-19S consists of 7 items, measuring participants\' self-assessed fear of COVID-19. The results capture aspects of fearful thoughts, physiological reactions, and basic fears. The scale was reduced from 10 items to 7, with the items showing high intercorrelation. Responses are rated on a 5-point scale, ranging from strongly disagree, disagree, uncertain, agree, to strongly agree, scored from 1 to 5. The scale consists of 7 items, with each item scored from 1 to 5. The total score ranges from 7 to 35, with a minimum scale difference of 1 point.

  Before the two-hour forest healing activity and again 28 days afterward.

• Salivary Amylase Enzyme Activity

  Participants are required to collect saliva samples in microcentrifuge tubes with a capacity of at least 0.5 to 1.5 milliliters. Salivary Amylase Enzyme Activity Measurement: This is conducted using the SALIMETRICS® SALIVARY α-AMYLASE KINETIC ENZYME ASSAY KIT (Item No. 1-1902). The kit utilizes a compound formed by the covalent bonding of 2-chloro-p-nitrophenol and maltotriose, which is first hydrolyzed in a 96-well plate to produce maltotriose and 2-chloro-p-nitrophenol. The α-amylase in the saliva sample then converts 2-chloro-4-nitrophenylmaltoside into a product with an absorbance peak at 405 nm. The rate of this conversion determines the α-amylase activity.

  Before and after the two-hour forest healing activity

• Salivary Cortisol Concentration

  Participants are required to collect saliva samples in microcentrifuge tubes with a capacity of at least 0.5 to 1.5 milliliters. Salivary Cortisol Concentration Measurement: This is performed using the SALIMETRICS® Expanded Range High Sensitivity SALIVARY CORTISOL ENZYME IMMUNOASSAY KIT (Item No. 1-3002). The assay involves an enzyme-linked immunoassay with a four-parameter logistic model for calculation. Absorbance is read at a wavelength of 450 nm, with 490-492 nm used as a two-point calibration range. A higher reading corresponds to a lower concentration. The Salimetrics® kit includes a complete set of standards to minimize preparation errors.

  Before and after the two-hour forest healing activity

Secondary Outcomes (2)

• Post-COVID Functional Status, PCFS

  Before the two-hour forest healing activity and again 28 days afterward.

• Blood pressure, Heart rate, and Heart rate variability

  Before and after the two-hour forest healing activity

Study Arms (4)

Guided and then self-guided in Taipei Botanical Garden

EXPERIMENTAL

One group will get guided forest healing activities during the first period of the trial, and then self-guided during the second period in Taipei Botanical Garden.

Behavioral: Forest healing activities

Self-guided and then guided in Taipei Botanical Garden

EXPERIMENTAL

One group will get "self-guided healing activities" during the first period of the trial, and then "guided forest healing activities" during the second period in Taipei Botanical Garden.

Behavioral: Forest healing activities

Guided and then self-guided in Chiayi Arboretum.

EXPERIMENTAL

One group will get "guided forest healing activities" during the first period of the trial, and then "self-guided healing activities" during the second period in Chiayi Arboretum.

Behavioral: Forest healing activities

Self-guided and then guided in Chiayi Arboretum

EXPERIMENTAL

One group will get "self-guided healing activities" during the first period of the trial, and then "guided forest healing activities" during the second period in Chiayi Arboretum.

Behavioral: Forest healing activities

Interventions

Forest healing activities BEHAVIORAL

The two-hour forest healing activity, led by horticultural therapists from the Taiwan Horticultural Therapy Association, includes activities such as leaf stacking on stones, listening to sounds with closed eyes, body stretching, blindfolded tree identification, \"my tree friend,\" earth mandala creation, tea tasting, and sharing of reflections.

Also known as: Forest therapy

Guided and then self-guided in Chiayi Arboretum.; Guided and then self-guided in Taipei Botanical Garden; Self-guided and then guided in Chiayi Arboretum; Self-guided and then guided in Taipei Botanical Garden

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who have been diagnosed with COVID-19 (SARS-CoV-2) and have completed their isolation.
• Participants aged 18 years or older who voluntarily agree to participate in the study.

You may not qualify if:

• Individuals who do not have the capability and stamina to walk for more than 120 minutes.
• Current smokers, betel nut chewers, or individuals who consume alcohol (more than five standard drinks in any situation).
• Individuals with a history of substance addiction (including both narcotic and non-narcotic drugs).
• Participants currently involved in another clinical trial or undergoing an intervention trial follow-up.
• Pregnant or breastfeeding women.
• Situations where participants are unable to cooperate (e.g., inability to participate after random assignment or refusal to sign the informed consent form).

Sponsors & Collaborators

• Taipei City Hospital: lead
• Forestry Research Institute, Ministry of Agriculture, Taiwan: collaborator

Study Sites (1)

Branch of Linsen Chinese Medicine and Kunming, Taipei City Hospital

Taipei, Taiwan

Location

Related Publications (11)

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  PMID: 36934851 BACKGROUND

• Yeon PS, Jeon JY, Jung MS, Min GM, Kim GY, Han KM, Shin MJ, Jo SH, Kim JG, Shin WS. Effect of Forest Therapy on Depression and Anxiety: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Dec 1;18(23):12685. doi: 10.3390/ijerph182312685.

  PMID: 34886407 BACKGROUND

• Voitsidis P, Nikopoulou VA, Holeva V, Parlapani E, Sereslis K, Tsipropoulou V, Karamouzi P, Giazkoulidou A, Tsopaneli N, Diakogiannis I. The mediating role of fear of COVID-19 in the relationship between intolerance of uncertainty and depression. Psychol Psychother. 2021 Sep;94(3):884-893. doi: 10.1111/papt.12315. Epub 2020 Nov 20.

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• Qiu Q, Yang L, He M, Gao W, Mar H, Li J, Wang G. The Effects of Forest Therapy on the Blood Pressure and Salivary Cortisol Levels of Urban Residents: A Meta-Analysis. Int J Environ Res Public Health. 2022 Dec 27;20(1):458. doi: 10.3390/ijerph20010458.

  PMID: 36612777 BACKGROUND

• Park BJ, Tsunetsugu Y, Kasetani T, Kagawa T, Miyazaki Y. The physiological effects of Shinrin-yoku (taking in the forest atmosphere or forest bathing): evidence from field experiments in 24 forests across Japan. Environ Health Prev Med. 2010 Jan;15(1):18-26. doi: 10.1007/s12199-009-0086-9.

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  PMID: 32985046 BACKGROUND

• Kim JG, Shin WS. Forest Therapy Alone or with a Guide: Is There a Difference between Self-Guided Forest Therapy and Guided Forest Therapy Programs? Int J Environ Res Public Health. 2021 Jun 29;18(13):6957. doi: 10.3390/ijerph18136957.

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  PMID: 18258905 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Stress Disorders, Traumatic

Interventions

Forest Therapy

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Relaxation Therapy; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Chung-Hua Hsu, MD., PhD.

  Branch of Linsen Chinese Medicine and Kunming, Taipei City Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Superintendent, Branch of Linsen Chinese Medicine and Kunming, Taipei City Hospital

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: February 27, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TW (1)