Clinical trial NCT06601920: A Study of Activity Leader to Forest Therapy Campaign in Different Environments Targets on the Participants Which Had Been Infected by SARS-COV-2
Official title: A Study of Activity Leader to Forest Therapy Campaign in Different Environments Targets on the Participants Which Had Been Infected by SARS-COV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Forestry Research Institute, Ministry of Agriculture, Taiwan
First posted: 2024-09-19
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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. 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. 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.

Participants who have been diagnosed with the new coronavirus will be recived two hours of guided forest healing activities or self-guided forest healing activities.

Detailed description: In response to the psychosocial conditions arising from the ongoing pandemic, forest healing offers a corresponding solution. Forest healing activities have shown good adaptability in addressing conditions such as depression and anxiety. A systematic big data analysis paper highlights a significant decrease in depression following forest healing, with a Test overall effect Z=-6.204, as well as a similar significant reduction in anxiety with a Test overall effect Z=-4.183 (Yeon et al., 2021). For urban dwellers, a systematic review of big data on healing activities conducted in forest environments demonstrates significant normalization of systolic and diastolic blood pressure, an increase in the parasympathetic-to-sympathetic nervous system ratio, and a reduction in salivary cortisol concentration, with blood pressure shifting closer to normal indicators and salivary cortisol levels showing a downward trend after activities (Park et al., 2010; Qiu et al., 2022). Among populations exposed to chronic stressors, cortisol levels are higher compared to normal groups (Miller et al., 2007), and elevated salivary amylase activity is also noted compared to control groups (Vineetha et al., 2014). Therefore, forest healing significantly improves conditions like anxiety and depression, as reflected in the reduction of salivary cortisol concentrations.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Profile of Mood States 2nd Edition-Adult Short, POMS
timeFrame: Before and after the two-hour forest healing activity
measure: The Beck Anxiety Inventory, BAI
timeFrame: Before the two-hour forest healing activity and again 7 days afterward.
measure: The Beck Depression In- ventory-Second edition, BDI-II
timeFrame: Before the two-hour forest healing activity and again 14 days afterward.
measure: The brief World Health Organization Quality of Life, WHOQOL-BREF
timeFrame: Before the two-hour forest healing activity and again 28 days afterward.
measure: Fear of COVID-19 Scale, FCV-19S
timeFrame: Before the two-hour forest healing activity and again 28 days afterward.
measure: Salivary Amylase Enzyme Activity
timeFrame: Before and after the two-hour forest healing activity
measure: Salivary Cortisol Concentration
timeFrame: Before and after the two-hour forest healing activity
Secondary outcomes:
measure: Post-COVID Functional Status, PCFS
timeFrame: Before the two-hour forest healing activity and again 28 days afterward.
measure: Blood pressure, Heart rate, and Heart rate variability
timeFrame: Before and after the two-hour forest healing activity
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Branch of Linsen Chinese Medicine and Kunming, Taipei City Hospital
Study officials:
affiliation: Branch of Linsen Chinese Medicine and Kunming, Taipei City Hospital
name: Chung-Hua Hsu, MD., PhD.
role: STUDY_CHAIR
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