Post COVID-19 SyndromeNCT06601920
A Study of Activity Leader to Forest Therapy Campaign in Different Environments Targets on the Participants Which Had Been Infected by SARS-COV-2
A study testing Forest healing activities in people with Post COVID-19 Syndrome and Stress Disorders, run by Taipei City Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post COVID-19 Syndrome, Stress Disorders, Life Quality
- What is being tested?
- Forest healing activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Feb 2023to 17 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Branch of Linsen Chinese Medicine and Kunming, Taipei City Hospital
Taipei
About this study
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:
- 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.
- 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.
Read the 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.
- Being tested
- Forest healing activities
- 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
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forest healing activitiesBehavioural
Also called Forest therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Forest healing activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and after the two-hour forest healing activity
Secondary outcomes (2)
Post-COVID Functional Status, PCFS
The PCFS (Post-COVID Functional Status) is a single-item functional assessment scale used to evaluate the impact on daily life following a COVID-19 diagnosis. The scale consists of only one question, with scores ranging from 0 to 4, and a minimum scale difference of 1 point.
Measured: Before the two-hour forest healing activity and again 28 days afterward.
Blood pressure, Heart rate, and Heart rate variability
ANSWatch TS-0411 Heart Rate Master Wrist Physiological Monitor: This objective assessment tool measures indicators such as blood pressure, heart rate, and heart rate variability (HRV), providing insights into the participant\'s autonomic nervous system stability. The Heart Rate Master Wrist Physiological Monitor is a non-invasive, wearable electronic device. It is worn on the wrist and automatically takes measurements once powered on. The participant should sit or lie down, and the measurement process takes approximately 6-7 minutes to complete.
Measured: Before and after the two-hour forest healing activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Feb 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Post COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- Forestry Research Institute, Ministry of Agriculture, Taiwan
- Responsible party
- Principal investigator, Chung-Hua Hsu, Taipei City Hospital
- Investigators
- Chung-Hua Hsu, MD., PhD., Study chair, Branch of Linsen Chinese Medicine and Kunming, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601920
- Sponsor's protocol ID
- TCHIRB-11112011
- Other IDs
- 112A040-04
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We undecided to share individual participant data (IPD) from this study. This decision is based on several factors: 1. Privacy and Confidentiality: Protecting participant privacy is a priority, and sharing IPD could potentially compromise confidentiality despite de-identification efforts. 2. Consent Limitations: The consent obtained from participants does not include provisions for sharing their individual data. We have not sought additional consent for data sharing. 3. Data Security: Ensuring the security of sensitive personal data is challenging, and we do not have the resources to implement the necessary measures for secure data sharing. While we acknowledge the potential benefits of IPD sharing for advancing research, these considerations necessitate our current decision. We remain committed to adhering to ethical standards and protecting participant privacy.
Publications
Yue Y, Li L, Liu R, Zhang Y, Zhang S, Sang H, Tang M, Zou T, Shah SM, Shen X, Chen J, Wu A, Jiang W, Yuan Y. The dynamic changes of psychosomatic symptoms in three waves of COVID-19 outbreak and fatigue caused by enduring pandemic in China. J Affect Disord. 2023 Jun 15;331:17-24. doi: 10.1016/j.jad.2023.03.032. Epub 2023 Mar 18.
PubMed 36934851Yeon 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.
PubMed 34886407Voitsidis 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.
PubMed 33216444Vineetha R, Pai KM, Vengal M, Gopalakrishna K, Narayanakurup D. Usefulness of salivary alpha amylase as a biomarker of chronic stress and stress related oral mucosal changes - a pilot study. J Clin Exp Dent. 2014 Apr 1;6(2):e132-7. doi: 10.4317/jced.51355. eCollection 2014 Apr.
PubMed 24790712Qiu 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.
PubMed 36612777Park 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.
PubMed 19568835Lam ICH, Wong CKH, Zhang R, Chui CSL, Lai FTT, Li X, Chan EWY, Luo H, Zhang Q, Man KKC, Cheung BMY, Tang SCW, Lau CS, Wan EYF, Wong ICK. Long-term post-acute sequelae of COVID-19 infection: a retrospective, multi-database cohort study in Hong Kong and the UK. EClinicalMedicine. 2023 Jun;60:102000. doi: 10.1016/j.eclinm.2023.102000. Epub 2023 May 11.
PubMed 37197226Labrague LJ, de Los Santos JAA. Fear of COVID-19, psychological distress, work satisfaction and turnover intention among frontline nurses. J Nurs Manag. 2021 Apr;29(3):395-403. doi: 10.1111/jonm.13168. Epub 2020 Oct 11.
PubMed 32985046Kim 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.
PubMed 34209647Han Q, Zheng B, Agostini M, Belanger JJ, Gutzkow B, Kreienkamp J, Reitsema AM, van Breen JA, Collaboration P, Leander NP. Associations of risk perception of COVID-19 with emotion and mental health during the pandemic. J Affect Disord. 2021 Apr 1;284:247-255. doi: 10.1016/j.jad.2021.01.049. Epub 2021 Jan 26.
PubMed 33602537Dye C. Health and urban living. Science. 2008 Feb 8;319(5864):766-9. doi: 10.1126/science.1150198.
PubMed 18258905
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06601920
- Acronym / sponsor ID
- TCHIRB-11112011
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- Forestry Research Institute, Ministry of Agriculture, Taiwan
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Guided and then self-guided in Taipei Botanical Garden | Experimental | Behavioral: Forest healing activitiesOne 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. |
| Self-guided and then guided in Taipei Botanical Garden | Experimental | Behavioral: Forest healing activitiesOne 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. |
| Guided and then self-guided in Chiayi Arboretum. | Experimental | Behavioral: Forest healing activitiesOne 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. |
| Self-guided and then guided in Chiayi Arboretum | Experimental | Behavioral: Forest healing activitiesOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forest healing activitiesAlso: Forest therapyThe 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. | Behavioural | 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 |
Primary outcome
Profile of Mood States 2nd Edition-Adult Short, POMS
Time frame: Before and after the two-hour forest healing activity
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.
The Beck Anxiety Inventory, BAI
Time frame: Before the two-hour forest healing activity and again 7 days afterward.
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.
The Beck Depression In- ventory-Second edition, BDI-II
Time frame: Before the two-hour forest healing activity and again 14 days afterward.
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.
The brief World Health Organization Quality of Life, WHOQOL-BREF
Time frame: Before the two-hour forest healing activity and again 28 days afterward.
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.
Fear of COVID-19 Scale, FCV-19S
Time frame: Before the two-hour forest healing activity and again 28 days afterward.
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.
Salivary Amylase Enzyme Activity
Time frame: Before and after the two-hour forest healing 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.
Salivary Cortisol Concentration
Time frame: Before and after the two-hour forest healing activity
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.
2 secondary outcomes
Post-COVID Functional Status, PCFS
Time frame: Before the two-hour forest healing activity and again 28 days afterward.
Blood pressure, Heart rate, and Heart rate variability
Time frame: Before and after the two-hour forest healing activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 36934851Yue Y, Li L, Liu R, Zhang Y, Zhang S, Sang H, Tang M, Zou T, Shah SM, Shen X, Chen J, Wu A, Jiang W, Yuan Y. The dynamic changes of psychosomatic symptoms in three waves of COVID-19 outbreak and fatigue caused by enduring pandemic in China. J Affect Disord. 2023 Jun 15;331:17-24. doi: 10.1016/j.jad.2023.03.032. Epub 2023 Mar 18.
- Results publication: PubMed 34886407Yeon 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.
- Results publication: PubMed 33216444Voitsidis 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.
- Results publication: PubMed 24790712Vineetha R, Pai KM, Vengal M, Gopalakrishna K, Narayanakurup D. Usefulness of salivary alpha amylase as a biomarker of chronic stress and stress related oral mucosal changes - a pilot study. J Clin Exp Dent. 2014 Apr 1;6(2):e132-7. doi: 10.4317/jced.51355. eCollection 2014 Apr.
- Results publication: PubMed 36612777Qiu 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.
- Results publication: PubMed 19568835Park 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.
- Results publication: PubMed 37197226Lam ICH, Wong CKH, Zhang R, Chui CSL, Lai FTT, Li X, Chan EWY, Luo H, Zhang Q, Man KKC, Cheung BMY, Tang SCW, Lau CS, Wan EYF, Wong ICK. Long-term post-acute sequelae of COVID-19 infection: a retrospective, multi-database cohort study in Hong Kong and the UK. EClinicalMedicine. 2023 Jun;60:102000. doi: 10.1016/j.eclinm.2023.102000. Epub 2023 May 11.
- Results publication: PubMed 32985046Labrague LJ, de Los Santos JAA. Fear of COVID-19, psychological distress, work satisfaction and turnover intention among frontline nurses. J Nurs Manag. 2021 Apr;29(3):395-403. doi: 10.1111/jonm.13168. Epub 2020 Oct 11.
- Results publication: PubMed 34209647Kim 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.
- Results publication: PubMed 33602537Han Q, Zheng B, Agostini M, Belanger JJ, Gutzkow B, Kreienkamp J, Reitsema AM, van Breen JA, Collaboration P, Leander NP. Associations of risk perception of COVID-19 with emotion and mental health during the pandemic. J Affect Disord. 2021 Apr 1;284:247-255. doi: 10.1016/j.jad.2021.01.049. Epub 2021 Jan 26.
- Results publication: PubMed 18258905Dye C. Health and urban living. Science. 2008 Feb 8;319(5864):766-9. doi: 10.1126/science.1150198.
- Individual participant dataSharing planned: Undecided. We undecided to share individual participant data (IPD) from this study. This decision is based on several factors: 1. Privacy and Confidentiality: Protecting participant privacy is a priority, and sharing IPD could potentially compromise confidentiality despite de-identification efforts. 2. Consent Limitations: The consent obtained from participants does not include provisions for sharing their individual data. We have not sought additional consent for data sharing. 3. Data Security: Ensuring the security of sensitive personal data is challenging, and we do not have the resources to implement the necessary measures for secure data sharing. While we acknowledge the potential benefits of IPD sharing for advancing research, these considerations necessitate our current decision. We remain committed to adhering to ethical standards and protecting participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Hua Hsu, MD., PhD. study chair
Branch of Linsen Chinese Medicine and Kunming, Taipei City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forest healing activities in people with Post COVID-19 Syndrome and Stress Disorders, run by Taipei City Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of Mood States 2nd Edition-Adult Short, POMS (time frame: Before and after the two-hour forest healing activity). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06601920, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.