Impact of Forest Baths on Emotional Well-being in People With Sub-clinical Symptomatology of Anxiety and Depression

Study Overview
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Brief Summary
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The investigators intend to evaluate patients aged 18 to 99 years with symptoms of anxiety and/or mild depression. A randomized controlled clinical trial will be carried out to evaluate the impact of the guided practice of forest bathing.

Detailed Description
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The practice of Shinrin-Yoku, also known as Forest Bathing, is an outdoor therapeutic modality with growing evidence suggesting positive effects on the psychological well-being and general health of individuals. However, its benefits have been studied mainly in Asian countries, needing further research to assess whether its benefits are also generalizable to other European-Mediterranean regions. To explore this question, the investigators intend to evaluate patients aged 18 to 99 years with symptoms of anxiety and/or mild depression. A randomized controlled clinical trial will be carried out to evaluate the impact of the guided practice of forest bathing. The participants will be randomly distributed in two arms, with a crossover design: arm A intervention + control; arm B control + intervention. Participation in this study consists of the execution of two sessions of guided forest bathing practice, and the completion of online evaluation forms before and after each session of guided forest bathing practice, for 24 hours afterwards, as well as before and after the program as a whole. The study includes clinical assessments, emotional well-being, social support and other complementary indicators. For hypothesis testing, a linear model of univariate analysis of variance intrasubject design will be applied to the dependent variables, with three phase conditions (pre, post and follow-up) and two treatment conditions (intervention vs. control).

Official Title
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UAB-CAN RULL 2022 Study: Impact of Forest Baths on Emotional Well-being in People With Sub-clinical Symptomatology of Anxiety and Depression

Conditions
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Psychological Well-being

Intervention / Treatment
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* Behavioral: Intervention group A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged 18 to 65 years. Voluntary signature of informed consent. Symptomatology of anxiety and/or mild depression with mild interference in daily functioning. Motivation, attitude and ability to work in a group. Receptive attitude to learning new skills and sharing experiences. Exclusion Criteria: Serious psychiatric disorder: Major depressive disorder with or without psychotic symptoms, uncompensated major depressive episode, dysthymic disorder, presence of suicidal ideation or suicide attempts, personality disorder. Lack of knowledge of Catalan and Spanish. Disconformity with acceptable standards of conduct.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a single-center randomized controlled trial with an intrasubject pre-post design. The intervention is developed by means of two crossed treatment arms: Arm A (intervention + control); Arm B (control + intervention).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Forest Bath Intervention group A<br>The intervention consists of 2 sessions of approximately 2 hours duration and fortnightly frequency. In this context, it is guaranteed that patients will receive the care, visits and treatments usually used in people who have presented their clinical situation. The only difference between participating or not in the intervention is the participation in the practice of forest baths and the performance of some additional assessments, i.e. not routinely performed, which are part of this project. The investigators will be responsible for providing an overview of the study to eligible patients interested in participating. Before proceeding to start the intervention, an informed consent will be given to the patients, in which a description of the characteristics of the sessions will be provided. | Behavioral: Intervention group A<br>* The forest bath sessions will be led by a specialized guide and will be conceived as a silent walk of about 3 km along a path and forest track with an average gradient of 3%, with three 10-minute stops (at the beginning, in the middle and at the end) to practice deep breathing and awareness of the 5 senses.<br>|
| Experimental: Forest Bath Intervention group B<br>The intervention consists of 2 sessions of approximately 2 hours duration and fortnightly frequency. In this context, it is guaranteed that patients will receive the care, visits and treatments usually used in people who have presented their clinical situation. The only difference between participating or not in the intervention is the participation in the practice of forest baths and the performance of some additional assessments, i.e. not routinely performed, which are part of this project. The investigators will be responsible for providing an overview of the study to eligible patients interested in participating. Before proceeding to start the intervention, an informed consent will be given to the patients, in which a description of the characteristics of the sessions will be provided. | Behavioral: Intervention group A<br>* The forest bath sessions will be led by a specialized guide and will be conceived as a silent walk of about 3 km along a path and forest track with an average gradient of 3%, with three 10-minute stops (at the beginning, in the middle and at the end) to practice deep breathing and awareness of the 5 senses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety scores | Generalized Anxiety Scale (GAD-7). | Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes. | 
| Change in Depression scores | Patient Health Questionnaire (PHQ-9). | Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes. | 
| Change in Well-Being scores | Emotional Well-Being Scale | Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes. | 
| Change in Social support scores | OSLO Scale 3 | Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes. | 
| Change in State Mindfulness scores | State Mindfulness Scale (SMS) | Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes. | 
| Change in Affect scores | Positive and Negative Affect Checklist (PANAS-SF). | Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes. | 
| Change in Mood scores | Profile of Mood States (POMS) | Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes. | 
| Change in Stress scores | Ad hoc perceived stress item | Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes. | 
| Change in Affective variables scores | Self-Assessment Manikin (SAM) | Pre-intervention, intrasession, intersession, post-intervention and follo-up evaluations are planned for 1 month. The assessments will be carried out before and after the intervention with a maximum duration of 45 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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forest bath, outdoor therapy, psychological well-being, RCT