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

Psychological Well-being Clinical Trial

— NAT-UAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827692
• Other study ID #: 2022/3020
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: Corporacion Parc Tauli
• Contact: Laura Comendador Vazquez
• Phone: 622054658
• Email: Laura.Comendador[@]uab.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2023
• Est. primary completion date: June 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Psychological Well-being

Intervention

Behavioral:
• Intervention group A
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.

Locations

Country	Name	City	State
Spain	Coloma Moreno Quiroga	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Laura Comendador-Vazquez	Universitat Autonoma de Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.