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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychological Well-being
• Intervention / Treatment: Behavioral: Intervention group A

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Comendador Vazquez; Phone Number: 622054658; Email: Laura.Comendador@uab.cat

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08206
      • Recruiting
      • Coloma Moreno Quiroga
      • Contact: Coloma Moreno Quiroga; Email: CMoreno@tauli.cat
      • Principal Investigator: Laura Comendador Vazquez
      • Sub-Investigator: Antoni Sanz Ruiz, PhD
      • Sub-Investigator: Corel Mateo Canedo
      • Sub-Investigator: Neus Crespo Puig
      • Sub-Investigator: Miquel Cirera i Perich, PhD
      • Sub-Investigator: Eva Sanchez Perez
      • Sub-Investigator: Maria Paola Jimenez Villamizar
      • Sub-Investigator: Marta Korniyenko Korzhylova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Forest Bath Intervention group A; 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; 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.
Experimental: Forest Bath Intervention group B; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Laura Comendador-Vazquez
• Collaborators: Universitat Autonoma de Barcelona
• Investigators: Principal Investigator: Laura Comendador Vázquez, Corporación Parc Taulí

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Anticipated): June 18, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: RCT; psychological well-being; outdoor therapy; forest bath
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2022/3020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No