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

NCT ID: NCT05827692

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-13
• Study Completion Date: 2023-12-01

Brief 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.

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).

Conditions

Psychological Well-being

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention group A

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Intervention group A

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Autonoma de Barcelona

OTHER

Sponsor Role: collaborator

Laura Comendador-Vazquez

OTHER

Sponsor Role: lead

Responsible Party

Laura Comendador-Vazquez

Psychologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Laura Comendador Vázquez

Role: PRINCIPAL_INVESTIGATOR

Corporacion Parc Tauli

Locations

Coloma Moreno Quiroga

Sabadell, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Laura Comendador Vazquez

Role: CONTACT

Laura.Comendador@uab.cat

622054658

Facility Contacts

Coloma Moreno Quiroga

Role: primary

CMoreno@tauli.cat

Other Identifiers

2022/3020

Identifier Type: -

Identifier Source: org_study_id