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

Primary Purpose

Psychological Well-being

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention group A
Sponsored by
Laura Comendador-Vazquez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychological Well-being focused on measuring forest bath, outdoor therapy, psychological well-being, RCT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Coloma Moreno QuirogaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Forest Bath Intervention group A

Forest Bath Intervention group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Anxiety scores
Generalized Anxiety Scale (GAD-7).
Change in Depression scores
Patient Health Questionnaire (PHQ-9).
Change in Well-Being scores
Emotional Well-Being Scale
Change in Social support scores
OSLO Scale 3
Change in State Mindfulness scores
State Mindfulness Scale (SMS)
Change in Affect scores
Positive and Negative Affect Checklist (PANAS-SF).
Change in Mood scores
Profile of Mood States (POMS)
Change in Stress scores
Ad hoc perceived stress item
Change in Affective variables scores
Self-Assessment Manikin (SAM)

Secondary Outcome Measures

Full Information

First Posted
March 21, 2023
Last Updated
April 12, 2023
Sponsor
Laura Comendador-Vazquez
Collaborators
Universitat Autonoma de Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05827692
Brief Title
Impact of Forest Baths on Emotional Well-being in People With Sub-clinical Symptomatology of Anxiety and Depression
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
June 18, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Laura Comendador-Vazquez
Collaborators
Universitat Autonoma de Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Well-being
Keywords
forest bath, outdoor therapy, psychological well-being, RCT

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Forest Bath Intervention group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Forest Bath Intervention group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention group A
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Anxiety scores
Description
Generalized Anxiety Scale (GAD-7).
Time Frame
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.
Title
Change in Depression scores
Description
Patient Health Questionnaire (PHQ-9).
Time Frame
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.
Title
Change in Well-Being scores
Description
Emotional Well-Being Scale
Time Frame
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.
Title
Change in Social support scores
Description
OSLO Scale 3
Time Frame
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.
Title
Change in State Mindfulness scores
Description
State Mindfulness Scale (SMS)
Time Frame
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.
Title
Change in Affect scores
Description
Positive and Negative Affect Checklist (PANAS-SF).
Time Frame
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.
Title
Change in Mood scores
Description
Profile of Mood States (POMS)
Time Frame
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.
Title
Change in Stress scores
Description
Ad hoc perceived stress item
Time Frame
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.
Title
Change in Affective variables scores
Description
Self-Assessment Manikin (SAM)
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Comendador Vazquez
Phone
622054658
Email
Laura.Comendador@uab.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Comendador Vázquez
Organizational Affiliation
Corporacion Parc Tauli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coloma Moreno Quiroga
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08206
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coloma Moreno Quiroga
Email
CMoreno@tauli.cat
First Name & Middle Initial & Last Name & Degree
Laura Comendador Vazquez
First Name & Middle Initial & Last Name & Degree
Antoni Sanz Ruiz, PhD
First Name & Middle Initial & Last Name & Degree
Corel Mateo Canedo
First Name & Middle Initial & Last Name & Degree
Neus Crespo Puig
First Name & Middle Initial & Last Name & Degree
Miquel Cirera i Perich, PhD
First Name & Middle Initial & Last Name & Degree
Eva Sanchez Perez
First Name & Middle Initial & Last Name & Degree
Maria Paola Jimenez Villamizar
First Name & Middle Initial & Last Name & Degree
Marta Korniyenko Korzhylova

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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