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

Sponsor
Laura Comendador-Vazquez (Other)
Overall Status
Recruiting
CT.gov ID
NCT05827692
Collaborator
Universitat Autonoma de Barcelona (Other)
50
1
2
14.6
3.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention group A
N/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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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).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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Sep 13, 2022
Anticipated Primary Completion Date :
Jun 18, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Anxiety scores [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.]

    Generalized Anxiety Scale (GAD-7).

  2. Change in Depression scores [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.]

    Patient Health Questionnaire (PHQ-9).

  3. Change in Well-Being scores [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.]

    Emotional Well-Being Scale

  4. Change in Social support scores [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.]

    OSLO Scale 3

  5. Change in State Mindfulness scores [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.]

    State Mindfulness Scale (SMS)

  6. Change in Affect scores [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.]

    Positive and Negative Affect Checklist (PANAS-SF).

  7. Change in Mood scores [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.]

    Profile of Mood States (POMS)

  8. Change in Stress scores [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.]

    Ad hoc perceived stress item

  9. Change in Affective variables scores [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.]

    Self-Assessment Manikin (SAM)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Coloma Moreno Quiroga Sabadell Barcelona Spain 08206

Sponsors and Collaborators

  • Laura Comendador-Vazquez
  • Universitat Autonoma de Barcelona

Investigators

  • Principal Investigator: Laura Comendador Vázquez, Corporacion Parc Tauli

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laura Comendador-Vazquez, Psychologist, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT05827692
Other Study ID Numbers:
  • 2022/3020
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Laura Comendador-Vazquez, Psychologist, Corporacion Parc Tauli
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2023