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

NCT05827692 | Unknown DMC

• 1 other identifier: 2022/3020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Well-being

Keywords

forest bath; outdoor therapy; psychological well-being; RCT

Outcome Measures

Primary Outcomes (9)

• 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.

Study Arms (2)

Forest Bath Intervention group A

EXPERIMENTAL

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

Forest Bath Intervention group B

EXPERIMENTAL

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

Interventions

Intervention group A 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 A; Forest Bath Intervention group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laura Comendador-Vazquez: lead
• Universitat Autonoma de Barcelona: collaborator

Study Sites (1)

Coloma Moreno Quiroga

Sabadell, Barcelona, 08206, Spain

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Laura Comendador Vázquez

  Corporacion Parc Tauli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Comendador Vazquez

CONTACT

622054658; Laura.Comendador@uab.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychologist

Model Details: 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).

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 25, 2023
• Study Start: September 13, 2022
• Primary Completion: June 18, 2023
• Study Completion: December 1, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)