"Forest Therapy and Mindfulness for Stress Reduction and Well-being in Highly Sensitive Persons (Pilot RCT)"

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-13

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate the effects of Shinrin-Yoku (Forest Bathing) and Forest Medicine interventions on psychological well-being, stress reduction, and overall health outcomes in adults. Shinrin-Yoku, originated in Japan, is a nature-based practice that involves mindful immersion in forest environments. The intervention combines exposure to natural ecosystems with evidence-based techniques such as mindfulness and guided relaxation.

Participants will be guided through structured sessions in natural forest settings to assess changes in stress biomarkers, emotional regulation, sleep quality, and quality of life. The study is designed as a non-pharmacological, non-invasive intervention, focusing on promoting mental health and preventive medicine.

The findings are expected to provide evidence on the benefits of Forest Medicine as a complementary health approach and contribute to the development of international standards for nature-based therapies.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Self-help Forest Bathing (Shinrin-yoku) on Depression, Anxiety, and Stress

NCT05743920

Depression, Anxiety Stress

UNKNOWN NA

Do Terpenes Play a Role in the Stress-reducing Effects of a Forest Bathing Intervention?

NCT05316597

Monoterpene Exposure During a Forest Bathing Intervention

COMPLETED NA

Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging

NCT01693874

Anxiety Disorders Depression

COMPLETED PHASE1/PHASE2

Interoceptive Engagement

NCT03583060

Stress

COMPLETED NA

Effects of Forest Bathing in Vancouver, B.C. Parks

NCT05502588

Nature, Human Mental Health Wellness 1 Stress, Psychological +3 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The present study investigates the therapeutic potential of Shinrin-Yoku (Forest Bathing) and Forest Medicine interventions as structured nature-based health practices. Originating in Japan during the 1980s, Shinrin-Yoku has gained recognition worldwide for its reported psychological and physiological benefits. This research seeks to contribute to the scientific evidence supporting these interventions as complementary approaches in preventive and integrative medicine.

Participants will attend guided sessions in natural forest environments. Each session will include periods of mindful walking, sensory awareness exercises, and guided relaxation. No pharmacological or invasive procedures are involved. Outcome measures include validated psychological scales (e.g., stress, anxiety, depression, quality of life), as well as physiological indicators such as heart rate variability and sleep quality.

The study design follows an interventional model focusing on mental health and wellness promotion. Data collection will be conducted before, during, and after the intervention period to assess both immediate and sustained effects.

This project is intended to support the integration of Forest Medicine into broader health strategies, aligning with international research efforts in preventive care, psychosomatic health, and nature-based therapeutic modalities. The study also aims to establish standards for training and best practices in forest-based health interventions across Europe and beyond.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm, parallel-group randomized controlled design with 1:1 allocation. Participants are assigned to (a) Forest Therapy + Mindfulness or (b) Indoor Wellness Activities (active control). No crossover is planned. The intervention spans 8 weeks with weekly 2-hour group sessions. Randomization uses a computer-generated sequence with concealed allocation (sealed, opaque envelopes), block sizes of 4-6, and stratification by sex and baseline PSS-10 (median split). Open-label for participants and providers; outcomes assessors/statisticians remain blinded to group codes during analysis.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Due to the nature of the intervention (forest therapy and mindfulness), blinding is not feasible. This study uses an open-label design.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: Forest Therapy + Mindfulness

Weekly 2-hour guided sessions for 8 weeks in natural forest environments, including mindful walking, sensory awareness, breathing exercises, and guided relaxation.

Group Type EXPERIMENTAL

Forest Therapy and Mindfulness

Intervention Type BEHAVIORAL

Weekly 2-hour guided sessions for 8 consecutive weeks in natural forest environments. Each session includes mindful walking, multisensory awareness (sight, sound, smell, touch), breathing exercises, and guided relaxation practices. Facilitated by certified Forest Therapy and Mindfulness instructors. The intervention is non-invasive, focused on stress reduction, emotional regulation, and improved subjective well-being through mindful immersion in nature.

Active Comparator: Indoor Wellness Activities

Weekly 2-hour indoor sessions for 8 weeks in a classroom or community center setting, including health education talks, guided relaxation or music therapy, and eco-culinary tasting.

Group Type ACTIVE_COMPARATOR

Indoor Wellness Control

Intervention Type BEHAVIORAL

Weekly 2-hour structured sessions for 8 consecutive weeks conducted indoors (classroom or wellness center). Activities include health education talks on stress and wellness, guided music-based relaxation, and eco-friendly culinary tasting experiences. Designed to provide an active comparator condition controlling for attention, group interaction, and wellness-related content without exposure to forest environments or formal mindfulness practices.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Forest Therapy and Mindfulness

Weekly 2-hour guided sessions for 8 consecutive weeks in natural forest environments. Each session includes mindful walking, multisensory awareness (sight, sound, smell, touch), breathing exercises, and guided relaxation practices. Facilitated by certified Forest Therapy and Mindfulness instructors. The intervention is non-invasive, focused on stress reduction, emotional regulation, and improved subjective well-being through mindful immersion in nature.

Intervention Type BEHAVIORAL

Indoor Wellness Control

Weekly 2-hour structured sessions for 8 consecutive weeks conducted indoors (classroom or wellness center). Activities include health education talks on stress and wellness, guided music-based relaxation, and eco-friendly culinary tasting experiences. Designed to provide an active comparator condition controlling for attention, group interaction, and wellness-related content without exposure to forest environments or formal mindfulness practices.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults aged 18 to 65 years.
* Self-identified as Highly Sensitive Person (HSP) with a score ≥70 on the Highly Sensitive Person Scale (HSP-SC).
* Able to attend weekly sessions for 8 consecutive weeks.
* Willing to provide written informed consent.

Exclusion Criteria

* Current diagnosis of severe psychiatric disorder (e.g., schizophrenia, bipolar disorder not stabilized).
* Current substance abuse or dependence.
* Severe cardiovascular, respiratory, or mobility limitations preventing safe participation in outdoor walking or relaxation exercises.
* Participation in another clinical intervention study during the same period.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ana I. Sánchez Hdz.

"Dr. Ana I. Sánchez Hdz., Sponsor-Investigator, IFM International Forest Medicine, responsible for study design, implementation, and compliance with ethical and clinical research standards."

Responsibility Role PRINCIPAL_INVESTIGATOR