NCT07368231

Brief Summary

This randomized, multicenter interventional study evaluates a combined forest therapy (shinrin-yoku) and mindfulness-based program in adults with high sensory-processing sensitivity confirmed using a validated instrument. Participants are randomized (1:1) to either a forest-based intervention or an active indoor sensory control condition. The intervention is delivered over approximately 22 weeks according to a predefined protocol, with assessments conducted at baseline and at the end of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

December 12, 2025

Last Update Submit

January 18, 2026

Conditions

Keywords

Forest BathingForest TherapyShinrin YokuMindfulnessForest MedicineHighly Sensitive Person (HSP)Stress reductionMental Health

Outcome Measures

Primary Outcomes (1)

  • Change in Perceived Stress Score (PSS-10) From Baseline to End of Intervention

    Measure the difference in total score on the Perceived Stress Scale (PSS-10) between baseline and the end of the intervention. PSS-10 comprises 10 items scored 0-40, with higher scores indicating greater perceived stress.

    Baseline to end of intervention (approximately 22 weeks)

Secondary Outcomes (1)

  • Change in Psychological Well-Being Score (WHO-5) From Baseline to End of Intervention

    Baseline to end of intervention (approximately 22 weeks)

Study Arms (2)

Forest Therapy + Mindfulness + Psychotherapy

EXPERIMENTAL

Participants will undergo an approximately 22-week program with 4.5 hours weekly in forest settings. Sessions include a guided forest walk, mindfulness meditation, structured sensory awareness exercises, facilitated group reflection, and a brief psychotherapeutic component focused on emotional processing and cognitive regulation. Intervention delivery is standardized through facilitator training and a predefined session manual.

Behavioral: Forest Therapy + Mindfulness + Psychotherapy

Indoor Sensory Control (Art and Aromatherapy)

ACTIVE COMPARATOR

Structured indoor sensory-based group sessions delivered weekly over approximately 22 weeks. Sessions are designed to match the experimental intervention in duration, structure, facilitator contact, and social interaction, without exposure to forest or outdoor natural environments. Activities include creative tasks, guided aromatherapy, sensory-focused exercises, and facilitated group discussion according to a predefined protocol.

Behavioral: Behavioral: Indoor Sensory Control (Art and Aromatherapy)

Interventions

Participants will undergo a approximately 22-week program with 4.5 hours weekly in forest settings. Each session includes: A 2-hour guided walk with scheduled rest/hydration breaks Mindfulness meditation (20-30 minutes) Discussion/reflection segment (\~20 minutes) for participants to express sensations, experiences, or doubts A psychotherapeutic component focused on emotional processing and cognitive regulation Sensory observation (5-10 minutes) of forest stimuli (olfactory, auditory, tactile, visual) Post-session journaling capturing emotional and sensory feedback Monitoring of environmental parameters (temperature, humidity, wind, estimated phytoncide levels) Standardized facilitator training and session protocols to ensure consistency across sites This protocol is distinguished by integrating forest immersion, mindfulness, psychotherapy, and sensory training in a unified intervention tailored for Highly Sensitive Persons (HSP).

Forest Therapy + Mindfulness + Psychotherapy

Structured indoor sensory-based group sessions delivered weekly over approximately 22 weeks. Activities include creative tasks, guided aromatherapy, and sensory-focused exercises conducted in indoor, non-forest environments. Sessions are designed to match the experimental intervention in duration, structure, facilitator contact, and social interaction, according to a predefined protocol.

Indoor Sensory Control (Art and Aromatherapy)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65 years
  • High sensory-processing sensitivity confirmed using a validated instrument (e.g., HSPS/Aron scale)
  • Able to perform moderate physical activity (e.g., walking)
  • Able to provide written informed consent

You may not qualify if:

  • Severe psychiatric disorder or acute clinical instability
  • Medical condition contraindicating moderate physical activity
  • Use of medications with strong autonomic or neuroendocrine effects (e.g., high-dose systemic corticosteroids; selected beta-blockers)
  • Recent participation in a structured mindfulness or forest-therapy program
  • Pregnancy or unstable medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IFM International Forest Medicine

Ronda, Andalusia, 29492, Spain

Location

Sessions conducted in natural forest settings within the Serranía de Ronda, specifically the Valle del Genal area

Ronda, Andalusia, 29492, Spain

Location

Related Publications (1)

  • Sánchez Hdz, Ana I. Forest Therapy and Mindfulness in Highly Sensitive Persons (HSP): Confirmatory Evidence from a Multicenter Randomized Controlled Trial with 6-Month Follow-up. Zenodo. DOI: 10.5281/zenodo.17361382. Available at: https://zenodo.org/records/17361382

    RESULT

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Forest TherapyMindfulnessPsychotherapyReproductive Techniques, AssistedAromatherapy

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Relaxation TherapyMind-Body TherapiesComplementary TherapiesTherapeuticsCognitive Behavioral TherapyBehavior TherapyBehavioral Disciplines and ActivitiesReproductive TechniquesInvestigative TechniquesPhytotherapySensory Art Therapies

Study Officials

  • Ana I Sánchez Hdz

    IFM International Forest Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the behavioral nature of the interventions, participants and care providers are not blinded. Outcome assessors are masked to group allocation during data collection and evaluation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized, parallel-group interventional study in which participants are assigned in a 1:1 ratio to one of two arms: a forest therapy plus mindfulness intervention or an active indoor sensory control condition. Participants remain in their assigned arm for the full duration of the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2025

First Posted

January 26, 2026

Study Start

May 1, 2025

Primary Completion

October 3, 2025

Study Completion

October 3, 2025

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data supporting publications arising from this study will be shared with qualified researchers beginning 6 to 36 months after publication.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 6 months after publication and available for up to 36 months.
Access Criteria
Access will be granted to qualified researchers upon reasonable request, subject to approval by the responsible ethics committee and execution of a data use agreement. Requests must include a research proposal and analysis plan.

Available IPD Datasets

Study Protocol (ZENODO17361382)Access

Locations