Clinical Trials Directory

Trials / Completed

CompletedNCT07368231

Forest Therapy and Mindfulness for Highly Sensitive Persons

Forest Therapy and Mindfulness in Highly Sensitive Persons (HSP): A Multicenter Randomized Interventional Study Over Approximately 22 Weeks

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
310 (actual)
Sponsor
IFM International Forest Medicine · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Detailed description

This is a multicenter, randomized, parallel-group interventional study in adults with high sensory-processing sensitivity confirmed using a validated instrument. Participants are randomized 1:1 to one of two study arms at study entry and remain in their assigned group for the duration of the study. Intervention delivery is standardized across participating sites through facilitator training and a predefined session manual. The experimental arm consists of structured sessions conducted in forest environments and includes guided walking, mindfulness-based practices, and structured sensory awareness activities, with facilitated group reflection. The active comparator arm consists of structured indoor group activities designed to match the experimental arm in duration, group interaction, and facilitator contact, without exposure to forest or outdoor natural environments. Study procedures and assessment schedules are predefined in the protocol and implemented in accordance with applicable ethical requirements and Good Clinical Practice guidelines.

Conditions

Interventions

TypeNameDescription
BEHAVIORALForest Therapy + Mindfulness + PsychotherapyParticipants 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).
BEHAVIORALBehavioral: Indoor Sensory Control (Art and Aromatherapy)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.

Timeline

Start date
2025-05-01
Primary completion
2025-10-03
Completion
2025-10-03
First posted
2026-01-26
Last updated
2026-01-26

Locations

2 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT07368231. Inclusion in this directory is not an endorsement.