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Forest Therapy and Mindfulness for Highly Sensitive Persons

NCT07368231 — Not applicable, Completed, 310 participants, IFM International Forest Medicine

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

RegistryNCT07368231, acronym HSP-FOREST
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment310 (Actual)
SponsorIFM International Forest Medicine (Other)
ConditionsStress (Psychology), Well-Being, Psychological, Mind-Body Therapies, Complementary Therapies, Mindfulness, Preventive Medicine
InterventionsForest Therapy + Mindfulness + Psychotherapy, Behavioral: Indoor Sensory Control (Art and Aromatherapy) (Behavioral)
Datesstart 2025-05-01, primary completion 2025-10-03, completion 2025-10-03, first posted 2026-01-26, last updated 2026-01-26
Locations2 sites in Spain

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Forest Therapy + Mindfulness + PsychotherapyExperimentalBehavioral: Forest Therapy + Mindfulness + PsychotherapyParticipants 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.
Indoor Sensory Control (Art and Aromatherapy)Active comparatorBehavioral: Behavioral: Indoor Sensory Control (Art and Aromatherapy)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.
  • Forest Therapy + Mindfulness + Psychotherapy (Behavioral): 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).
  • Behavioral: Indoor Sensory Control (Art and Aromatherapy) (Behavioral): 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.

+Outcome measures

Primary outcomes

  • Change in Perceived Stress Score (PSS-10) From Baseline to End of Intervention [Baseline to end of intervention (approximately 22 weeks)]: 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.

Secondary outcomes

  • Change in Psychological Well-Being Score (WHO-5) From Baseline to End of Intervention [Baseline to end of intervention (approximately 22 weeks)]: Measure the difference in total score on the WHO-5 Well-Being Index between baseline and the end of the intervention. WHO-5 comprises 5 items scored 0-25, with higher scores indicating better well-being.

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (2)

FacilityCityCountryStatus
IFM International Forest MedicineRonda, AndalusiaSpain
Sessions conducted in natural forest settings within the Serranía de Ronda, specifically the Valle del Genal areaRonda, AndalusiaSpain

+Publications

  • Results publication: 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

+Investigators

  • Ana I Sánchez Hdz, Principal investigator, IFM International Forest Medicine

My Notes