- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368231
Forest Therapy and Mindfulness for Highly Sensitive Persons (HSP-FOREST)
Forest Therapy and Mindfulness in Highly Sensitive Persons (HSP): A Multicenter Randomized Interventional Study Over Approximately 22 Weeks
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Andalusia
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Ronda, Andalusia, Spain, 29492
- IFM International Forest Medicine
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Ronda, Andalusia, Spain, 29492
- Sessions conducted in natural forest settings within the Serranía de Ronda, specifically the Valle del Genal area
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Forest Therapy + Mindfulness + Psychotherapy
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.
|
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). |
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Perceived Stress Score (PSS-10) From Baseline to End of Intervention
Time Frame: 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.
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Baseline to end of intervention (approximately 22 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Psychological Well-Being Score (WHO-5) From Baseline to End of Intervention
Time Frame: 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.
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Baseline to end of intervention (approximately 22 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Ana I Sánchez Hdz, IFM International Forest Medicine
Publications and helpful links
General Publications
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavior
- Personal Satisfaction
- Psychological Well-Being
- Investigative Techniques
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Behavior Therapy
- Behavioral Disciplines and Activities
- Cognitive Behavioral Therapy
- Reproductive Techniques
- Sensory Art Therapies
- Phytotherapy
- Relaxation Therapy
- Mindfulness
- Psychotherapy
- Aromatherapy
- Forest Therapy
- Reproductive Techniques, Assisted
Other Study ID Numbers
- HSP-FOREST-2025-RTC-C
- HSP-FOREST-2025-C (Registry Identifier: ClinicalTrials.gov)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Study Data/Documents
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Study Protocol
Information identifier: ZENODO17361382Information comments: Access via the URL provided (Zenodo record)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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