Stress (Psychology)HSP-FORESTNCT07368231
Forest Therapy and Mindfulness for Highly Sensitive Persons
A study testing Forest Therapy + Mindfulness + Psychotherapy in people with Stress (Psychology) and Well-Being, Psychological, run by IFM International Forest Medicine at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress (Psychology), Well-Being, Psychological, Mind-Body Therapies
- What is being tested?
- Forest Therapy + Mindfulness + Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 2 sitesSpain
- Study dates
- 1 May 2025to 3 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
IFM International Forest Medicine
Ronda, Andalusia, 29492
Sessions conducted in natural forest settings within the Serranía de Ronda, specifically the Valle del Genal area
Ronda, Andalusia, 29492
About this study
Official title: Forest Therapy and Mindfulness in Highly Sensitive Persons (HSP): A Multicenter Randomized Interventional Study Over Approximately 22 Weeks
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.
Read the 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
- Stress (Psychology), Well-Being, Psychological, Mind-Body Therapies, Complementary Therapies, Mindfulness, Preventive Medicine
- Being tested
- Forest Therapy + Mindfulness + Psychotherapy, Behavioral: Indoor Sensory Control (Art and Aromatherapy)
- Keywords
- Forest Bathing, Forest Therapy, Shinrin Yoku, Mindfulness, Forest Medicine, Highly Sensitive Person (HSP), Stress reduction, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forest Therapy + Mindfulness + PsychotherapyBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral: Indoor Sensory Control (Art and Aromatherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline to end of intervention (approximately 22 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 May 2025
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress (Psychology)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- IFM International Forest Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana I Sánchez Hdz, Principal investigator, IFM International Forest Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368231
- Sponsor's protocol ID
- HSP-FOREST-2025-RTC-C
- Other IDs
- HSP-FOREST-2025-C
- Acronym
- HSP-FOREST
- Status last verified
- Jan 2026
- First submitted
- 12 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data supporting publications arising from this study will be shared with qualified researchers beginning 6 to 36 months after publication.
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 at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forest Therapy and Mindfulness in Highly Sensitive Persons (HSP): A Multicenter Randomized Interventional Study Over Approximately 22 Weeks
- ClinicalTrials.gov ID
- NCT07368231
- Acronym / sponsor ID
- HSP-FOREST / HSP-FOREST-2025-RTC-C
- Conditions
- Stress (Psychology), Well-Being, Psychological, Mind-Body Therapies, Complementary Therapies, Mindfulness, Preventive Medicine
- Keywords
- Forest Bathing, Forest Therapy, Shinrin Yoku, Mindfulness, Forest Medicine, Highly Sensitive Person (HSP), Stress reduction, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- IFM International Forest MedicineUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Forest Therapy + Mindfulness + Psychotherapy | Experimental | Behavioral: 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 comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forest 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). | Behavioural | Forest Therapy + Mindfulness + Psychotherapy |
| Behavioral: 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. | Behavioural | Indoor Sensory Control (Art and Aromatherapy) |
Primary outcome
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.
1 secondary outcome
Change in Psychological Well-Being Score (WHO-5) From Baseline to End of Intervention
Time frame: Baseline to end of intervention (approximately 22 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Results publicationSánchez 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
- Forest Therapy and Mindfulness for Stress Reduction and Well-being in Highly Sensitive Persons (Pilot RCT)" (HSP-FOREST)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data supporting publications arising from this study will be shared with qualified researchers beginning 6 to 36 months after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana I Sánchez Hdz principal investigator
IFM International Forest Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forest Therapy + Mindfulness + Psychotherapy in people with Stress (Psychology) and Well-Being, Psychological, run by IFM International Forest Medicine at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Score (PSS-10) From Baseline to End of Intervention (time frame: Baseline to end of intervention (approximately 22 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07368231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.