Clinical trialHSP-FORESTNCT07183917
"Forest Therapy and Mindfulness for Stress Reduction and Well-being in Highly Sensitive Persons (Pilot RCT)"
A study testing Forest Therapy and Mindfulness, run by IFM International Forest Medicine at 1 site in Spain.
Trial summary
This study aims to evaluate the effects of Shinrin-Yoku (Forest Bathing) and Forest Medicine interventions on psychological well-being, stress reduction, and overall health outcomes in adults. Shinrin-Yoku, originated in Japan, is a nature-based practice that involves mindful immersion in forest environments. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Forest Therapy and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2025to 30 Apr 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
- Adults aged 18 to 65 years.
- Self-identified as Highly Sensitive Person (HSP) with a score ≥70 on the Highly Sensitive Person Scale (HSP-SC).
- Able to attend weekly sessions for 8 consecutive weeks.
- Willing to provide written informed consent.
Who cannot join
- Current diagnosis of severe psychiatric disorder (e.g., schizophrenia, bipolar disorder not stabilized).
- Current substance abuse or dependence.
- Severe cardiovascular, respiratory, or mobility limitations preventing safe participation in outdoor walking or relaxation exercises.
- Participation in another clinical intervention study during the same period.
Trial locations and contacts
1 site in 1 country.
Spain1 site
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 for Stress Reduction and Well-being in Highly Sensitive Persons: A Randomized Controlled Pilot Trial
This study aims to evaluate the effects of Shinrin-Yoku (Forest Bathing) and Forest Medicine interventions on psychological well-being, stress reduction, and overall health outcomes in adults. Shinrin-Yoku, originated in Japan, is a nature-based practice that involves mindful immersion in forest environments. The intervention combines exposure to natural ecosystems with evidence-based techniques such as mindfulness and guided relaxation.
Participants will be guided through structured sessions in natural forest settings to assess changes in stress biomarkers, emotional regulation, sleep quality, and quality of life. The study is designed as a non-pharmacological, non-invasive intervention, focusing on promoting mental health and preventive medicine.
The findings are expected to provide evidence on the benefits of Forest Medicine as a complementary health approach and contribute to the development of international standards for nature-based therapies.
Read the detailed description
The present study investigates the therapeutic potential of Shinrin-Yoku (Forest Bathing) and Forest Medicine interventions as structured nature-based health practices. Originating in Japan during the 1980s, Shinrin-Yoku has gained recognition worldwide for its reported psychological and physiological benefits. This research seeks to contribute to the scientific evidence supporting these interventions as complementary approaches in preventive and integrative medicine.
Participants will attend guided sessions in natural forest environments. Each session will include periods of mindful walking, sensory awareness exercises, and guided relaxation. No pharmacological or invasive procedures are involved. Outcome measures include validated psychological scales (e.g., stress, anxiety, depression, quality of life), as well as physiological indicators such as heart rate variability and sleep quality.
The study design follows an interventional model focusing on mental health and wellness promotion. Data collection will be conducted before, during, and after the intervention period to assess both immediate and sustained effects.
This project is intended to support the integration of Forest Medicine into broader health strategies, aligning with international research efforts in preventive care, psychosomatic health, and nature-based therapeutic modalities. The study also aims to establish standards for training and best practices in forest-based health interventions across Europe and beyond.
- Being tested
- Forest Therapy and Mindfulness, Indoor Wellness Control
- Keywords
- Forest Bathing, Shinrin-Yoku, Forest Therapy, Highly Sensitive Person (HSP), Integrative Medicine, Preventive Health, Psychological Well-Being, Nature Therapy, Mindfulness, Stress Reduction, Mental healht, Forest meicine
- 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 and MindfulnessBehavioural
Weekly 2-hour guided sessions for 8 consecutive weeks in natural forest environments. Each session includes mindful walking, multisensory awareness (sight, sound, smell, touch), breathing exercises, and guided relaxation practices. Facilitated by certified Forest Therapy and Mindfulness instructors. The intervention is non-invasive, focused on stress reduction, emotional regulation, and improved subjective well-being through mindful immersion in nature.
Indoor Wellness ControlBehavioural
Weekly 2-hour structured sessions for 8 consecutive weeks conducted indoors (classroom or wellness center). Activities include health education talks on stress and wellness, guided music-based relaxation, and eco-friendly culinary tasting experiences. Designed to provide an active comparator condition controlling for attention, group interaction, and wellness-related content without exposure to forest environments or formal mindfulness practices.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Forest Therapy + Mindfulness | Experimental | Weekly 2-hour guided sessions for 8 weeks in natural forest environments, including mindful walking, sensory awareness, breathing exercises, and guided relaxation. Receives: Behavioral: Forest Therapy and Mindfulness |
| Active Comparator: Indoor Wellness Activities | Active comparator | Weekly 2-hour indoor sessions for 8 weeks in a classroom or community center setting, including health education talks, guided relaxation or music therapy, and eco-culinary tasting. Receives: Behavioral: Indoor Wellness Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress (PSS-10)
Mean change in Perceived Stress Scale (10-item version, validated questionnaire) scores from baseline to 8 weeks.
Measured: Baseline and 8 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start13 Jan 2025
- Primary completion15 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized controlled design with 1:1 allocation. Participants are assigned to (a) Forest Therapy + Mindfulness or (b) Indoor Wellness Activities (active control). No crossover is planned. The intervention spans 8 weeks with weekly 2-hour group sessions. Randomization uses a computer-generated sequence with concealed allocation (sealed, opaque envelopes), block sizes of 4-6, and stratification by sex and baseline PSS-10 (median split). Open-label for participants and providers; outcomes assessors/statisticians remain blinded to group codes during analysis.
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- IFM International Forest Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana I. Sánchez Hdz., IFM International Forest Medicine
- Investigators
- ANA I SÁNCHEZ HDZ, Principal Investigator, Study chair, ASEUSY - European Association Shinrin Yoku and Forest Medicine -Ana I Sánchez Hdz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183917
- Sponsor's protocol ID
- HSP-FOREST-2025-RCT
- Acronym
- HSP-FOREST
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forest Therapy and Mindfulness for Stress Reduction and Well-being in Highly Sensitive Persons: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07183917
- Acronym / sponsor ID
- HSP-FOREST / HSP-FOREST-2025-RCT
- Keywords
- Forest Bathing, Shinrin-Yoku, Forest Therapy, Highly Sensitive Person (HSP), Integrative Medicine, Preventive Health, Psychological Well-Being, Nature Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- IFM International Forest MedicineUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Sep 2025 (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 study aims to evaluate the effects of Shinrin-Yoku (Forest Bathing) and Forest Medicine interventions on psychological well-being, stress reduction, and overall health outcomes in adults. Shinrin-Yoku, originated in Japan, is a nature-based practice that involves mindful immersion in forest environments. The intervention combines exposure to natural ecosystems with evidence-based techniques such as mindfulness and guided relaxation.
Participants will be guided through structured sessions in natural forest settings to assess changes in stress biomarkers, emotional regulation, sleep quality, and quality of life. The study is designed as a non-pharmacological, non-invasive intervention, focusing on promoting mental health and preventive medicine.
The findings are expected to provide evidence on the benefits of Forest Medicine as a complementary health approach and contribute to the development of international standards for nature-based therapies.
Detailed description
The present study investigates the therapeutic potential of Shinrin-Yoku (Forest Bathing) and Forest Medicine interventions as structured nature-based health practices. Originating in Japan during the 1980s, Shinrin-Yoku has gained recognition worldwide for its reported psychological and physiological benefits. This research seeks to contribute to the scientific evidence supporting these interventions as complementary approaches in preventive and integrative medicine.
Participants will attend guided sessions in natural forest environments. Each session will include periods of mindful walking, sensory awareness exercises, and guided relaxation. No pharmacological or invasive procedures are involved. Outcome measures include validated psychological scales (e.g., stress, anxiety, depression, quality of life), as well as physiological indicators such as heart rate variability and sleep quality.
The study design follows an interventional model focusing on mental health and wellness promotion. Data collection will be conducted before, during, and after the intervention period to assess both immediate and sustained effects.
This project is intended to support the integration of Forest Medicine into broader health strategies, aligning with international research efforts in preventive care, psychosomatic health, and nature-based therapeutic modalities. The study also aims to establish standards for training and best practices in forest-based health interventions across Europe and beyond.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled design with 1:1 allocation. Participants are assigned to (a) Forest Therapy + Mindfulness or (b) Indoor Wellness Activities (active control). No crossover is planned. The intervention spans 8 weeks with weekly 2-hour group sessions. Randomization uses a computer-generated sequence with concealed allocation (sealed, opaque envelopes), block sizes of 4-6, and stratification by sex and baseline PSS-10 (median split). Open-label for participants and providers; outcomes assessors/statisticians remain blinded to group codes during analysis.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Forest Therapy + Mindfulness | Experimental | Behavioral: Forest Therapy and MindfulnessWeekly 2-hour guided sessions for 8 weeks in natural forest environments, including mindful walking, sensory awareness, breathing exercises, and guided relaxation. |
| Active Comparator: Indoor Wellness Activities | Active comparator | Behavioral: Indoor Wellness ControlWeekly 2-hour indoor sessions for 8 weeks in a classroom or community center setting, including health education talks, guided relaxation or music therapy, and eco-culinary tasting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 65 years.
- Self-identified as Highly Sensitive Person (HSP) with a score ≥70 on the Highly Sensitive Person Scale (HSP-SC).
- Able to attend weekly sessions for 8 consecutive weeks.
- Willing to provide written informed consent.
Key exclusion criteria (4 listed)
- Current diagnosis of severe psychiatric disorder (e.g., schizophrenia, bipolar disorder not stabilized).
- Current substance abuse or dependence.
- Severe cardiovascular, respiratory, or mobility limitations preventing safe participation in outdoor walking or relaxation exercises.
- Participation in another clinical intervention study during the same period.
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 and MindfulnessWeekly 2-hour guided sessions for 8 consecutive weeks in natural forest environments. Each session includes mindful walking, multisensory awareness (sight, sound, smell, touch), breathing exercises, and guided relaxation practices. Facilitated by certified Forest Therapy and Mindfulness instructors. The intervention is non-invasive, focused on stress reduction, emotional regulation, and improved subjective well-being through mindful immersion in nature. | Behavioural | Experimental: Forest Therapy + Mindfulness |
| Indoor Wellness ControlWeekly 2-hour structured sessions for 8 consecutive weeks conducted indoors (classroom or wellness center). Activities include health education talks on stress and wellness, guided music-based relaxation, and eco-friendly culinary tasting experiences. Designed to provide an active comparator condition controlling for attention, group interaction, and wellness-related content without exposure to forest environments or formal mindfulness practices. | Behavioural | Active Comparator: Indoor Wellness Activities |
Primary outcome
Change in Perceived Stress (PSS-10)
Time frame: Baseline and 8 weeks (end of intervention)
Mean change in Perceived Stress Scale (10-item version, validated questionnaire) scores from baseline to 8 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 19 Sep 2025.
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 study chair
ASEUSY - European Association Shinrin Yoku and Forest Medicine -Ana I Sánchez Hdz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forest Therapy and Mindfulness, run by IFM International Forest Medicine at 1 site 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 4 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (PSS-10) (time frame: Baseline and 8 weeks (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2025.