Concussion (Diagnosis)NCT07642739
Nature as Medicine for the Healing Brain: Utilization of a Nature-based Exposure Intervention for Decreasing Concussion Recovery Timeline and Symptom Load
A study testing Nature-based Guided Awareness Group and Standard Guided Awareness Group in people with Concussion (Diagnosis), run by Penn State University at 1 site in United States.
Trial summary
The overall goal of this research is to provide pilot data that informs and drives a larger scale research project, incorporating multiple contemporary measurement modalities, to understand the utility and pathological mechanisms by which exposure to nature-based settings may aid in recovery time and symptom relief of… Read more about this study
- Who is it for?
- Ages 14 to 35 years
- Conditions the study is for
- Concussion (Diagnosis)
- What is being tested?
- Nature-based Guided Awareness Group and Standard Guided Awareness Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Require that any participant is 14-35 years old
- Required that any participant under 18 years old can be accompanied by a parent or legal guardian for the duration of the study
- Required that participants be English speakers
- Required that persons be able to provide consent for themselves
- Required that the participant must have suffered a clinically diagnoses concussion 5 days or less prior to the first study visit
- Concussion must have been diagnosed by a licensed clinical medicine professional.
- No additional professional treatment modalities outside of normal clinical concussion recovery recommendations may have been received prior to study participation. These include participation in a separate concussion rehabilitation study, cognitive behavioral therapies, vestibule-ocular therapies (balance), in-patient physical therapy, consumption of stimulant medication, and chiropractic manipulation.
- Injury must have been diagnosed as a concussion or mild-traumatic brain injury. Participant must not have been diagnosed with of severe traumatic brain injury, hematoma, fractured skull or facial bones, or comatose.
Who cannot join
- Exclude persons under 14 years old or over 35 years old
- Exclude persons taking anti-inflammatory drugs (both prescription and OTC), or those who will have taken them within 24 hours prior to Visit 1
- Exclude smokers and former smokers, as defined by CDC. (Anyone who smokes daily or who has smoked at least 100 cigarettes in their lifetime)
- Those with presence of an active infection (including a dental infection)
- Exclude persons who have migraines
- Exclude persons taking mood stabilizer medications
- Exclude persons who have consumed alcohol within 48 hours prior to study participation, participants will be asked this by one of the study members through the exclusion criteria screening form when they first contact the study
- Exclude persons who are pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Recreation Building
University Park, Pennsylvania, 16802
Owen Griffith, PhD, 5709858794, omg5007@psu.edu
Owen Griffith, PhD
About this study
The overall goal of this research is to provide pilot data that informs and drives a larger scale research project, incorporating multiple contemporary measurement modalities, to understand the utility and pathological mechanisms by which exposure to nature-based settings may aid in recovery time and symptom relief of individuals suffering from concussion, and decrease their risk of developing Persistent Post-Concussion Syndrome (PPCS).
We hypothesize that successful adherence to a nature-based exposure therapy intervention program will decrease recovery time and severity of symptom trajectory of concussion, as measured through multimodal assessments of brain structural and functional integrity.
Read the detailed description
This study will use a resting state combined electrophysiological-imaging measure of brain region activation, a blood-based measure of neuroinflammatory protein circulation, and a brief but comprehensive neuropsychological functional assessment to identify recovery status of the brain pre- and post-intervention. Measures will be taken at two pre-determined time intervals following concussion for each participant (1-3 days, 28-30 days) and frame the start and end point of a 4-week nature-based exposure therapy intervention program. The self-administered nature-based exposure therapy intervention will consist of 4 weeks of 120 minutes per week (spread over 3-7 days) of nature-based exposure coupled with a guided environmental awareness prompt list per week (Harries et al., 2025; Leão et al., 2025; White et al., 2019).
The primary aim of this study will be to assess the utility of a nature-based exposure therapy intervention in decreasing symptom severity and timeline of concussion. The intervention will include a multi-week program during which patients will participate in a specified duration of emersion in "nature-based environments". This intervention will inform a low-risk, holistic method for concussion management and may decrease risk of PPCS onset. A multimodal measurement battery will assess structural, functional, and behavioral concussion recovery factors as they relate to the nature-based intervention. Trends in recovery measures will be recorded at pre- and post-intervention, as well as throughout the intervention time period to assess both the feasibility/adherence and efficacy of nature-based exposure on recovery from concussion.
- Conditions
- Concussion (Diagnosis)
- Being tested
- Nature-based Guided Awareness Group, Standard Guided Awareness Group
- Medical subject headings
- Brain Concussion, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-based Guided Awareness GroupBehavioural
Participants in the nature-based guided awareness group will be instructed to perform their intervention prompt in a one of the safe, accessible natural settings provided on the study's Nature-Based Location Guide, 3-7 times per week, for a total duration of 120 minutes per week.
Standard Guided Awareness GroupBehavioural
Participants in the standard guided awareness group will be instructed to perform the prompt in a quiet, controlled indoor environment, 3-7 times per week, for a total duration of 120 minutes per week.
| Study group | Role | What they receive |
|---|---|---|
| Nature-based Guided Awareness Group | Experimental | Participants in the nature-based guided awareness group will be instructed to perform their intervention prompt in a one of the safe, accessible natural settings provided on the study's Nature-Based Location Guide, 3-7 times per week, for a total duration of 120 minutes per week. Receives: Behavioral: Nature-based Guided Awareness Group |
| Standard Guided Awareness Group | Experimental | Participants in the standard guided awareness group will be instructed to perform the prompt in a quiet, controlled indoor environment, 3-7 times per week, for a total duration of 120 minutes per week. Receives: Behavioral: Standard Guided Awareness Group |
| No Intervention Group | No intervention | The No Intervention Group will proceed with their standard clinical care instructions for concussion recovery as provided by their health care professional. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concussion Symptoms Scales
All participants will complete daily Post-Concussion Symptom Scale surveys, offering self-report quantifiable measures of concussion recovery.
Measured: Daily, for the duration of the 28 day study
Secondary outcomes (6)
Stroop Task
Neuropsychological test of processing speed and inhibition
Measured: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Oral Digit Symbol Modalities Task
Neuropsychological measure of attention and memory
Measured: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Beck's Depression Inventory
Depression symptom questionnaire
Measured: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Hamilton Anxiety Scale
Anxiety symptom questionnaire
Measured: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Neuroinflammatory Biomarker Concentration
Blood analysis for circulating concentration of neuroinflammatory protein, Interluken-6
Measured: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
EEG-fNRIS
Combined EEG-fNIRS brain scan to identify regional brain activation. Specifically a resting state EEG-fNIRS will be utilized to compare the timecourse of frontal theta-, beta-, and alpha-wave peak frequency and absolute power versus BOLD signal (oxygenated hemogloben) in the frontal region. Synchronized EEG and fNIRS scans will aid in confirming type and degree of alterations in subcortical brain activity.
Measured: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Concussion (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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 study will utilize a multi-arm model to evaluate both feasibility and disparity in outcomes between three intervention arms: 1) nature-based guided awareness group, 2) standard (non-nature) guided awareness group, 3) non-intervention group (following standard clinical care instructions).
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Social Sciences Research Institute at Penn State University
- Responsible party
- Principal investigator, Owen Griffith, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642739
- Sponsor's protocol ID
- Nature Intervention Concussion
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leao ER, Savieto RM, Borba GB, da Silva Victor E, Bomfim SB, Hingst-Zaher E, Lima LM, Longo LGR, de Oliveira LB, Noguchi DT, Oliveira LPG, Moredo RF, Santos CO, Menini A, Bass LM, Patricio KP, Catissi G, Rosa JM, Soldado EBR, Bertini F, de Barros CG, Kiriyama EJ. Efficacy of a multicomponent nature-based intervention on well-being and environmental engagement: A randomized clinical trial. Environ Int. 2025 Feb;196:109286. doi: 10.1016/j.envint.2025.109286. Epub 2025 Jan 19.
PubMed 39874898Leao ER, Hingst-Zaher E, Savieto RM, Patricio KP, de Oliveira LB, Catissi G, Lima LM, Borba GB, Bomfim SB, de Abreu FB. A time with e-Natureza (e-Nature): a model of nature-based health interventions as a complex adaptive system. Front Psychol. 2023 Aug 22;14:1226197. doi: 10.3389/fpsyg.2023.1226197. eCollection 2023.
PubMed 37674757Gay M, Ray W, Johnson B, Teel E, Geronimo A, Slobounov S. Feasibility of EEG Measures in Conjunction With Light Exercise for Return-to-Play Evaluation After Sports-Related Concussion. Dev Neuropsychol. 2015;40(4):248-53. doi: 10.1080/87565641.2015.1014486.
PubMed 26179490Corazon SS, Olsen LJ, Kaereby N, Poulsen DV, Sidenius U, Bekke-Hansen S, Marschner L. Nature-Based Therapeutic Intervention for Individuals with Post-Concussion Symptoms. Behav Sci (Basel). 2024 Jul 12;14(7):594. doi: 10.3390/bs14070594.
PubMed 39062417
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nature as Medicine for the Healing Brain: Utilization of a Nature-based Exposure Intervention for Decreasing Concussion Recovery Timeline and Symptom Load
- ClinicalTrials.gov ID
- NCT07642739
- Acronym / sponsor ID
- Nature Intervention Concussion
- Conditions
- Concussion (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Social Sciences Research Institute at Penn State University
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 11 Jun 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.
The overall goal of this research is to provide pilot data that informs and drives a larger scale research project, incorporating multiple contemporary measurement modalities, to understand the utility and pathological mechanisms by which exposure to nature-based settings may aid in recovery time and symptom relief of individuals suffering from concussion, and decrease their risk of developing Persistent Post-Concussion Syndrome (PPCS).
We hypothesize that successful adherence to a nature-based exposure therapy intervention program will decrease recovery time and severity of symptom trajectory of concussion, as measured through multimodal assessments of brain structural and functional integrity.
Detailed description
This study will use a resting state combined electrophysiological-imaging measure of brain region activation, a blood-based measure of neuroinflammatory protein circulation, and a brief but comprehensive neuropsychological functional assessment to identify recovery status of the brain pre- and post-intervention. Measures will be taken at two pre-determined time intervals following concussion for each participant (1-3 days, 28-30 days) and frame the start and end point of a 4-week nature-based exposure therapy intervention program. The self-administered nature-based exposure therapy intervention will consist of 4 weeks of 120 minutes per week (spread over 3-7 days) of nature-based exposure coupled with a guided environmental awareness prompt list per week (Harries et al., 2025; Leão et al., 2025; White et al., 2019).
The primary aim of this study will be to assess the utility of a nature-based exposure therapy intervention in decreasing symptom severity and timeline of concussion. The intervention will include a multi-week program during which patients will participate in a specified duration of emersion in "nature-based environments". This intervention will inform a low-risk, holistic method for concussion management and may decrease risk of PPCS onset. A multimodal measurement battery will assess structural, functional, and behavioral concussion recovery factors as they relate to the nature-based intervention. Trends in recovery measures will be recorded at pre- and post-intervention, as well as throughout the intervention time period to assess both the feasibility/adherence and efficacy of nature-based exposure on recovery from concussion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study will utilize a multi-arm model to evaluate both feasibility and disparity in outcomes between three intervention arms: 1) nature-based guided awareness group, 2) standard (non-nature) guided awareness group, 3) non-intervention group (following standard clinical care instructions).
| Arm | Type | Receives |
|---|---|---|
| Nature-based Guided Awareness Group | Experimental | Behavioral: Nature-based Guided Awareness GroupParticipants in the nature-based guided awareness group will be instructed to perform their intervention prompt in a one of the safe, accessible natural settings provided on the study's Nature-Based Location Guide, 3-7 times per week, for a total duration of 120 minutes per week. |
| Standard Guided Awareness Group | Experimental | Behavioral: Standard Guided Awareness GroupParticipants in the standard guided awareness group will be instructed to perform the prompt in a quiet, controlled indoor environment, 3-7 times per week, for a total duration of 120 minutes per week. |
| No Intervention Group | No intervention | –The No Intervention Group will proceed with their standard clinical care instructions for concussion recovery as provided by their health care professional. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Require that any participant is 14-35 years old
- Required that any participant under 18 years old can be accompanied by a parent or legal guardian for the duration of the study
- Required that participants be English speakers
- Required that persons be able to provide consent for themselves
- Required that the participant must have suffered a clinically diagnoses concussion 5 days or less prior to the first study visit
Key exclusion criteria (8 listed)
- Exclude persons under 14 years old or over 35 years old
- Exclude persons taking anti-inflammatory drugs (both prescription and OTC), or those who will have taken them within 24 hours prior to Visit 1
- Exclude smokers and former smokers, as defined by CDC. (Anyone who smokes daily or who has smoked at least 100 cigarettes in their lifetime)
- Those with presence of an active infection (including a dental infection)
- Exclude persons who have migraines
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 |
|---|---|---|
| Nature-based Guided Awareness GroupParticipants in the nature-based guided awareness group will be instructed to perform their intervention prompt in a one of the safe, accessible natural settings provided on the study's Nature-Based Location Guide, 3-7 times per week, for a total duration of 120 minutes per week. | Behavioural | Nature-based Guided Awareness Group |
| Standard Guided Awareness GroupParticipants in the standard guided awareness group will be instructed to perform the prompt in a quiet, controlled indoor environment, 3-7 times per week, for a total duration of 120 minutes per week. | Behavioural | Standard Guided Awareness Group |
Primary outcome
Concussion Symptoms Scales
Time frame: Daily, for the duration of the 28 day study
All participants will complete daily Post-Concussion Symptom Scale surveys, offering self-report quantifiable measures of concussion recovery.
6 secondary outcomes
Stroop Task
Time frame: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Oral Digit Symbol Modalities Task
Time frame: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Beck's Depression Inventory
Time frame: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Hamilton Anxiety Scale
Time frame: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Neuroinflammatory Biomarker Concentration
Time frame: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
EEG-fNRIS
Time frame: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 39874898Leao ER, Savieto RM, Borba GB, da Silva Victor E, Bomfim SB, Hingst-Zaher E, Lima LM, Longo LGR, de Oliveira LB, Noguchi DT, Oliveira LPG, Moredo RF, Santos CO, Menini A, Bass LM, Patricio KP, Catissi G, Rosa JM, Soldado EBR, Bertini F, de Barros CG, Kiriyama EJ. Efficacy of a multicomponent nature-based intervention on well-being and environmental engagement: A randomized clinical trial. Environ Int. 2025 Feb;196:109286. doi: 10.1016/j.envint.2025.109286. Epub 2025 Jan 19.
- Background: PubMed 37674757Leao ER, Hingst-Zaher E, Savieto RM, Patricio KP, de Oliveira LB, Catissi G, Lima LM, Borba GB, Bomfim SB, de Abreu FB. A time with e-Natureza (e-Nature): a model of nature-based health interventions as a complex adaptive system. Front Psychol. 2023 Aug 22;14:1226197. doi: 10.3389/fpsyg.2023.1226197. eCollection 2023.
- Background: PubMed 26179490Gay M, Ray W, Johnson B, Teel E, Geronimo A, Slobounov S. Feasibility of EEG Measures in Conjunction With Light Exercise for Return-to-Play Evaluation After Sports-Related Concussion. Dev Neuropsychol. 2015;40(4):248-53. doi: 10.1080/87565641.2015.1014486.
- Background: PubMed 39062417Corazon SS, Olsen LJ, Kaereby N, Poulsen DV, Sidenius U, Bekke-Hansen S, Marschner L. Nature-Based Therapeutic Intervention for Individuals with Post-Concussion Symptoms. Behav Sci (Basel). 2024 Jul 12;14(7):594. doi: 10.3390/bs14070594.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature-based Guided Awareness Group and Standard Guided Awareness Group in people with Concussion (Diagnosis), run by Penn State University at 1 site in United States.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 11 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Owen Griffith, PhD (15709858794, omg5007@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concussion Symptoms Scales (time frame: Daily, for the duration of the 28 day study). 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 NCT07642739, which also lists 4 linked publications.
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 11 Jun 2026.