NCT07642739

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

April 8, 2026

Last Update Submit

June 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Concussion Symptoms Scales

    All participants will complete daily Post-Concussion Symptom Scale surveys, offering self-report quantifiable measures of concussion recovery.

    Daily, for the duration of the 28 day study

Secondary Outcomes (6)

  • Stroop Task

    On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.

  • Oral Digit Symbol Modalities Task

    On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.

  • Beck's Depression Inventory

    On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.

  • Hamilton Anxiety Scale

    On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.

  • Neuroinflammatory Biomarker Concentration

    On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.

  • +1 more secondary outcomes

Study Arms (3)

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.

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.

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.

Interventions

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.

Nature-based Guided Awareness Group

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.

Standard Guided Awareness Group

Eligibility Criteria

Age14 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recreation Building

University Park, Pennsylvania, 16802, United States

Location

Related Publications (4)

  • 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.

    PMID: 39874898BACKGROUND
  • Leao 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.

    PMID: 37674757BACKGROUND
  • Gay 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.

    PMID: 26179490BACKGROUND
  • Corazon 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.

    PMID: 39062417BACKGROUND

MeSH Terms

Conditions

Brain ConcussionDisease

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Owen Griffith, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Teaching Professor

Study Record Dates

First Submitted

April 8, 2026

First Posted

June 11, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations