Nature as Medicine for the Healing Brain: Utilization of a Nature-based Exposure Intervention for Decreasing Concussion Recovery Timeline and Symptom Load
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Owen Griffith, PhD
- Telefonní číslo: 15709858794
- E-mail: omg5007@psu.edu
Studijní místa
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Pennsylvania
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University Park, Pennsylvania, Spojené státy, 16802
- Recreation Building
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Kontakt:
- Owen Griffith, PhD
- Telefonní číslo: 5709858794
- E-mail: omg5007@psu.edu
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Vrchní vyšetřovatel:
- Owen Griffith, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Nature-based Guided Awareness Group
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.
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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.
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Experimentální: Standard 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.
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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.
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Žádný zásah: No Intervention Group
The No Intervention Group will proceed with their standard clinical care instructions for concussion recovery as provided by their health care professional.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Concussion Symptoms Scales
Časové okno: Daily, for the duration of the 28 day study
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All participants will complete daily Post-Concussion Symptom Scale surveys, offering self-report quantifiable measures of concussion recovery.
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Daily, for the duration of the 28 day study
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Stroop Task
Časové okno: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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Neuropsychological test of processing speed and inhibition
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On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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Oral Digit Symbol Modalities Task
Časové okno: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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Neuropsychological measure of attention and memory
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On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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Beck's Depression Inventory
Časové okno: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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Depression symptom questionnaire
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On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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Hamilton Anxiety Scale
Časové okno: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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Anxiety symptom questionnaire
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On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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Neuroinflammatory Biomarker Concentration
Časové okno: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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Blood analysis for circulating concentration of neuroinflammatory protein, Interluken-6
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On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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EEG-fNRIS
Časové okno: On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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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.
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On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Poranění mozku, traumatické
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Rány a zranění
- Patologické procesy
- Kraniocerebrální trauma
- Trauma, nervový systém
- Poranění hlavy, uzavřeno
- Rány, Nepenetrující
- Poranění mozku
- Patologické stavy, příznaky a symptomy
- Choroba
- Otřes mozku
Další identifikační čísla studie
- Nature Intervention Concussion
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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