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Nature as Medicine for the Healing Brain: Utilization of a Nature-based Exposure Intervention for Decreasing Concussion Recovery Timeline and Symptom Load

ConditionConcussion (Diagnosis)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-35
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nature-based Guided Awareness Group

    Behavioral

    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 Group

    Behavioral

    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.

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Nature-based Guided Awareness GroupExperimental treatment 1 intervention
Group B: Standard Guided Awareness GroupExperimental treatment 1 intervention
Group C: No Intervention GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Concussion Symptoms Scales

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

Time frame
Daily, for the duration of the 28 day study

Secondary outcomes

1

Stroop Task

Neuropsychological test of processing speed and inhibition

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

Oral Digit Symbol Modalities Task

Neuropsychological measure of attention and memory

Time frame
On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
3

Beck's Depression Inventory

Depression symptom questionnaire

Time frame
On day 1 (visit 1) and day 28 (visit 2) of the 28 day study.
4

Hamilton Anxiety Scale

Anxiety symptom questionnaire

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Penn State University

Lead sponsor

Social Sciences Research Institute at Penn State University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: