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Enrolling by Invitation

NCT Number: NCT04982731

Positive Assurance and mTBI

This study will develop and validate a new educational video that provides positive assurance about mild traumatic brain injury (mTBI) recovery for patients with mTBI.

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Key information

Conditions

MTBI - Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Concussion, Mild Traumatic Brain Injury Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inova Health System

Falls Church, Virginia, 22042, United States

About this study

The research team will investigate the effect of this new Positive Assurance discharge intervention video on state anxiety and clinical recovery outcomes in patients with mTBI. A sample of adolescent and young adult patients (13-21yrs) will be recruited for participation that present with a potential mTBI diagnosis and receive specialty referral to the Inova Sports Medicine Concussion Program for follow-up care. Investigators will employ a randomized controlled trial (RCT) to enroll two groups of mTBI patients: 1) a group that receives the video intervention (EDUC), and 2) a group that receives standard discharge instructions (i.e., treatment as usual: TAU).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

COHORT 1 (no longer being recruited):

Inclusion criteria

Subjects must meet the following criteria in order to be eligible to participate:

  • 13-21 years
  • Has sustained an external force to head or body resulting in neurological symptoms and at least one reported symptom is attributed to the mTBI (e.g., dizziness, confusion, headache, postural instability, light/noise sensitivity, nausea)
  • Has receive a medical diagnosis of mTBI from an emergency physical at the IFH Pediatrics ED or Inova-GoHealth Urgent Care clinic within 72 hours of injury
  • Is able to provide remote informed written consent (parent) and assent

Exclusion criteria

Subjects who meet any of the following criteria will not be eligible to participate:

  • Loss of consciousness > 30 minutes in conjunction with the injury
  • Glasgow Coma Scale (GCS) score < 13
  • Has sustained a previous mTBI within the past 6 months
  • Has a neurological disorder (e.g., epilepsy)
  • Has a positive finding on brain imaging (e.g., CT, MRI) that suggests a severe closed head or open injury involving any structural damage or abnormality (e.g., fracture, subdural hematoma)
  • Has a previous history of neurosurgery
  • Does not speak English as a primary language
  • Requires admission to the hospital
  • Has developmental delays
  • Prisoner
  • Pregnant*
  • Has been previously enrolled in the study
  • Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.

COHORT 2:

Inclusion criteria

Subjects must meet the following criteria in order to be eligible to participate:

  • 13-21 years
  • Has scheduled an appointment to be evaluated at the Inova Sports Medicine Concussion Clinic for a traumatic closed head injury that has occurred within the past 30 days
  • The time between study enrollment and the initial clinical visit is at least two days
  • Is able to provide remote informed written consent (parent) and assent

Exclusion criteria

Subjects who meet any of the following criteria will not be eligible to participate:

  • Loss of consciousness > 30 minutes in conjunction with the injury
  • Glasgow Coma Scale (GCS) score < 13
  • Has sustained a previous mTBI within the past 6 months
  • Has a neurological disorder (e.g., epilepsy)
  • Has a positive finding on brain imaging (e.g., CT, MRI) that suggests a severe closed head or open injury involving any structural damage or abnormality (e.g., fracture, subdural hematoma)
  • Has a previous history of neurosurgery
  • Does not speak English as a primary language
  • Requires admission to the hospital
  • Has developmental delays
  • Prisoner
  • Pregnant*
  • Has been previously enrolled in the study
  • Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.

WITHDRAWAL CRITERIA (BOTH COHORTS):

  • Upon examination, if the clinical team determines that a participant did not sustain/cannot confirm a concussion, the subject will be withdrawn from the study.

Treatment and study plan

Positive Assurance

Other

Positive assurance is a low-cost, non-pharmacological strategy commonly used by specialty clinics to manage anxiety in individuals with mTBI. Positive assurance is comprised of words of affirmation given to individuals with a medical condition by a healthcare provider that are centered on hope and positive recovery expectations (i.e., "You will recover," "This can be treated").

Primary outcomes

  1. Behavioral Regulation Assessment for Concussion (BRAC)

    Time frame: Gathered at Baseline Visit

    The Behavioral Regulation Assessment for Concussion (BRAC) is a five-item, four-point Likert scale (with values ranging from '0-Never' to '5-Most of the Time') assessment for the frequency of self-reported behavioral regulation behaviors that occurred during the past seven days. Scores range from 0 to 20, with higher scores indicating a better outcome. Likert scale scores are reported for each item, with a higher score indicating greater frequency. An average score for the BRAC is the average of all the scores across the items.

  2. Expectations of Recovery Scale

    Time frame: Gathered at Baseline Visit

    The Expectations of Recovery Scale will be used to measure the effect of positive assurance on recovery. This is a seven-item scale that asks individuals to assess whether they think they will get better soon, return to usual activities/work within the next month, return to the pre-injury performance and to consider what they had been told about their injury and what those closest to them advised. Items within this scale are scored independently of each other, therefore neither higher nor lower scores indicate a better or worse outcome.

Secondary outcomes

  1. State-Trait Anxiety Inventory (STAI)

    Time frame: Gathered at Baseline Visit and through study completion, an average of one month

    The State-Trait Anxiety Inventory (STAI) will be used to assess state anxiety in participants ages 15 years and older. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that are rated on a four-point Likert scale (1- not at all; 4 - very much so) that evaluate how respondents feel "right now, at this moment." The T-Anxiety scale (STAI Form Y-2) consists of twenty statements rated on a four-point Likert scale (1- almost never; 4 - almost always) that assess how people generally feel. Scores for both scales are continuous and range from 20-80, and clinical levels of state anxiety are classified with scores >40.

  2. mTBI Symptoms

    Time frame: Gathered at Baseline Visit and through study completion, an average of one month

    The Post-Concussion Symptom Scale (PCSS) will be used to assess mTBI symptoms. This measure includes 22 symptoms (e.g., headache, nausea, dizziness, etc…) that are rated by the patient on a seven-point Likert scale (e.g., 0 = mild, 6 = severe). Outcome scores for the PCSS are total number of reported symptoms (0 - 22) and total symptom severity score (0 - 132).

  3. Immediate Post-concussion Assessment and Cognitive Test (ImPACT)

    Time frame: Gathered at Baseline Visit and through study completion, an average of one month

    Investigators will assess cognitive function using the Immediate Post-concussion Assessment and Cognitive Test (ImPACT) computerized tool. ImPACT assesses attention, visual working memory, verbal recognition memory, reaction time, visual processing speed, numerical sequencing ability, and learning.

  4. Vestibular/Ocular Motor Screening (VOMS)

    Time frame: Gathered at Baseline Visit and through study completion

    Investigators will use the Vestibular/Ocular Motor Screening (VOMS) tool to assess vestibular and ocular motor impairment via patient-reported symptom provocation. The VOMS consists of the following five components: 1) smooth pursuits, 2) horizontal and vertical saccades, 3) convergence, 4) horizontal and vertical vestibular ocular reflex (VOR) and 5) visual motion sensitivity (VMS). Self-reported symptom severities (0-10) are reported with each of the five components, with higher ratings reflecting greater symptom severity.

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Collaborators

  • University of Arkansas, Fayetteville

Registry information

Official study title

Developing and Evaluating a Positive Assurance Intervention on Recovery Outcomes in mTBI Patients

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2021
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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