MTBI - Mild Traumatic Brain InjuryNCT04982731
Positive Assurance and mTBI
A study testing Positive Assurance in people with MTBI - Mild Traumatic Brain Injury and Concussion, Mild Traumatic Brain Injury, run by Inova Health Care Services at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- MTBI - Mild Traumatic Brain Injury, Concussion, Mild Traumatic Brain Injury
- What is being tested?
- Positive Assurance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to Oct 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 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Subjects must meet the following criteria in order to be eligible to participate:
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- 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
Who cannot join
- 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)
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- 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:
- 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):
- 1. 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Evaluating a Positive Assurance Intervention on Recovery Outcomes in mTBI Patients
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.
Read the detailed description
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).
- Being tested
- Positive Assurance
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive AssuranceOther
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").
| Study group | Role | What they receive |
|---|---|---|
| Positive Assurance Discharge Video Educational Intervention (EDUC). | Experimental | The video intervention will be administered to participants that are randomly assigned to the EDUC group. In addition, current standard of care discharge instructions will also be provided to the participant. This EDUC intervention will consist of a brief, three to five-minute informative video message from the clinical neuropsychologist at the Inova Sports Medicine Concussion Program. Participants will be instructed to view the video at least once every 24 - 48 hours prior to their visit to the concussion clinic. Receives: Other: Positive Assurance |
| Standard of Care Instructions (Treatment as Usual: TAU ) | No intervention | The Acute Concussion Evaluation (ACE) Care plan in place at the Inova PED/GoHealth Urgent Care sites is the standard-of-care discharge instruction for individuals with mTBI. This care plan provides patient and caregiver education about mTBI and emphasizes the monitoring of symptoms, signs of deterioration that may warrant urgent medical attention, and encourages the patient to follow up with their physician for follow up. Participants who are randomized into the TAU group will receive this standard of care treatment in video format, however these participants will not be given a QR code to watch the intervention video. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Regulation Assessment for Concussion (BRAC)
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.
Measured: Gathered at Baseline Visit
Expectations of Recovery Scale
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.
Measured: Gathered at Baseline Visit
Secondary outcomes (4)
State-Trait Anxiety Inventory (STAI)
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.
Measured: Gathered at Baseline Visit and through study completion, an average of one month
mTBI Symptoms
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).
Measured: Gathered at Baseline Visit and through study completion, an average of one month
Immediate Post-concussion Assessment and Cognitive Test (ImPACT)
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.
Measured: Gathered at Baseline Visit and through study completion, an average of one month
Vestibular/Ocular Motor Screening (VOMS)
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.
Measured: Gathered at Baseline Visit and through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start15 Oct 2021
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MTBI - Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 229 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas, Fayetteville
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982731
- Sponsor's protocol ID
- U20-05-4050
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating a Positive Assurance Intervention on Recovery Outcomes in mTBI Patients
- ClinicalTrials.gov ID
- NCT04982731
- Acronym / sponsor ID
- U20-05-4050
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 229 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- University of Arkansas, Fayetteville
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Jul 2021 (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.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Assurance Discharge Video Educational Intervention (EDUC). | Experimental | Other: Positive AssuranceThe video intervention will be administered to participants that are randomly assigned to the EDUC group. In addition, current standard of care discharge instructions will also be provided to the participant. This EDUC intervention will consist of a brief, three to five-minute informative video message from the clinical neuropsychologist at the Inova Sports Medicine Concussion Program. Participants will be instructed to view the video at least once every 24 - 48 hours prior to their visit to the concussion clinic. |
| Standard of Care Instructions (Treatment as Usual: TAU ) | No intervention | –The Acute Concussion Evaluation (ACE) Care plan in place at the Inova PED/GoHealth Urgent Care sites is the standard-of-care discharge instruction for individuals with mTBI. This care plan provides patient and caregiver education about mTBI and emphasizes the monitoring of symptoms, signs of deterioration that may warrant urgent medical attention, and encourages the patient to follow up with their physician for follow up. Participants who are randomized into the TAU group will receive this standard of care treatment in video format, however these participants will not be given a QR code to watch the intervention video. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
- 13-21 years
Key exclusion criteria (31 listed)
- 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)
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 |
|---|---|---|
| Positive AssurancePositive 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"). | Other | Positive Assurance Discharge Video Educational Intervention (EDUC). |
Primary outcome
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.
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.
4 secondary outcomes
State-Trait Anxiety Inventory (STAI)
Time frame: Gathered at Baseline Visit and through study completion, an average of one month
mTBI Symptoms
Time frame: Gathered at Baseline Visit and through study completion, an average of one month
Immediate Post-concussion Assessment and Cognitive Test (ImPACT)
Time frame: Gathered at Baseline Visit and through study completion, an average of one month
Vestibular/Ocular Motor Screening (VOMS)
Time frame: Gathered at Baseline Visit and through study completion
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Assurance in people with MTBI - Mild Traumatic Brain Injury and Concussion, Mild Traumatic Brain Injury, run by Inova Health Care Services 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 10 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Regulation Assessment for Concussion (BRAC) (time frame: Gathered at Baseline Visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.