NCT04982731

Positive Assurance and mTBI

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 229 (estimated)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 13 Years – 21 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• MTBI - Mild Traumatic Brain Injury
• Concussion, Mild Traumatic Brain Injury

Interventions

Type	Name	Description
OTHER	Positive Assurance	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").

Timeline

• Start date: 2021-10-15
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2021-07-29
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States