Written Versus Verbal Education for Mild Traumatic Brain Injury

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02252315

Enrollment

Registered

2014-09-30

Start date

2015-01-31

Completion date

2016-04-30

Last updated

2018-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Traumatic Brain Injury

Brief summary

Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or alteration in mental status induced by an external mechanical force to the head. Education about symptoms and reassurance of a prompt recovery usually results in full recovery. However, a subgroup appears to have persistent symptoms and disability. This study will recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable patient characteristics that can delay or prevent full recovery. A secondary aim is to determine if providing education in writing or in-person makes a difference.

Interventions

OTHEREducational Brochure

Participants will receive written education materials about mild traumatic brain injury.

OTHERVerbal education module

A structured in-person education module about mild traumatic brain injury.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Confirmation of a likely concussion without hospital admission * Participants live locally with a fixed address * Participants experience at least one new symptom

Exclusion criteria

* Participants who cannot understand/read English

Design outcomes

Primary

Measure	Time frame	Description
Presence of Postconcussional Syndrome	3 Months	The primary outcome is the presence of Postconcussion Syndrome, defined as 3+ symptoms endorsed as mild or greater on the Rivermead Postconcussion Symptom Questionnaire.

Secondary

Measure	Time frame	Description
Glasgow Outcome Scale-Extended (GOS-E)	3 Months	Structured interview to assess disability level.
Patient Health Questionnaire-9 (PHQ-9)	3 Months	Depressive symptoms questionnaire.
PTSD Checklist-Civilian version (PCL-C)	3 Months	Post-traumatic stress symptoms questionnaire.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026