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Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury

Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04704037
Acronym
M4
Enrollment
537
Registered
2021-01-11
Start date
2021-02-01
Completion date
2025-10-30
Last updated
2026-03-31

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

Conditions

Mild Traumatic Brain Injury

Keywords

Concussion

Brief summary

Mental health problems frequently complicate recovery from mild traumatic brain injury (mTBI) but are under-recognized and under-treated. Our research program aims to identify evidence-based strategies for closing this knowledge-practice gap. Building on a successful pilot trial, the reseachers will evaluate the effectiveness of a clinical practice guideline implementation tool designed to support proactive management of mental health complications after mTBI in primary care.

Detailed description

Goal: To determine if a clinical practice guideline implementation tool, designed to support proactive management of mental health complications, can improve clinical outcomes from mild traumatic brain injury (mTBI). Background: Up to 1 in 4 people who sustain an mTBI develop depression or an anxiety disorder within the first 3 months. Mental health problems triple the risk of long-term disability after mTBI. However, mental health disorders after mTBI are under-detected and under-treated. Canadian clinical practice guidelines for mTBI developed by the Ontario Neurotrauma Foundation (ONF) recommend that family physicians proactively screen and initiate treatment for mental health disorders. Aims: To evaluate the effectiveness of an implementation intervention designed to facilitate timely detection and treatment of mental health complications in primary care. Approach: Triple-blinded (treatment provider, patient, assessor) cluster randomized controlled trial with two arms. The intervention involves collecting screening test results from patients and a complex intervention with two components: sharing the screening test results in an actionable format with their family physician and activating patients for the clinical encounter with the family physician by sharing education materials about mental health problems and treatment options after mTBI. The comparison group is usual care. Hypotheses: The researchers hypothesize that the guideline implementation tool will be associated with lower rates of mental health complications at 26 weeks post-injury, compared to usual care.

Interventions

OTHERGuideline implementation tool

Family physicians will receive a tailored letter with their patient's mental health screening test results and associated mental health treatment recommendations from the Ontario Neurotrauma Foundation guidelines, as well as a list of mental health treatment resources. In addition, the patient will receive a written information package about mental health problems after mTBI and treatment options to discuss with their family physician.

OTHERGeneric information about concussion management

Family physicians will receive a generic letter drawing their attention to Canadian clinical practice guidelines for mild Traumatic Brain Injury (developed by the Ontario Neurotrauma Foundation). Patients will receive instructions about how to access generic education materials about mTBI (from concussion.vch.ca/), which they should have received anyway as part of usual care.

Sponsors

University of British Columbia
Lead SponsorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-69 years old, * presentation to emergency department within 72 hours of injury, * probable mTBI diagnosis per emergency department chart review and interview based on World Health Organization Neurotrauma Task Force diagnostic criteria, * fluent in English, * primary residence in British Columbia, * designate a specific family physician or walk-in clinic where they plan to seek follow-up care

Exclusion criteria

* Pre-existing unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.) * Pre-existing unstable/severe mental illness (e.g., schizophrenia requiring hospital admission in past year)

Design outcomes

Primary

MeasureTime frameDescription
MINI version 7.0.2 for DSM-526 weeks post injuryStructured diagnostic interview

Secondary

MeasureTime frameDescription
Rivermead Postconcussion Symptom Questionnaire2, 12, 26 weeks post injuryStandardized questionnaire
World Health Organization Disability Assessment Schedule 2.0 12-item version12 and 26 week post injuryStandardized interview

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORNoah Silverberg

University of British Columbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026