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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

537 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2025-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Intervention Following Mild TBI

NCT01947504

Mild Traumatic Brain Injury

COMPLETED NA

Spotting and Managing Adult Repeated Traumas in the Brain

NCT07025317

Brain Injury Traumatic Mild

RECRUITING NA

An Intervention Program to Reduce to the Risk of Persistent Symptoms After Concussion

NCT00893347

Mild Traumatic Brain Injury

COMPLETED PHASE2

Rehabilitation for Functional Memory Symptoms After Concussion

NCT05581810

Mild Traumatic Brain Injury Functional Neurological Disorder

COMPLETED NA

REhabilitation of MEMory Symptoms After BRain Concussion

NCT06956417

Concussion, Brain Mild Traumatic Brain Injury

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1: Minimally enhanced usual care

See intervention/treatment description

Group Type ACTIVE_COMPARATOR

Generic information about concussion management

Intervention Type OTHER

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.

Arm 2: Guideline implementation tool

See intervention/treatment description

Group Type EXPERIMENTAL

Guideline implementation tool

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Guideline 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.

Intervention Type OTHER

Generic 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Noah Silverberg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Noah Silverberg

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Urgent and Primary Care Center: North Vancouver

North Vancouver, British Columbia, Canada

Site Status

Lion's Gate Hosital

North Vancouver, British Columbia, Canada

Site Status

University Hospital of Northern British Columbia

Prince George, British Columbia, Canada

Site Status