Early Mental Health Management for Concussion

(M4 Trial)

Recruiting at8 trial locations

Overseen by Noah Silverberg

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of British Columbia

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Noah Silverberg

Principal Investigator

University of British Columbia

Eligibility Criteria

This trial is for English-speaking adults aged 18-69 in British Columbia who've had a mild traumatic brain injury (mTBI) and visited the emergency department within 72 hours of their injury. They must have a family physician or clinic for follow-up care. Those with serious medical conditions like cancer, multiple sclerosis, or severe mental illnesses like recent schizophrenia are excluded.

Inclusion Criteria

You have signs of a probable mild traumatic brain injury based on a review of your emergency room records and an interview using specific guidelines for diagnosing head injuries.

I went to the emergency room within 3 days of getting injured.

Fluent in English

Exclusion Criteria

I do not have any serious or unstable health conditions like cancer or MS.

Pre-existing unstable/severe mental illness (e.g., schizophrenia requiring hospital admission in past year)

Treatment Details

Interventions

• Clinical Practice Guideline Implementation Tool (Behavioural Intervention)

Trial Overview The study tests a guideline implementation tool against generic concussion management information to improve early handling of mental health issues after mTBI. It builds on prior research to support primary care proactive management of these complications.

Participant Groups

Group I: Arm 2: Guideline implementation tool Experimental Treatment 1 Intervention

See intervention/treatment description

Group II: Arm 1: Minimally enhanced usual care Active Control 1 Intervention

See intervention/treatment description

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Dr. Christopher Haqq

University of British Columbia

Chief Medical Officer since 2019

MD, University of British Columbia

Bekki Bracken Brown

University of British Columbia

Chief Executive Officer since 2023

Bachelor's degree from Duke University

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa