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Behavioural Intervention

Early Mental Health Management for Concussion (M4 Trial)

N/A
Waitlist Available
Led By Noah Silverberg
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presentation to emergency department within 72 hours of injury
Age 18-69 years old
Must not have
Pre-existing unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 12, 26 weeks post injury
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve mental health care for people with mild traumatic brain injury by implementing a clinical practice guideline in primary care.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves the use of informational tools rather than medications, traditional side effects are not applicable. However, there may be indirect effects related to how participants respond to the guidelines and manage their recovery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I went to the emergency room within 3 days of getting injured.
Select...
I am between 18 and 69 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any serious or unstable health conditions like cancer or MS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 12, 26 weeks post injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 12, 26 weeks post injury for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MINI version 7.0.2 for DSM-5
Secondary study objectives
Rivermead Postconcussion Symptom Questionnaire
World Health Organization Disability Assessment Schedule 2.0 12-item version

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Guideline implementation toolExperimental Treatment1 Intervention
See intervention/treatment description
Group II: Arm 1: Minimally enhanced usual careActive Control1 Intervention
See intervention/treatment description

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,465 Previous Clinical Trials
2,484,960 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,386 Previous Clinical Trials
26,515,438 Total Patients Enrolled
Noah SilverbergPrincipal InvestigatorUniversity of British Columbia

Media Library

Clinical Practice Guideline Implementation Tool (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04704037 — N/A
Concussion Clinical Trial 2023: Clinical Practice Guideline Implementation Tool Highlights & Side Effects. Trial Name: NCT04704037 — N/A
Clinical Practice Guideline Implementation Tool (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04704037 — N/A
~113 spots leftby Nov 2025
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