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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 12, 26 weeks post injury

Awards & highlights

M4 Trial 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.Check my eligibility

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.See study design

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.

M4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am between 18 and 69 years old.

M4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 12, 26 weeks post injury

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MINI version 7.0.2 for DSM-5

Secondary outcome measures

Rivermead Postconcussion Symptom Questionnaire

World Health Organization Disability Assessment Schedule 2.0 12-item version

M4 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,415 Previous Clinical Trials

2,466,479 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,344 Previous Clinical Trials

26,452,880 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any geriatric patients being invited to participate in the study?

"The upper limit for patient enrolment is set at 69 years of age, with a minimum requirement of 18."

Answered by AI

What credentials must applicants possess to be eligible for participation in this clinical research?

"This concussion-related study is taking 537 patients between the ages of 18 and 69. To be eligible, applicants must meet various criteria such as confirmation of diagnosis by a medical professional in line with World Health Organization Neurotrauma Task Force guidelines, English proficiency, primary residence within British Columbia, and an identified family doctor or walk-in clinic for follow up care after 72 hours post injury."

Answered by AI

How widely is this clinical trial being conducted across the country?

"Currently, there are 9 sites that are accepting enrollees. These locations include Prince George, North Vancouver and Richmond; with 6 additional spots scattered throughout the region. To reduce any travel burdens associated with this trial, it is suggested to select a site closest to one's residence."

Answered by AI

Is this clinical research in search of participants at the present time?

"According to clinicaltrials.gov, this medical trial has ceased recruitment of participants; the initial post was made on February 1st 2021 and the last edit occurred November 22nd 2022. Despite this, there are still 923 studies recruiting new patients for their trials at present."

Answered by AI

Recent research and studies

BMJ OpenJournal

Effectiveness of a Guideline Implementation Tool for Supporting Management of Mental Health Complications After Mild Traumatic Brain Injury in Primary Care: Protocol for a Randomised Controlled Trial

Silverberg, Noah D, Thalia Otamendi, Penelope MA Brasher, Jeffrey R Brubacher, Linda C Li, Pierre-Paul Lizotte, William J Panenka, Frank X Scheuermeyer, and Patrick Archambault. 2022. “Effectiveness of a Guideline Implementation Tool for Supporting Management of Mental Health Complications After Mild Traumatic Brain Injury in Primary Care: Protocol for a Randomised Controlled Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2022-062527.

clinicaltrials.govStudy

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

Noah Silverberg 2021. "Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04704037.

All > Concussion > Traumatic Brain Injury