Mild Traumatic Brain InjuryM4NCT04704037
Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury
A study testing Guideline implementation tool and Generic information about concussion management in people with Mild Traumatic Brain Injury, run by University of British Columbia at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Guideline implementation tool and Generic information about concussion management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- 9 sitesCanada
- Study dates
- 1 Feb 2021to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Urgent and Primary Care Center: North Vancouver
North Vancouver, British Columbia, V7L 1A5
Lion's Gate Hosital
North Vancouver, British Columbia, V7L 2L7
University Hospital of Northern British Columbia
Prince George, British Columbia, V2M 1S2
Richmond Hospital
Richmond, British Columbia, V6X 1A2
Mount Saint Joseph's Hospital
Vancouver, British Columbia, V5T 3N4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
University of British Columbia Hospital
Vancouver, British Columbia, V6T 2B5
Urgent and Primary Care Center: City Center
Vancouver, British Columbia, V6Z 0A3
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
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.
Read the 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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Guideline implementation tool, Generic information about concussion management
- Keywords
- Concussion
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline implementation toolOther
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.
Generic information about concussion managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Minimally enhanced usual care | Active comparator | See intervention/treatment description Receives: Other: Generic information about concussion management |
| Arm 2: Guideline implementation tool | Experimental | See intervention/treatment description Receives: Other: Guideline implementation tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
MINI version 7.0.2 for DSM-5
Structured diagnostic interview
Measured: 26 weeks post injury
Secondary outcomes (2)
Rivermead Postconcussion Symptom Questionnaire
Standardized questionnaire
Measured: 2, 12, 26 weeks post injury
World Health Organization Disability Assessment Schedule 2.0 12-item version
Standardized interview
Measured: 12 and 26 week post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Feb 2021
- Primary completion30 Apr 2023
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Noah Silverberg, University of British Columbia
- Investigators
- Noah Silverberg, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704037
- Sponsor's protocol ID
- H20-00562
- Acronym
- M4
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2021
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request
Publications
Abstracts of the 6th Annual Meeting of the Canadian Concussion Network-Reseau Canadien des Commotions (CCN-RCC). J Head Trauma Rehabil. 2026 Jul-Aug 01;41(4):E424-E475. doi: 10.1097/HTR.0000000000001190. No abstract available.
PubMed 42389945Mikolic A, Snell DL, Theadom A, Faulkner JW, Zemek R, Silverberg ND. The prognostic value of a screening tool for psychological risk factors after mild traumatic brain injury: prospective studies in Canada and New Zealand. BMJ Open. 2025 Sep 10;15(9):e089471. doi: 10.1136/bmjopen-2024-089471.
PubMed 40935420Kashyap I, Silverberg ND, Mikolic A. Gender Differences in Seeking and Receiving Healthcare After Mild Traumatic Brain Injury. J Head Trauma Rehabil. 2025 Nov-Dec 01;40(6):469-478. doi: 10.1097/HTR.0000000000001085. Epub 2025 Nov 4.
PubMed 40705783Silverberg ND, Rioux M, Mikolic A, Perez DL, Burke MJ, Howard A. Somatic Symptom Disorder After Mild Traumatic Brain Injury. J Head Trauma Rehabil. 2026 Jan-Feb 01;41(1):E18-E26. doi: 10.1097/HTR.0000000000001068. Epub 2025 Dec 29.
PubMed 40384095Silverberg ND, Otamendi T, Brasher PM, Brubacher JR, Li LC, Lizotte PP, Panenka WJ, Scheuermeyer FX, Archambault P; Canadian Traumatic Brain Injury Research Consortium (CTRC). 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. 2022 Jun 21;12(6):e062527. doi: 10.1136/bmjopen-2022-062527.
PubMed 35728892
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04704037
- Acronym / sponsor ID
- M4 / H20-00562
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Minimally enhanced usual care | Active comparator | Other: Generic information about concussion managementSee intervention/treatment description |
| Arm 2: Guideline implementation tool | Experimental | Other: Guideline implementation toolSee intervention/treatment description |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guideline implementation toolFamily 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. | Other | Arm 2: Guideline implementation tool |
| Generic information about concussion managementFamily 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. | Other | Arm 1: Minimally enhanced usual care |
Primary outcome
MINI version 7.0.2 for DSM-5
Time frame: 26 weeks post injury
Structured diagnostic interview
2 secondary outcomes
Rivermead Postconcussion Symptom Questionnaire
Time frame: 2, 12, 26 weeks post injury
World Health Organization Disability Assessment Schedule 2.0 12-item version
Time frame: 12 and 26 week post injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Derived from this study: PubMed 42389945Abstracts of the 6th Annual Meeting of the Canadian Concussion Network-Reseau Canadien des Commotions (CCN-RCC). J Head Trauma Rehabil. 2026 Jul-Aug 01;41(4):E424-E475. doi: 10.1097/HTR.0000000000001190. No abstract available.
- Derived from this study: PubMed 40935420Mikolic A, Snell DL, Theadom A, Faulkner JW, Zemek R, Silverberg ND. The prognostic value of a screening tool for psychological risk factors after mild traumatic brain injury: prospective studies in Canada and New Zealand. BMJ Open. 2025 Sep 10;15(9):e089471. doi: 10.1136/bmjopen-2024-089471.
- Derived from this study: PubMed 40705783Kashyap I, Silverberg ND, Mikolic A. Gender Differences in Seeking and Receiving Healthcare After Mild Traumatic Brain Injury. J Head Trauma Rehabil. 2025 Nov-Dec 01;40(6):469-478. doi: 10.1097/HTR.0000000000001085. Epub 2025 Nov 4.
- Derived from this study: PubMed 40384095Silverberg ND, Rioux M, Mikolic A, Perez DL, Burke MJ, Howard A. Somatic Symptom Disorder After Mild Traumatic Brain Injury. J Head Trauma Rehabil. 2026 Jan-Feb 01;41(1):E18-E26. doi: 10.1097/HTR.0000000000001068. Epub 2025 Dec 29.
- Derived from this study: PubMed 35728892Silverberg ND, Otamendi T, Brasher PM, Brubacher JR, Li LC, Lizotte PP, Panenka WJ, Scheuermeyer FX, Archambault P; Canadian Traumatic Brain Injury Research Consortium (CTRC). 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. 2022 Jun 21;12(6):e062527. doi: 10.1136/bmjopen-2022-062527.
- Individual participant dataSharing planned: Yes. Upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Silverberg principal investigator
University of British Columbia
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guideline implementation tool and Generic information about concussion management in people with Mild Traumatic Brain Injury, run by University of British Columbia at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MINI version 7.0.2 for DSM-5 (time frame: 26 weeks post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704037, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.