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

NCT04704037 | Completed

• 1 other identifier: H20-00562
• Study Type: interventional
• Target: 537
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Mild Traumatic Brain Injury

Keywords

Concussion

Outcome Measures

Primary Outcomes (1)

• MINI version 7.0.2 for DSM-5

  Structured diagnostic interview

  26 weeks post injury

Secondary Outcomes (2)

• Rivermead Postconcussion Symptom Questionnaire

  2, 12, 26 weeks post injury

• World Health Organization Disability Assessment Schedule 2.0 12-item version

  12 and 26 week post injury

Study Arms (2)

Arm 1: Minimally enhanced usual care

ACTIVE COMPARATOR

See intervention/treatment description

Other: Generic information about concussion management

Arm 2: Guideline implementation tool

EXPERIMENTAL

See intervention/treatment description

Other: Guideline implementation tool

Interventions

Guideline implementation tool 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.

Arm 2: Guideline implementation tool

Generic information about concussion management 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 1: Minimally enhanced usual care

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (9)

Urgent and Primary Care Center: North Vancouver

North Vancouver, British Columbia, V7L 1A5, Canada

Location

Lion's Gate Hosital

North Vancouver, British Columbia, V7L 2L7, Canada

Location

University Hospital of Northern British Columbia

Prince George, British Columbia, V2M 1S2, Canada

Location

Richmond Hospital

Richmond, British Columbia, V6X 1A2, Canada

Location

Mount Saint Joseph's Hospital

Vancouver, British Columbia, V5T 3N4, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University of British Columbia Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

Urgent and Primary Care Center: City Center

Vancouver, British Columbia, V6Z 0A3, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (4)

• Mikolic 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.

  PMID: 40935420 DERIVED

• Kashyap 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.

  PMID: 40705783 DERIVED

• Silverberg 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.

  PMID: 40384095 DERIVED

• Silverberg 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.

  PMID: 35728892 DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Noah Silverberg

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: February 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: October 30, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: October 2025

Locations

CA (9)