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Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury (M4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04704037
Recruitment Status : Active, not recruiting
First Posted : January 11, 2021
Last Update Posted : November 23, 2022
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Noah Silverberg, University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Other: Guideline implementation tool Other: Generic information about concussion management Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 537 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1: Minimally enhanced usual care
See intervention/treatment description
 Other: Generic information about concussion management
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.
Experimental: Arm 2: Guideline implementation tool
See intervention/treatment description
 Other: Guideline implementation tool
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.


Outcome Measures
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Primary Outcome Measures :
  1. MINI version 7.0.2 for DSM-5 [ Time Frame: 26 weeks post injury ]
    Structured diagnostic interview


Secondary Outcome Measures :
  1. Rivermead Postconcussion Symptom Questionnaire [ Time Frame: 2, 12, 26 weeks post injury ]
    Standardized questionnaire

  2. World Health Organization Disability Assessment Schedule 2.0 12-item version [ Time Frame: 12 and 26 week post injury ]
    Standardized interview


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704037


Locations
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Canada, British Columbia
Urgent and Primary Care Center: North Vancouver
North Vancouver, British Columbia, Canada, V7L 1A5
Lion's Gate Hosital
North Vancouver, British Columbia, Canada, V7L 2L7
University Hospital of Northern British Columbia
Prince George, British Columbia, Canada, V2M 1S2
Richmond Hospital
Richmond, British Columbia, Canada, V6X 1A2
Mount Saint Joseph's Hospital
Vancouver, British Columbia, Canada, V5T 3N4
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
University of British Columbia Hospital
Vancouver, British Columbia, Canada, V6T 2B5
Urgent and Primary Care Center: City Center
Vancouver, British Columbia, Canada, V6Z 0A3
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Noah Silverberg University of British Columbia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Noah Silverberg, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT04704037    
Other Study ID Numbers: H20-00562
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon reasonable request
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: October 2025

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noah Silverberg, University of British Columbia:
Concussion
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating