Back to resultsEarly Intervention Following Mild TBI
Primary Purpose
Mild Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
education and support intervention
Sponsored by
About this trial
This is an interventional treatment trial for Mild Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Mild TBI
Exclusion Criteria:
- Psychiatric diagnosis
Sites / Locations
- McGill University Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
education and support intervention
waiting list
Arm Description
education and support intervention
waiting list and regular medical follow-up
Outcomes
Primary Outcome Measures
Recurrence of post-concussive symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT01947504
First Posted
September 17, 2013
Last Updated
February 18, 2020
Sponsor
Elaine De Guise
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT01947504
Brief Title
Early Intervention Following Mild TBI
Official Title
Acute and Brief Intervention Following Mild Traumatic Brain Injury: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elaine De Guise
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to implement and measure the efficiency of a standardized acute and brief non-pharmacological intervention (Cognitive interventions on Sleep - Anxiety - Attention - Memory) following mild TBI and observe their impact pre- and post-treatments. The ultimate goal is to have patients be re-integrated to their activities faster with lesser symptoms and have patients present lesser post-concussive symptoms. Specific objectives: 1) Measure the effect of an acute and brief non-pharmacological intervention on PCS symptoms, sleep, headaches, affect, cognition and functional outcome following mild TBI; 2)To redefine a model of outcome prediction following mild TBI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
education and support intervention
Arm Type
Experimental
Arm Description
education and support intervention
Arm Title
waiting list
Arm Type
No Intervention
Arm Description
waiting list and regular medical follow-up
Intervention Type
Behavioral
Intervention Name(s)
education and support intervention
Primary Outcome Measure Information:
Title
Recurrence of post-concussive symptoms
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Mild TBI
Exclusion Criteria:
Psychiatric diagnosis
Facility Information:
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
33656475
Citation
Audrit H, Beauchamp MH, Tinawi S, Lague-Beauvais M, Saluja R, de Guise E. Multidimensional Psychoeducative and Counseling Intervention (SAAM) for Symptomatic Patients With Mild Traumatic Brain Injury: A Pilot Randomized Controlled Trial. J Head Trauma Rehabil. 2021 Jul-Aug 01;36(4):E249-E261. doi: 10.1097/HTR.0000000000000653.
Results Reference
derived
Learn more about this trial
Early Intervention Following Mild TBI
We'll reach out to this number within 24 hrs