Early Intervention Following Mild TBI
Acute and Brief Intervention Following Mild Traumatic Brain Injury: A Randomized Controlled Clinical Trial
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedFebruary 20, 2020
February 1, 2020
2.6 years
September 17, 2013
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence of post-concussive symptoms
1 year
Study Arms (2)
education and support intervention
EXPERIMENTALeducation and support intervention
waiting list
NO INTERVENTIONwaiting list and regular medical follow-up
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Mild TBI
You may not qualify if:
- Psychiatric diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McGill University Health Center
Montreal, Quebec, H3G1A4, Canada
Related Publications (1)
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.
PMID: 33656475DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
September 17, 2013
First Posted
September 20, 2013
Study Start
January 1, 2016
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
February 20, 2020
Record last verified: 2020-02