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CompletedNCT01947504Updated Feb 20, 2020

Early Intervention Following Mild TBI

An interventional study of education and support intervention in Mild Traumatic Brain Injury, sponsored by Elaine De Guise. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Elaine De Guise · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 30 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

This is the only study on the registry with Elaine De Guise as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of Mild TBI

Exclusion criteria

Exclusion Criteria:

  • Psychiatric diagnosis
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    education and support intervention

    education and support intervention

    Behavioral: education and support intervention

  • No intervention
    waiting list

    waiting list and regular medical follow-up

Interventions

  • Behavioraleducation and support intervention
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What researchers measure

Primary outcomes

  1. Recurrence of post-concussive symptoms

    Time frame: 1 year

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Study locations

1 site
  • McGill University Health Center
    Montreal, Quebec H3G1A4, Canada
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References and documents

Publications

  • 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. PubMed 33656475 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01947504
Lead sponsor
Elaine De Guise
Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible party
Elaine De Guise (Assistant professor, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Sponsor-investigator
First posted
Sep 20, 2013
Start date
Jan 2016
Primary completion
Aug 2018
Completion
Aug 2018
Last update
Feb 20, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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