Early Intervention Following Mild TBI

NCT ID: NCT01947504

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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education and support intervention

education and support intervention

Group Type EXPERIMENTAL

education and support intervention

Intervention Type BEHAVIORAL

waiting list

waiting list and regular medical follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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education and support intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Mild TBI

Exclusion Criteria

* Psychiatric diagnosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role collaborator

Elaine De Guise

OTHER

Sponsor Role lead

Responsible Party

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Elaine De Guise

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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McGill University Health Center

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 33656475 (View on PubMed)

Other Identifiers

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MUHC

Identifier Type: OTHER

Identifier Source: secondary_id

3525

Identifier Type: -

Identifier Source: org_study_id

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