Mild Traumatic Brain InjuryNCT01947504
Early Intervention Following Mild TBI
A study testing education and support intervention in people with Mild Traumatic Brain Injury, run by Elaine De Guise at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- education and support intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Mild TBI
Who cannot join
- Psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Brief Intervention Following Mild Traumatic Brain Injury: A Randomized Controlled Clinical Trial
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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- education and support intervention
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and support interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| education and support intervention | Experimental | education and support intervention Receives: Behavioral: education and support intervention |
| waiting list | No intervention | waiting list and regular medical follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of post-concussive symptoms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJan 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elaine De Guise
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Sponsor-investigator, Elaine De Guise, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947504
- Sponsor's protocol ID
- 3525
- Other IDs
- MUHC
- Status last verified
- Feb 2020
- First submitted
- 17 Sep 2013
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Brief Intervention Following Mild Traumatic Brain Injury: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01947504
- Acronym / sponsor ID
- 3525
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Elaine De GuiseUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- Jan 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| education and support intervention | Experimental | Behavioral: education and support interventioneducation and support intervention |
| waiting list | No intervention | –waiting list and regular medical follow-up |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Mild TBI
Key exclusion criteria (1 listed)
- Psychiatric diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education and support intervention | Behavioural | education and support intervention |
Primary outcome
Recurrence of post-concussive symptoms
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 33656475Audrit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education and support intervention in people with Mild Traumatic Brain Injury, run by Elaine De Guise at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of post-concussive symptoms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020; AzTrials last refreshed its copy on 30 Oct 2026.