Mild Traumatic Brain InjuryPhase 2NCT00893347
An Intervention Program to Reduce to the Risk of Persistent Symptoms After Concussion
A Phase 2 study testing Treatment as usual and Cognitive-behavioural therapy in people with Mild Traumatic Brain Injury, run by University of British Columbia at 1 site in Canada.
Trial summary
This study investigates how well a new therapy program prevents persistent symptoms (e.g., headaches, fatigue, irritability, etc.) after concussion. The program involves examining beliefs about concussion and learning healthy coping strategies, and is completed with the first three months post-injury. 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?
- Treatment as usual and Cognitive-behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Oct 2012
- Phase
- Phase 2
- 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
- Incurred head trauma within six weeks of study entry
- Meet American Congress of Rehabilitation criteria for MTBI, documented by the referring/treating physician
- Subjective report at least one symptom attributable to head trauma
- English as preferred language for communication
- Considered at-risk for persistent PCS based on prognostic model from Whittaker et al. (2007)
Who cannot join
- Medical documentation of skull fracture or acute intracranial abnormality on neuroimaging, consistent with "mild-complicated" TBI
- Self-reported history of a neurological disorder (including prior MTBI within the past six months)
Trial locations and contacts
1 site in 1 country.
Canada1 site
GF Strong Rehab Centre, 4255 Laurel Street
Vancouver, British Columbia
About this study
Official title: Prevention of Persistent Post-concussion Syndrome With Cognitive-behavioural Therapy in At-risk Patients
This study investigates how well a new therapy program prevents persistent symptoms (e.g., headaches, fatigue, irritability, etc.) after concussion. The program involves examining beliefs about concussion and learning healthy coping strategies, and is completed with the first three months post-injury.
Read the detailed description
Although the majority of patients with mild traumatic brain injury (MTBI) experience complete recovery within three months, a sizeable group continues to report frequent and severe symptoms such as headaches, fatigue, difficulty concentrating, forgetfulness, and irritability, in what is labeled persistent post-concussion syndrome (PCS). Persistent PCS is associated with vocational, recreational, and social disability. Early education and reassurance (treatment as usual) is effective in general, but appears insufficient for this subgroup.
Recent research has identified risk factors for persistent PCS, including inaccurate illness beliefs, maladaptive coping behaviour, and emotional distress. The present study will evaluate the additive efficacy of a cognitive-behavioural therapy protocol designed to modify these risk factors, over and above treatment as usual.
Participants with MTBI will be recruited within six weeks of injury. Those identified as being at-risk for persistent PCS based on evidence-based criteria will receive treatment as usual and then be randomly assigned to receive either no further intervention or cognitive-behavioural therapy. We hypothesize that the group receiving cognitive-behavioural therapy will have fewer PCS symptoms and be less disabled at follow-up. We also hypothesize that compensation-seeking status will mitigate this improvement and that illness beliefs, coping behaviour, and emotional distress will mediate this improvement. A blinded rater will conduct the baseline and outcome assessments.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Treatment as usual, Cognitive-behavioural therapy
- Keywords
- Mild traumatic brain injury, Concussion, Post-Concussion Syndrome, Cognitive-Behavioural Therapy
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualBehavioural
Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management.
Cognitive-behavioural therapyBehavioural
6-session manualized cognitive-behavioural therapy protocol designed to prevent persistent post-concussion syndrome
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Treatment as usual Receives: Behavioral: Treatment as usual |
| II | Experimental | Treatment as usual + cognitive-behavioural therapy Receives: Behavioral: Treatment as usual; Behavioral: Cognitive-behavioural therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire)
Measured: Pre-intervention and three months later
Functional disability (Mayo-Portland Participation Index)
Measured: Pre-intervention and three months later
Secondary outcomes (5)
Illness beliefs (Illness Perceptions Questionnaire-Revised)
Measured: Pre-intervention and three months later
Coping style (PCS Coping Inventory)
Measured: Pre-intervention and three months later
Psychological distress (Hospital Anxiety and Depression Scale) )
Measured: Pre-intervention and three months later
Pain (Brief Pain Scale)
Measured: Pre-intervention and three months later
Psychiatric diagnosis (MINI International Neuropsychiatric Interview)
Measured: Pre-intervention and three months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noah Silverberg, University of British Columbia
- Investigators
- Noah Silverberg, PhD, Principal investigator, University of British ColumbiaBrad Hallam, Study director, University of British ColumbiaAlice Rose, Study director, Vancouver Coastal HealthHeather Underwood, Study director, University of British ColumbiaAllen Thornton, Study director, Simon Fraser UniversityKevin Whitfield, Study director, Simon Fraser UniversityMaureen Whittal, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893347
- Sponsor's protocol ID
- H08-02595
- Status last verified
- Nov 2012
- First submitted
- 4 May 2009
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Persistent Post-concussion Syndrome With Cognitive-behavioural Therapy in At-risk Patients
- ClinicalTrials.gov ID
- NCT00893347
- Acronym / sponsor ID
- H08-02595
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Mild traumatic brain injury, Concussion, Post-Concussion Syndrome, Cognitive-Behavioural Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 May 2009 (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.
This study investigates how well a new therapy program prevents persistent symptoms (e.g., headaches, fatigue, irritability, etc.) after concussion. The program involves examining beliefs about concussion and learning healthy coping strategies, and is completed with the first three months post-injury.
Detailed description
Although the majority of patients with mild traumatic brain injury (MTBI) experience complete recovery within three months, a sizeable group continues to report frequent and severe symptoms such as headaches, fatigue, difficulty concentrating, forgetfulness, and irritability, in what is labeled persistent post-concussion syndrome (PCS). Persistent PCS is associated with vocational, recreational, and social disability. Early education and reassurance (treatment as usual) is effective in general, but appears insufficient for this subgroup.
Recent research has identified risk factors for persistent PCS, including inaccurate illness beliefs, maladaptive coping behaviour, and emotional distress. The present study will evaluate the additive efficacy of a cognitive-behavioural therapy protocol designed to modify these risk factors, over and above treatment as usual.
Participants with MTBI will be recruited within six weeks of injury. Those identified as being at-risk for persistent PCS based on evidence-based criteria will receive treatment as usual and then be randomly assigned to receive either no further intervention or cognitive-behavioural therapy. We hypothesize that the group receiving cognitive-behavioural therapy will have fewer PCS symptoms and be less disabled at follow-up. We also hypothesize that compensation-seeking status will mitigate this improvement and that illness beliefs, coping behaviour, and emotional distress will mediate this improvement. A blinded rater will conduct the baseline and outcome assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Behavioral: Treatment as usualTreatment as usual |
| II | Experimental | Behavioral: Treatment as usual, Behavioral: Cognitive-behavioural therapyTreatment as usual + cognitive-behavioural therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Incurred head trauma within six weeks of study entry
- Meet American Congress of Rehabilitation criteria for MTBI, documented by the referring/treating physician
- Subjective report at least one symptom attributable to head trauma
- English as preferred language for communication
- Considered at-risk for persistent PCS based on prognostic model from Whittaker et al. (2007)
Key exclusion criteria (2 listed)
- Medical documentation of skull fracture or acute intracranial abnormality on neuroimaging, consistent with "mild-complicated" TBI
- Self-reported history of a neurological disorder (including prior MTBI within the past six months)
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 |
|---|---|---|
| Treatment as usualSingle session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management. | Behavioural | I, II |
| Cognitive-behavioural therapy6-session manualized cognitive-behavioural therapy protocol designed to prevent persistent post-concussion syndrome | Behavioural | II |
Primary outcome
PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire)
Time frame: Pre-intervention and three months later
Functional disability (Mayo-Portland Participation Index)
Time frame: Pre-intervention and three months later
5 secondary outcomes
Illness beliefs (Illness Perceptions Questionnaire-Revised)
Time frame: Pre-intervention and three months later
Coping style (PCS Coping Inventory)
Time frame: Pre-intervention and three months later
Psychological distress (Hospital Anxiety and Depression Scale) )
Time frame: Pre-intervention and three months later
Pain (Brief Pain Scale)
Time frame: Pre-intervention and three months later
Psychiatric diagnosis (MINI International Neuropsychiatric Interview)
Time frame: Pre-intervention and three months later
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 6 Nov 2018.
Related trials for Mild Traumatic Brain Injury
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
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.
Noah Silverberg, PhD principal investigator
University of British Columbia
Brad Hallam study director
University of British Columbia
Alice Rose study director
Vancouver Coastal Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment as usual and Cognitive-behavioural therapy in people with Mild Traumatic Brain Injury, run by University of British Columbia 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 5 inclusion and 2 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 6 Nov 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire) (time frame: Pre-intervention and three months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2018.