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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Active Comparator | Treatment as usual |
|
| II | Experimental | Treatment as usual + cognitive-behavioural therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment as usual | Behavioral | Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management. |
| Measure | Description | Time Frame |
|---|---|---|
| PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire) | Pre-intervention and three months later | |
| Functional disability (Mayo-Portland Participation Index) | Pre-intervention and three months later |
| Measure | Description | Time Frame |
|---|---|---|
| Illness beliefs (Illness Perceptions Questionnaire-Revised) | Pre-intervention and three months later | |
| Coping style (PCS Coping Inventory) | Pre-intervention and three months later | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noah Silverberg, PhD | University of British Columbia | Principal Investigator |
| Brad Hallam | University of British Columbia | Study Director |
| Alice Rose | Vancouver Coastal Health | Study Director |
| Heather Underwood | University of British Columbia | Study Director |
| Allen Thornton | Simon Fraser University | Study Director |
| Kevin Whitfield | Simon Fraser University | Study Director |
| Maureen Whittal | University of British Columbia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GF Strong Rehab Centre, 4255 Laurel Street | Vancouver | British Columbia | Canada |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive-behavioural therapy | Behavioral | 6-session manualized cognitive-behavioural therapy protocol designed to prevent persistent post-concussion syndrome |
|
| Psychological distress (Hospital Anxiety and Depression Scale) ) |
| Pre-intervention and three months later |
| Pain (Brief Pain Scale) | Pre-intervention and three months later |
| Psychiatric diagnosis (MINI International Neuropsychiatric Interview) | Pre-intervention and three months later |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |