An Intervention Program to Reduce to the Risk of Persistent Symptoms After Concussion

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Prevention of Persistent Post-concussion Syndrome With Cognitive-behavioural Therapy in At-risk Patients

Conditions
-----------------
Mild Traumatic Brain Injury

Intervention / Treatment
-----------------
* Behavioral: Treatment as usual
* Behavioral: Cognitive-behavioural therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Treatment as usual | Behavioral: Treatment as usual<br>* Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management.<br>|
| Experimental: II<br>Treatment as usual + cognitive-behavioural therapy | Behavioral: Treatment as usual<br>* Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management.<br>Behavioral: Cognitive-behavioural therapy<br>* 6-session manualized cognitive-behavioural therapy protocol designed to prevent persistent post-concussion syndrome<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild traumatic brain injury, Concussion, Post-Concussion Syndrome, Cognitive-Behavioural Therapy