Clinical trial NCT00893347: An Intervention Program to Reduce to the Risk of Persistent Symptoms After Concussion
Official title: Prevention of Persistent Post-concussion Syndrome With Cognitive-behavioural Therapy in At-risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild Traumatic Brain Injury
Keywords: Mild traumatic brain injury
Concussion
Post-Concussion Syndrome
Cognitive-Behavioural Therapy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire)
timeFrame: Pre-intervention and three months later
measure: Functional disability (Mayo-Portland Participation Index)
timeFrame: Pre-intervention and three months later
Secondary outcomes:
measure: Illness beliefs (Illness Perceptions Questionnaire-Revised)
timeFrame: Pre-intervention and three months later
measure: Coping style (PCS Coping Inventory)
timeFrame: Pre-intervention and three months later
measure: Psychological distress (Hospital Anxiety and Depression Scale) )
timeFrame: Pre-intervention and three months later
measure: Pain (Brief Pain Scale)
timeFrame: Pre-intervention and three months later
measure: Psychiatric diagnosis (MINI International Neuropsychiatric Interview)
timeFrame: Pre-intervention and three months later
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehab Centre, 4255 Laurel Street
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Noah Silverberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Brad Hallam
role: STUDY_DIRECTOR
affiliation: Vancouver Coastal Health
name: Alice Rose
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Heather Underwood
role: STUDY_DIRECTOR
affiliation: Simon Fraser University
name: Allen Thornton
role: STUDY_DIRECTOR
affiliation: Simon Fraser University
name: Kevin Whitfield
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Maureen Whittal
role: STUDY_DIRECTOR
References: