NCT00893347

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	Treatment as usual	Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management.
BEHAVIORAL	Cognitive-behavioural therapy	6-session manualized cognitive-behavioural therapy protocol designed to prevent persistent post-concussion syndrome

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-07-01
• Completion: 2012-10-01
• First posted: 2009-05-06
• Last updated: 2018-11-06

Locations

1 site across 1 country: Canada