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

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893347
• Other study ID #: H08-02595
• Status: Completed
• Phase: Phase 2
• Start date: June 2009
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Post-Concussion Syndrome

Intervention

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

Locations

Country	Name	City	State
Canada	GF Strong Rehab Centre, 4255 Laurel Street	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire)		Pre-intervention and three months later
Primary	Functional disability (Mayo-Portland Participation Index)		Pre-intervention and three months later
Secondary	Illness beliefs (Illness Perceptions Questionnaire-Revised)		Pre-intervention and three months later
Secondary	Coping style (PCS Coping Inventory)		Pre-intervention and three months later
Secondary	Psychological distress (Hospital Anxiety and Depression Scale) )		Pre-intervention and three months later
Secondary	Pain (Brief Pain Scale)		Pre-intervention and three months later
Secondary	Psychiatric diagnosis (MINI International Neuropsychiatric Interview)		Pre-intervention and three months later