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

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.

Study Overview

• Status: Completed
• Conditions: Mild Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Treatment as usual; Behavioral: Cognitive-behavioural therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • GF Strong Rehab Centre, 4255 Laurel Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: I; Treatment as usual	Behavioral: Treatment as usual; Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management.
Experimental: II; Treatment as usual + cognitive-behavioural therapy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Noah Silverberg, PhD, University of British Columbia; Study Director: 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 record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: May 4, 2009
• First Submitted That Met QC Criteria: May 5, 2009
• First Posted (Estimate): May 6, 2009

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Concussion; Post-Concussion Syndrome; Mild traumatic brain injury; Cognitive-Behavioural Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion
• Other Study ID Numbers: H08-02595