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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00893347
Enrollment
28
Registered
2009-05-06
Start date
2009-06-30
Completion date
2012-10-31
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Traumatic Brain Injury

Keywords

Mild traumatic brain injury, Concussion, Post-Concussion Syndrome, Cognitive-Behavioural Therapy

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.

Interventions

BEHAVIORALTreatment as usual

Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management.

6-session manualized cognitive-behavioural therapy protocol designed to prevent persistent post-concussion syndrome

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Psychological distress (Hospital Anxiety and Depression Scale) )Pre-intervention and three months later
Illness beliefs (Illness Perceptions Questionnaire-Revised)Pre-intervention and three months later
Psychiatric diagnosis (MINI International Neuropsychiatric Interview)Pre-intervention and three months later
Pain (Brief Pain Scale)Pre-intervention and three months later
Coping style (PCS Coping Inventory)Pre-intervention and three months later

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026