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Completed

NCT Number: NCT00893347

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GF Strong Rehab Centre, 4255 Laurel Street

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Treatment as Usual

Behavioral

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

Cognitive-Behavioural Therapy

Behavioral

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

Primary outcomes

  1. PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire)

    Time frame: Pre-intervention and three months later

  2. Functional disability (Mayo-Portland Participation Index)

    Time frame: Pre-intervention and three months later

Secondary outcomes

  1. Illness beliefs (Illness Perceptions Questionnaire-Revised)

    Time frame: Pre-intervention and three months later

  2. Coping style (PCS Coping Inventory)

    Time frame: Pre-intervention and three months later

  3. Psychological distress (Hospital Anxiety and Depression Scale) )

    Time frame: Pre-intervention and three months later

  4. Pain (Brief Pain Scale)

    Time frame: Pre-intervention and three months later

  5. Psychiatric diagnosis (MINI International Neuropsychiatric Interview)

    Time frame: Pre-intervention and three months later

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 6, 2009
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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