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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00893347
First received: May 4, 2009
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Mild Traumatic Brain Injury
Behavioral: Treatment as usual
Behavioral: Cognitive-behavioural therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prevention of Persistent Post-concussion Syndrome With Cognitive-behavioural Therapy in At-risk Patients

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire) [ Time Frame: Pre-intervention and three months later ] [ Designated as safety issue: No ]
  • Functional disability (Mayo-Portland Participation Index) [ Time Frame: Pre-intervention and three months later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Illness beliefs (Illness Perceptions Questionnaire-Revised) [ Time Frame: Pre-intervention and three months later ] [ Designated as safety issue: No ]
  • Coping style (PCS Coping Inventory) [ Time Frame: Pre-intervention and three months later ] [ Designated as safety issue: No ]
  • Psychological distress (Hospital Anxiety and Depression Scale) ) [ Time Frame: Pre-intervention and three months later ] [ Designated as safety issue: No ]
  • Pain (Brief Pain Scale) [ Time Frame: Pre-intervention and three months later ] [ Designated as safety issue: No ]
  • Psychiatric diagnosis (MINI International Neuropsychiatric Interview) [ Time Frame: Pre-intervention and three months later ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: June 2009
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893347

Locations
Canada, British Columbia
GF Strong Rehab Centre, 4255 Laurel Street
Vancouver, British Columbia, Canada
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00893347     History of Changes
Other Study ID Numbers: H08-02595
Study First Received: May 4, 2009
Last Updated: November 22, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Mild traumatic brain injury
Concussion
Post-Concussion Syndrome
Cognitive-Behavioural Therapy

Additional relevant MeSH terms:
Brain Injuries
Post-Concussion Syndrome
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on August 18, 2014