An Intervention Program to Reduce to the Risk of Persistent Symptoms After Concussion
Primary Purpose
Mild Traumatic Brain Injury
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Treatment as usual
Cognitive-behavioural therapy
Sponsored by
About this trial
This is an interventional prevention trial for Mild Traumatic Brain Injury focused on measuring Mild traumatic brain injury, Concussion, Post-Concussion Syndrome, Cognitive-Behavioural Therapy
Eligibility 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)
Sites / Locations
- GF Strong Rehab Centre, 4255 Laurel Street
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
I
II
Arm Description
Treatment as usual
Treatment as usual + cognitive-behavioural therapy
Outcomes
Primary Outcome Measures
PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire)
Functional disability (Mayo-Portland Participation Index)
Secondary Outcome Measures
Illness beliefs (Illness Perceptions Questionnaire-Revised)
Coping style (PCS Coping Inventory)
Psychological distress (Hospital Anxiety and Depression Scale) )
Pain (Brief Pain Scale)
Psychiatric diagnosis (MINI International Neuropsychiatric Interview)
Full Information
NCT ID
NCT00893347
First Posted
May 4, 2009
Last Updated
November 2, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00893347
Brief Title
An Intervention Program to Reduce to the Risk of Persistent Symptoms After Concussion
Official Title
Prevention of Persistent Post-concussion Syndrome With Cognitive-behavioural Therapy in At-risk Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
Mild traumatic brain injury, Concussion, Post-Concussion Syndrome, Cognitive-Behavioural Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Active Comparator
Arm Description
Treatment as usual
Arm Title
II
Arm Type
Experimental
Arm Description
Treatment as usual + cognitive-behavioural therapy
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioural therapy
Intervention Description
6-session manualized cognitive-behavioural therapy protocol designed to prevent persistent post-concussion syndrome
Primary Outcome Measure Information:
Title
PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire)
Time Frame
Pre-intervention and three months later
Title
Functional disability (Mayo-Portland Participation Index)
Time Frame
Pre-intervention and three months later
Secondary Outcome Measure Information:
Title
Illness beliefs (Illness Perceptions Questionnaire-Revised)
Time Frame
Pre-intervention and three months later
Title
Coping style (PCS Coping Inventory)
Time Frame
Pre-intervention and three months later
Title
Psychological distress (Hospital Anxiety and Depression Scale) )
Time Frame
Pre-intervention and three months later
Title
Pain (Brief Pain Scale)
Time Frame
Pre-intervention and three months later
Title
Psychiatric diagnosis (MINI International Neuropsychiatric Interview)
Time Frame
Pre-intervention and three months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Silverberg, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brad Hallam
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alice Rose
Organizational Affiliation
Vancouver Coastal Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Heather Underwood
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Allen Thornton
Organizational Affiliation
Simon Fraser University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kevin Whitfield
Organizational Affiliation
Simon Fraser University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maureen Whittal
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
GF Strong Rehab Centre, 4255 Laurel Street
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
An Intervention Program to Reduce to the Risk of Persistent Symptoms After Concussion
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