Back to resultsEvaluation of Two Treatments for Chronic Post Concussion Syndrome
Primary Purpose
Post Concussion Syndrome, Head Injury
Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Psychoeducation
Relaxation Training
Interoceptive Exposure
Sponsored by
About this trial
This is an interventional treatment trial for Post Concussion Syndrome focused on measuring Post Concussion Syndrome, Cognitive Behavioral Therapy, Anxiety Sensitivity, Mild Head Injury, Psychotherapy, Chronic Post Concussion Symptoms
Eligibility Criteria
Inclusion Criteria:
- Mild Head Injury at least 3 months prior to treatment
- age 19 to 65 years
- grade 12 education
- proficiency with English language
Exclusion Criteria:
- Current Litigation
Sites / Locations
- Clinical Psychology Centre, Simon Fraser University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment As Usual
Experimental
Arm Description
Outcomes
Primary Outcome Measures
Post Concussion Symptom Checklist
Secondary Outcome Measures
Anxiety Sensitivity Index
State Trait Anxiety Inventory
Zung Self Rated Depression Scale
Full Information
NCT ID
NCT00871884
First Posted
March 27, 2009
Last Updated
January 21, 2014
Sponsor
Simon Fraser University
1. Study Identification
Unique Protocol Identification Number
NCT00871884
Brief Title
Evaluation of Two Treatments for Chronic Post Concussion Syndrome
Official Title
The Role of Anxiety Sensitivity in the Maintenance of Chronic Post Concussion Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment, low recruitment.
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Simon Fraser University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to investigate factors that are associated with prolonged recovery from mild head injury. The investigators are particularly interested in defining the impact of anxiety related variables, such as health anxiety and anxiety sensitivity in the maintenance of symptoms.
A further goal of the study is the evaluation of two treatment methods that have been proposed to be effective in reducing the impact of post concussion symptoms. The investigators hypothesize that a treatment which is directly focused on changing these anxiety related variables will be more effective than one that does not.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Concussion Syndrome, Head Injury
Keywords
Post Concussion Syndrome, Cognitive Behavioral Therapy, Anxiety Sensitivity, Mild Head Injury, Psychotherapy, Chronic Post Concussion Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Education about the common prognostic considerations, normal symptoms experienced and etiology of symptoms following mild head injury. Includes some basic suggestions surrounding methods to diminish the impact of symptoms on one's life.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training
Intervention Description
Includes Progressive Muscle Relaxation, Guided Visualization, and various other relaxation techniques to induce deep relaxation.
Intervention Type
Behavioral
Intervention Name(s)
Interoceptive Exposure
Intervention Description
Includes a variety of exercises used to elicit somatic sensations which may be feared by the participant, in an attempt to extinguish or lessen the fear reaction to these sensations.
Primary Outcome Measure Information:
Title
Post Concussion Symptom Checklist
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks
Secondary Outcome Measure Information:
Title
Anxiety Sensitivity Index
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks
Title
State Trait Anxiety Inventory
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks
Title
Zung Self Rated Depression Scale
Time Frame
0 weeks, 2 weeks, 4 weeks, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mild Head Injury at least 3 months prior to treatment
age 19 to 65 years
grade 12 education
proficiency with English language
Exclusion Criteria:
Current Litigation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin C Whitfield, M.A.
Organizational Affiliation
Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allen E Thornton, Ph.D.
Organizational Affiliation
Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alex P Chapman, Ph.D.
Organizational Affiliation
Department of Psychology, Simon fraser University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Cox, Ph.D.
Organizational Affiliation
Department of Psychology, Simon Fraser University
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Psychology Centre, Simon Fraser University
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5A 1S6
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://sfuconcussionstudy.googlepages.com/home
Description
study recruitment homepage
Learn more about this trial
Evaluation of Two Treatments for Chronic Post Concussion Syndrome
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