Evaluation of Two Treatments for Chronic Post Concussion Syndrome

This study has been terminated.
(Poor enrollment, low recruitment.)
Sponsor:
Information provided by (Responsible Party):
Kevin Whitfield, Simon Fraser University
ClinicalTrials.gov Identifier:
NCT00871884
First received: March 27, 2009
Last updated: January 21, 2014
Last verified: January 2014

March 27, 2009
January 21, 2014
April 2008
January 2014   (final data collection date for primary outcome measure)
Post Concussion Symptom Checklist [ Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00871884 on ClinicalTrials.gov Archive Site
  • Anxiety Sensitivity Index [ Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks ] [ Designated as safety issue: No ]
  • State Trait Anxiety Inventory [ Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks ] [ Designated as safety issue: No ]
  • Zung Self Rated Depression Scale [ Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Two Treatments for Chronic Post Concussion Syndrome
The Role of Anxiety Sensitivity in the Maintenance of Chronic Post Concussion Symptoms

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Post Concussion Syndrome
  • Head Injury
  • Behavioral: Psychoeducation
    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.
  • Behavioral: Relaxation Training
    Includes Progressive Muscle Relaxation, Guided Visualization, and various other relaxation techniques to induce deep relaxation.
  • Behavioral: Interoceptive Exposure
    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.
  • Active Comparator: Treatment As Usual
    Interventions:
    • Behavioral: Psychoeducation
    • Behavioral: Relaxation Training
  • Experimental: Experimental
    Interventions:
    • Behavioral: Psychoeducation
    • Behavioral: Relaxation Training
    • Behavioral: Interoceptive Exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00871884
1234567
Yes
Kevin Whitfield, Simon Fraser University
Simon Fraser University
Not Provided
Principal Investigator: Kevin C Whitfield, M.A. Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University
Study Director: Allen E Thornton, Ph.D. Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University
Study Director: Alex P Chapman, Ph.D. Department of Psychology, Simon fraser University
Study Director: David Cox, Ph.D. Department of Psychology, Simon Fraser University
Simon Fraser University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP