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Evaluation of Two Treatments for Chronic Post Concussion Syndrome

This study has been terminated.
(Poor enrollment, low recruitment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871884
First Posted: March 30, 2009
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kevin Whitfield, Simon Fraser University
  Purpose

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.


Condition Intervention Phase
Post Concussion Syndrome Head Injury Behavioral: Psychoeducation Behavioral: Relaxation Training Behavioral: Interoceptive Exposure Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Role of Anxiety Sensitivity in the Maintenance of Chronic Post Concussion Symptoms

Resource links provided by NLM:


Further study details as provided by Kevin Whitfield, Simon Fraser University:

Primary Outcome Measures:
  • Post Concussion Symptom Checklist [ Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks ]

Secondary Outcome Measures:
  • Anxiety Sensitivity Index [ Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks ]
  • State Trait Anxiety Inventory [ Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks ]
  • Zung Self Rated Depression Scale [ Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks ]

Enrollment: 10
Study Start Date: April 2008
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment As Usual 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.
Experimental: Experimental 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871884


Locations
Canada, British Columbia
Clinical Psychology Centre, Simon Fraser University
Burnaby, British Columbia, Canada, V5A 1S6
Sponsors and Collaborators
Simon Fraser University
Investigators
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
  More Information

Additional Information:
Responsible Party: Kevin Whitfield, Research Coordinator, Simon Fraser University
ClinicalTrials.gov Identifier: NCT00871884     History of Changes
Other Study ID Numbers: 1234567
First Submitted: March 27, 2009
First Posted: March 30, 2009
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Kevin Whitfield, Simon Fraser University:
Post Concussion Syndrome
Cognitive Behavioral Therapy
Anxiety Sensitivity
Mild Head Injury
Psychotherapy
Chronic Post Concussion Symptoms

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