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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Simon Fraser University:

Primary Outcome Measures:
  • Post Concussion Symptom Checklist [ Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Kevin Whitfield, Research Coordinator, Simon Fraser University
ClinicalTrials.gov Identifier: NCT00871884     History of Changes
Other Study ID Numbers: 1234567
Study First Received: March 27, 2009
Last Updated: January 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on September 30, 2014