Evaluation of Two Treatments for Chronic Post Concussion Syndrome

January 21, 2014 updated by: Kevin Whitfield, Simon Fraser University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5A 1S6
        • Clinical Psychology Centre, Simon Fraser University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post Concussion Symptom Checklist
Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
0 weeks, 2 weeks, 4 weeks, 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Anxiety Sensitivity Index
Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
0 weeks, 2 weeks, 4 weeks, 6 weeks
State Trait Anxiety Inventory
Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
0 weeks, 2 weeks, 4 weeks, 6 weeks
Zung Self Rated Depression Scale
Time Frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
0 weeks, 2 weeks, 4 weeks, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 27, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 21, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234567

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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