Evaluation of Two Treatments for Chronic Post Concussion Syndrome - Full Text View

Sponsor:	Simon Fraser University
Information provided by:	Simon Fraser University
ClinicalTrials.gov Identifier:	NCT00871884

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 I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control 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:

MedlinePlus related topics: Anxiety Traumatic Brain Injury

U.S. FDA Resources

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 ]

Estimated Enrollment:	70
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment As Usual: Active Comparator	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.

Arms

Assigned Interventions

Treatment As Usual: Active Comparator

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871884

Contacts

Contact: Kevin C Whitfield, M.A.	604-468-3992	kwhitfie@sfu.ca
Contact: Shiftworker Clinical Psychology Centre	778-782-4720

Locations

Canada, British Columbia
Clinical Psychology Centre, Simon Fraser University	Recruiting
Burnaby, British Columbia, Canada, V5A 1S6
Contact: Shiftworker 778-782-4720
Principal Investigator: Kevin C Whitfield, M.A.

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:

study recruitment homepage This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University ( Kevin Whitfield, M.A. Research Coordinator )
Study ID Numbers:	1234567
Study First Received:	March 27, 2009
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00871884 History of Changes
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:

Craniocerebral Trauma
Brain Concussion
Nervous System Diseases
Wounds and Injuries
Head Injuries, Closed
Central Nervous System Diseases

Disorders of Environmental Origin
Post-Concussion Syndrome
Wounds, Nonpenetrating
Trauma, Nervous System
Brain Diseases
Brain Injuries

ClinicalTrials.gov processed this record on March 18, 2010