Evaluation of Two Treatments for Chronic Post Concussion Syndrome

Sponsor

Simon Fraser University (Other)

Overall Status

Terminated

CT.gov ID

NCT00871884

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Post Concussion Syndrome Head Injury	Behavioral: Psychoeducation Behavioral: Relaxation Training Behavioral: Interoceptive Exposure	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Post Concussion Symptom Checklist [0 weeks, 2 weeks, 4 weeks, 6 weeks]

Secondary Outcome Measures

Anxiety Sensitivity Index [0 weeks, 2 weeks, 4 weeks, 6 weeks]
State Trait Anxiety Inventory [0 weeks, 2 weeks, 4 weeks, 6 weeks]
Zung Self Rated Depression Scale [0 weeks, 2 weeks, 4 weeks, 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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