Evaluation of Two Treatments for Chronic Post Concussion Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Anxiety Sensitivity in the Maintenance of Chronic Post Concussion Symptoms

Conditions
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Post Concussion Syndrome, Head Injury

Intervention / Treatment
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* Behavioral: Psychoeducation
* Behavioral: Relaxation Training
* Behavioral: Interoceptive Exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment As Usual<br> | Behavioral: Psychoeducation<br>* 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.<br>Behavioral: Relaxation Training<br>* Includes Progressive Muscle Relaxation, Guided Visualization, and various other relaxation techniques to induce deep relaxation.<br>|
| Experimental: Experimental<br> | Behavioral: Psychoeducation<br>* 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.<br>Behavioral: Relaxation Training<br>* Includes Progressive Muscle Relaxation, Guided Visualization, and various other relaxation techniques to induce deep relaxation.<br>Behavioral: Interoceptive Exposure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Concussion Symptom Checklist |  | 0 weeks, 2 weeks, 4 weeks, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Concussion Syndrome, Cognitive Behavioral Therapy, Anxiety Sensitivity, Mild Head Injury, Psychotherapy, Chronic Post Concussion Symptoms