Evaluation of Two Treatments for Chronic Post Concussion Syndrome

NCT ID: NCT00871884

Last Updated: 2014-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-01-31

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.

Detailed Description

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Conditions

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Post Concussion Syndrome Head Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment As Usual

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

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.

Relaxation Training

Intervention Type BEHAVIORAL

Includes Progressive Muscle Relaxation, Guided Visualization, and various other relaxation techniques to induce deep relaxation.

Experimental

Group Type EXPERIMENTAL

Psychoeducation

Intervention Type BEHAVIORAL

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.

Relaxation Training

Intervention Type BEHAVIORAL

Includes Progressive Muscle Relaxation, Guided Visualization, and various other relaxation techniques to induce deep relaxation.

Interoceptive Exposure

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Relaxation Training

Includes Progressive Muscle Relaxation, Guided Visualization, and various other relaxation techniques to induce deep relaxation.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Simon Fraser University

OTHER

Sponsor Role lead

Responsible Party

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Kevin Whitfield

Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin C Whitfield, M.A.

Role: PRINCIPAL_INVESTIGATOR

Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University

Allen E Thornton, Ph.D.

Role: STUDY_DIRECTOR

Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University

Alex P Chapman, Ph.D.

Role: STUDY_DIRECTOR

Department of Psychology, Simon fraser University

David Cox, Ph.D.

Role: STUDY_DIRECTOR

Department of Psychology, Simon Fraser University

Locations

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Clinical Psychology Centre, Simon Fraser University

Burnaby, British Columbia, Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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1234567

Identifier Type: -

Identifier Source: org_study_id

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