Evaluation of Two Treatments for Chronic Post Concussion Syndrome

Phase 1

Terminated

• Conditions: Post Concussion Syndrome; Head Injury
• Interventions: Behavioral: Psychoeducation; Behavioral: Relaxation Training; Behavioral: Interoceptive Exposure

• Registration Number: NCT00871884
• Lead Sponsor: Simon Fraser University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-03-27
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment As Usual	Psychoeducation	-
Treatment As Usual	Relaxation Training	-
Experimental	Psychoeducation	-
Experimental	Relaxation Training	-
Experimental	Interoceptive Exposure	-

Primary Outcome Measures

Name	Time	Method
Post Concussion Symptom Checklist	0 weeks, 2 weeks, 4 weeks, 6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Psychology Centre, Simon Fraser University; 🇨🇦 Burnaby, British Columbia, Canada