Evaluation of Two Treatments for Chronic Post Concussion Syndrome

Head Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00871884
• Other study ID #: 1234567
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: March 27, 2009
• Last updated: January 21, 2014
• Start date: April 2008
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Simon Fraser University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injury
• Post Concussion Syndrome
• Post-Concussion Syndrome

Intervention

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

Locations

Country	Name	City	State
Canada	Clinical Psychology Centre, Simon Fraser University	Burnaby	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Simon Fraser University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Concussion Symptom Checklist		0 weeks, 2 weeks, 4 weeks, 6 weeks	No
Secondary	Anxiety Sensitivity Index		0 weeks, 2 weeks, 4 weeks, 6 weeks	No
Secondary	State Trait Anxiety Inventory		0 weeks, 2 weeks, 4 weeks, 6 weeks	No
Secondary	Zung Self Rated Depression Scale		0 weeks, 2 weeks, 4 weeks, 6 weeks	No

External Links

•   study recruitment homepage