Evaluation of Two Treatments for Chronic Post Concussion Syndrome

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00871884

Enrollment

Registered

2009-03-30

Start date

2008-04-30

Completion date

2014-01-31

Last updated

2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Injury, Post Concussion Syndrome

Keywords

Post Concussion Syndrome, Cognitive Behavioral Therapy, Anxiety Sensitivity, Mild Head Injury, Psychotherapy, Chronic Post Concussion Symptoms

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.

Interventions

BEHAVIORALPsychoeducation

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.

BEHAVIORALRelaxation Training

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

BEHAVIORALInteroceptive 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Post Concussion Symptom Checklist	0 weeks, 2 weeks, 4 weeks, 6 weeks

Secondary

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026