NCT00871884

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

5.8 years

First QC Date

March 27, 2009

Last Update Submit

January 21, 2014

Conditions

Post Concussion SyndromeHead Injury

Keywords

Post Concussion SyndromeCognitive Behavioral TherapyAnxiety SensitivityMild Head InjuryPsychotherapyChronic Post Concussion Symptoms

Outcome Measures

Primary Outcomes (1)

  • Post Concussion Symptom Checklist

    0 weeks, 2 weeks, 4 weeks, 6 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

Treatment As Usual

ACTIVE COMPARATOR
Behavioral: PsychoeducationBehavioral: Relaxation Training

Experimental

EXPERIMENTAL
Behavioral: PsychoeducationBehavioral: Relaxation TrainingBehavioral: Interoceptive Exposure

Interventions

PsychoeducationBEHAVIORAL

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.

ExperimentalTreatment As Usual
Relaxation TrainingBEHAVIORAL

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

ExperimentalTreatment As Usual
Interoceptive ExposureBEHAVIORAL

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.

Experimental

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild Head Injury at least 3 months prior to treatment
  • age 19 to 65 years
  • grade 12 education
  • proficiency with English language

You may not qualify if:

  • Current Litigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Psychology Centre, Simon Fraser University

Burnaby, British Columbia, V5A 1S6, Canada

Location

Related Links

MeSH Terms

Conditions

Post-Concussion SyndromeCraniocerebral Trauma

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Brain ConcussionHead Injuries, ClosedTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kevin C Whitfield, M.A.

    Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University

    PRINCIPAL INVESTIGATOR

  • Allen E Thornton, Ph.D.

    Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University

    STUDY DIRECTOR

  • Alex P Chapman, Ph.D.

    Department of Psychology, Simon fraser University

    STUDY DIRECTOR

  • David Cox, Ph.D.

    Department of Psychology, Simon Fraser University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 30, 2009

Study Start

April 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

CA(1)