NCT00893347

Brief Summary

This study investigates how well a new therapy program prevents persistent symptoms (e.g., headaches, fatigue, irritability, etc.) after concussion. The program involves examining beliefs about concussion and learning healthy coping strategies, and is completed with the first three months post-injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2012

Enrollment Period

3.1 years

First QC Date

May 4, 2009

Last Update Submit

November 2, 2018

Conditions

Mild Traumatic Brain Injury

Keywords

Mild traumatic brain injuryConcussionPost-Concussion SyndromeCognitive-Behavioural Therapy

Outcome Measures

Primary Outcomes (2)

  • PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire)

    Pre-intervention and three months later

  • Functional disability (Mayo-Portland Participation Index)

    Pre-intervention and three months later

Secondary Outcomes (5)

  • Illness beliefs (Illness Perceptions Questionnaire-Revised)

    Pre-intervention and three months later

  • Coping style (PCS Coping Inventory)

    Pre-intervention and three months later

  • Psychological distress (Hospital Anxiety and Depression Scale) )

    Pre-intervention and three months later

  • Pain (Brief Pain Scale)

    Pre-intervention and three months later

  • Psychiatric diagnosis (MINI International Neuropsychiatric Interview)

    Pre-intervention and three months later

Study Arms (2)

I

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Treatment as usual

II

EXPERIMENTAL

Treatment as usual + cognitive-behavioural therapy

Behavioral: Treatment as usualBehavioral: Cognitive-behavioural therapy

Interventions

Treatment as usualBEHAVIORAL

Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management.

III
Cognitive-behavioural therapyBEHAVIORAL

6-session manualized cognitive-behavioural therapy protocol designed to prevent persistent post-concussion syndrome

II

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Incurred head trauma within six weeks of study entry
  • Meet American Congress of Rehabilitation criteria for MTBI, documented by the referring/treating physician
  • Subjective report at least one symptom attributable to head trauma
  • English as preferred language for communication
  • Considered at-risk for persistent PCS based on prognostic model from Whittaker et al. (2007)

You may not qualify if:

  • Medical documentation of skull fracture or acute intracranial abnormality on neuroimaging, consistent with "mild-complicated" TBI
  • Self-reported history of a neurological disorder (including prior MTBI within the past six months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GF Strong Rehab Centre, 4255 Laurel Street

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Brain ConcussionPost-Concussion Syndrome

Interventions

TherapeuticsCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Noah Silverberg, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Brad Hallam

    University of British Columbia

    STUDY DIRECTOR

  • Alice Rose

    Vancouver Coastal Health

    STUDY DIRECTOR

  • Heather Underwood

    University of British Columbia

    STUDY DIRECTOR

  • Allen Thornton

    Simon Fraser University

    STUDY DIRECTOR

  • Kevin Whitfield

    Simon Fraser University

    STUDY DIRECTOR

  • Maureen Whittal

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 6, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

November 6, 2018

Record last verified: 2012-11

Locations

CA(1)