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Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03972579
Recruitment Status : Active, not recruiting
First Posted : June 3, 2019
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Noah Silverberg, University of British Columbia

Brief Summary:
At least 1 in 5 people who sustain a concussion will have persistent symptoms and difficulties with daily activities. The researchers have identified two unhelpful coping styles following a concussion - avoidance and endurance. Individuals who engage in avoidance behavior may benefit from a different type of treatment than those who engage in endurance behavior. The researchers will evaluate whether assigning individuals to a specific psychologically-informed treatment tailored to their coping style is practical, acceptable, and beneficial for their recovery.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Behavioral: Graded exposure therapy Behavioral: Pacing + mindfulness Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Graded exposure therapy
Weekly 60-min sessions with an occupational therapist and psychologist over 8 weeks.
Behavioral: Graded exposure therapy
Gradually increased contact with avoided sensory stimuli (e.g., light, noise, movement) and activities (e.g., mental exertion, physical exercise, stressful activities) in order to increase tolerance.

Active Comparator: Pacing + mindfulness
Weekly 60-min sessions with an occupational therapist and psychologist over 8 weeks.
Behavioral: Pacing + mindfulness
Shifting from symptom-contingent to time-contingent activity stopping rules, minimizing activity level peaks (excessive endurance behavior) and valleys (prolonged periods of recuperative rest) to improve overall functioning.




Primary Outcome Measures :
  1. World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item [ Time Frame: Initial assessment, past 30 days. ]

Secondary Outcome Measures :
  1. Rivermead Postconcussion Symptom Questionnaire [ Time Frame: initial assessment, past 24 hours. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Aged 18-70 years old.
  • Sustained a mild traumatic brain injury between 1 and 12 months ago.
  • Fluent in English.
  • Access to a computer, tablet, or smartphone with internet capability.
  • 3+ persistent moderate-severe symptoms on the Rivermead Postconcussion Symptom Questionnaire.
  • High avoidance (Fear Avoidance Behavior after Traumatic Brain Injury; FAB-TBI) and/or endurance behavior (Behavioral Response to Illness Questionnaire - All-Nothing subscale).

Exclusion criteria:

  • Patients with a cardiac contraindication to aerobic exercise will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972579


Locations
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Canada, British Columbia
GF Strong Rehab Centre
Vancouver, British Columbia, Canada, V5Z 2G9
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Noah Silverberg, PhD University of British Columbia
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Responsible Party: Noah Silverberg, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03972579    
Other Study ID Numbers: H18-02344
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating