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History of Changes for Study: NCT03972579
Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation
Latest version (submitted November 15, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 31, 2019 None (earliest Version on record)
2 May 4, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Description
3 May 5, 2020 Study Description and Study Status
4 November 15, 2021 Recruitment Status, Study Status and Study Design
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Study NCT03972579
Submitted Date:  May 31, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: H18-02344
Brief Title: Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation
Official Title: Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2019
Overall Status: Recruiting
Study Start: May 15, 2019
Primary Completion: February 15, 2021 [Anticipated]
Study Completion: December 1, 2021 [Anticipated]
First Submitted: May 22, 2019
First Submitted that
Met QC Criteria:
May 31, 2019
First Posted: June 3, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
May 31, 2019
Last Update Posted: June 3, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of British Columbia
Responsible Party: Principal Investigator
Investigator: Noah Silverberg
Official Title: Principal Investigator
Affiliation: University of British Columbia
Collaborators: Canadian Institutes of Health Research (CIHR)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:

Psychosocial factors are known to affect recovery from concussion, but are not sufficiently taken into account by current treatment approaches. Distinct behavioral profiles after concussion have emerged in our research: (1) avoidance, where individuals perceive activity as overly dangerous and take care to avoid overexertion, and (2) endurance, where individuals persist with high levels of activity despite worse symptoms until they "crash," requiring recuperative rest. The researchers hypothesize that patients with these behavioral profiles likely benefit from different treatment approaches. The next step in our research program is to evaluate the feasibility and potential impact of tailoring therapies based on an Avoidance-Endurance Model adapted from the chronic pain literature.

The proposed project aims to evaluate whether matching patients with concussion to tailored therapies based on their behavioral profile (avoidance vs endurance) is feasible. A secondary aim is to test our hypothesis that participants receiving the intervention matched to their behavioral profile will have less post-treatment disability than mismatched participants.

In a pilot double-blind (patient, assessor) RCT with 1:1 allocation stratified by behavioral profile (avoidance vs. endurance), 64 adults with persistent symptoms after concussion will complete an initial evaluation, an activity diary over the following week, and then be randomized to receive an interdisciplinary treatment package tailored to avoidance or endurance profiles.

In brief, the program designed for avoidance will involve graded exposure to cognitively demanding activity (e.g., mental math exercises), physical exertion (e.g., treadmill jogging), and sensory stimulation (e.g., scenes with visual motion). The focus of the endurance program will be pacing, i.e., shifting from symptom-contingent to time-contingent behavior. A blinded assessor will administer outcome measures 12 weeks after enrollment. Feasibility criteria include acceptability of randomization and treatment tolerability, fidelity, and adherence.

Open or close this module Conditions
Conditions: Mild Traumatic Brain Injury
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Outcomes Assessor)
Allocation: Randomized
Enrollment: 64 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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. ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 69 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Noah Silverberg, PhD
Telephone: 6047144108
Email: noah.silverberg@vch.ca
Central Contact Backup: Tasha Klotz, BA
Telephone: 6047144108
Email: tasha.klotz@ubc.ca
Study Officials: Noah Silverberg, PhD
Principal Investigator
University of British Columbia
Locations: Canada, British Columbia
GF Strong Rehab Centre
[Recruiting]
Vancouver, British Columbia, Canada, V5Z 2G9
Contact:Contact: Tasha L Klotz, BA 6077341313 Ext. 2316 tasha.klotz@ubc.ca
Contact:Contact: Noah Silverberg, PhD 6047144108 Ext. Silverberg noah.silverberg@vch.ca
Contact:Principal Investigator: Noah D Silveberg, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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