REhabilitation of MEMory Symptoms After BRain Concussion (REMEMBR)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Noah D Silverberg, PhD
- Phone Number: 2316 6047341313
- Email: noah.silverberg@ubc.ca
Study Contact Backup
- Name: Tasha L Klotz, BA
- Phone Number: 2316 6047341313
- Email: tasha.klotz@ubc.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 2T9
- Recruiting
- Calgary Brain Injury Program
-
Contact:
- Chantel Debert
- Email: chantel.debert@albertahealthservices.ca
-
Contact:
- Christina Campbell
- Email: christina.campbel1@ucalgary.ca
-
-
British Columbia
-
Langley, British Columbia, Canada, V1M 4A6
- Recruiting
- Fraser Health Acquired Brain Injury and Concussion Services
-
Contact:
- William Panenka
- Email: will.panenka@ubc.ca
-
Vancouver, British Columbia, Canada, V5Z 2G9
- Recruiting
- G.F. Strong Adult Concussion Services
-
Contact:
- Sarah Courtice
- Phone Number: 604-734-4113
- Email: Sarah.Courtice@vch.ca
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3Z5
- Active, not recruiting
- Integrated Adult Concussion Program at Hamilton Health Sciences
-
Ottawa, Ontario, Canada, K1H 7X7
- Recruiting
- 360 Concussion Care Clinic
-
Contact:
- Roger Zemek
- Phone Number: 1-613-668-0360
- Email: roger.zemek@360concussioncare.com
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Traumatic Brain Injury Clinic
-
Contact:
- Matthew Burke
- Email: matthew.burke@sunnybrook.ca
-
Toronto, Ontario, Canada, M5G 2A2
- Recruiting
- Hull-Ellis Concussion and Research Clinic at University Health Network
-
Contact:
- Mark Bayley
- Email: mark.bayley@uhn.ca
-
Contact:
- Tharshini Chandra
- Phone Number: 3645 (416) 597-3422
- Email: tharshini.chandra@uhn.ca
-
Toronto, Ontario, Canada, M5T 2S8
- Recruiting
- Canadian Concussion Centre at Toronto Western Hospital
-
Contact:
- Artee Srivastava
- Email: Artee.Srivastava@uhn.ca
-
Contact:
- Carmela Tartaglia
- Phone Number: 416-603-5483
- Email: carmela.tartaglia@uhn.ca
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-59
- Concussion diagnosis confirmed with structured interview based on American Congress of Rehabilitation Medicine diagnostic criteria
- Concussion occurred between 6 and 36 months before enrollment
- Ongoing memory concerns
- Fluent in English
- Stable access to a computer, tablet, or smartphone with internet capability
Exclusion Criteria:
- Fail performance validity testing
- Comorbid psychiatric or neurological disorder or is taking a medication that could fully account for their memory symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Waitlist - Usual care
|
|
|
Experimental: Cognitive behavioral therapy
|
Cognitive behavioral therapy (CBT) is delivered by a psychologist over 10 individual (1:1) manualized videoconference sessions.
The goal of this therapy is for participants to use their memory more normally (i.e., reduce avoidance and safety behaviors) and view memory lapses as less threatening.
|
|
Active Comparator: Cognitive rehabilitation
|
Cognitive compensatory strategy training (CCST), a traditional cognitive rehabilitation intervention, is delivered by a Occupational Therapist over 10 individual (1:1) manualized videoconference sessions.
Participants optimize their use of current compensatory strategies and/or learn new ones suited to their needs and lifestyle.
The goal is to minimize memory lapses in daily life.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multifactorial Memory Questionnaire-Satisfaction scale
Time Frame: Week 20
|
Measures participants' concern, satisfaction, and overall appraisal of their memory ability.
Participants rate their agreement with 18 statements.
Total scores range from 0 to 72, with lower total scores indicating worse subjective memory functioning.
|
Week 20
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fear-Avoidance of Memory Loss Scale
Time Frame: Week 1 and week 20
|
Assesses fears and avoidance behaviors associated with memory decline.
Participants rate 24 items on a 5-point scale, where the higher scores indicate greater memory concern and maladaptive coping.
|
Week 1 and week 20
|
|
Patient Global Impression of Change scale
Time Frame: Week 20
|
Participants rate how much their memory functioning has improved or declined overall since the beginning of the study, on a single item rated on a 7-point scale where the midpoint is no change.
|
Week 20
|
|
Work and Social Adjustment Scale
Time Frame: Week 1 and week 20
|
Participants rate how much their condition interferes with their ability to carry out occupational and social activities across 5 items, on a scale from 1-7 where higher scores indicate more difficulty.
|
Week 1 and week 20
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Noah D Silverberg, PhD, University of British Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Injuries, Traumatic
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries
- Brain Concussion
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Neurological Rehabilitation
- Cognitive Behavioral Therapy
- Cognitive Training
Other Study ID Numbers
Other Study ID Numbers
- H24-02486
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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