REhabilitation of MEMory Symptoms After BRain Concussion
- Conditions
- Concussion, BrainMild Traumatic Brain Injury
- Registration Number
- NCT06956417
- Lead Sponsor
- University of British Columbia
- Brief Summary
Persistent memory symptoms after concussion are common, and likely perpetuated by unhelpful illness beliefs and coping behaviors. Results from a pilot study suggested that traditional cognitive rehabilitation and a novel cognitive-behavioral therapy (CBT) protocol were both associated with improvements in subjective memory functioning. The present study will more definitively compare the effectiveness of these interventions for improving subjective memory functioning after concussion.
- Detailed Description
The primary research aims of this study are to determine whether cognitive behavioral therapy (CBT) and cognitive compensatory strategy training (CCST) improves subjective memory functioning compared to usual care, and to compare the effectiveness of CBT and CCST. This study is a multisite three-armed randomized control trial (RCT) that will randomize adults with persistent memory symptoms following concussion to CBT, CCST, or a covert waitlist condition (2:2:1). Participants will be blinded to the other arms of the study and the study hypotheses.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 184
- 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
- Fail performance validity testing
- Comorbid psychiatric or neurological disorder or is taking a medication that could fully account for their memory symptoms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Multifactorial Memory Questionnaire-Satisfaction scale 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.
- Secondary Outcome Measures
Name Time Method Fear-Avoidance of Memory Loss Scale 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.
Patient Global Impression of Change scale 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.
Work and Social Adjustment Scale 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.
Trial Locations
- Locations (9)
Calgary Brain Injury Program
🇨🇦Calgary, Alberta, Canada
Fraser Health Acquired Brain Injury and Concussion Services
🇨🇦Langley, British Columbia, Canada
G.F. Strong Adult Concussion Services
🇨🇦Vancouver, British Columbia, Canada
Integrated Adult Concussion Program at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
360 Concussion Care Clinic
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Traumatic Brain Injury Clinic
🇨🇦Toronto, Ontario, Canada
Head Injury Clinic at St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Hull-Ellis Concussion and Research Clinic at University Health Network
🇨🇦Toronto, Ontario, Canada
Canadian Concussion Centre at Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada