Clinical trial NCT06956417: REhabilitation of MEMory Symptoms After BRain Concussion
Official title: REhabilitation of MEMory Symptoms After BRain Concussion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussion, Brain
Mild Traumatic Brain Injury
Keywords: Functional cognitive disorder
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-59
2. Concussion diagnosis confirmed with structured interview based on American Congress of Rehabilitation Medicine diagnostic criteria
3. Concussion occurred between 6 and 36 months before enrollment
4. Ongoing memory concerns
5. Fluent in English
6. Stable access to a computer, tablet, or smartphone with internet capability

Exclusion Criteria:

1. Fail performance validity testing
2. Comorbid psychiatric or neurological disorder or is taking a medication that could fully account for their memory symptoms

Primary outcomes:
measure: Multifactorial Memory Questionnaire-Satisfaction scale
timeFrame: Week 20
Secondary outcomes:
measure: Fear-Avoidance of Memory Loss Scale
timeFrame: Week 1 and week 20
measure: Patient Global Impression of Change scale
timeFrame: Week 20
measure: Work and Social Adjustment Scale
timeFrame: Week 1 and week 20
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary Brain Injury Program
state: Alberta
city: Langley
country: Canada
facility: Fraser Health Acquired Brain Injury and Concussion Services
state: British Columbia
city: Vancouver
country: Canada
facility: G.F. Strong Adult Concussion Services
state: British Columbia
city: Hamilton
country: Canada
facility: Integrated Adult Concussion Program at Hamilton Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: 360 Concussion Care Clinic
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Traumatic Brain Injury Clinic
state: Ontario
city: Toronto
country: Canada
facility: Head Injury Clinic at St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Hull-Ellis Concussion and Research Clinic at University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Canadian Concussion Centre at Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University of British Columbia
name: Noah D Silverberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rioux M, Mamman R, Byworth MT, Panenka WJ, Howard AK, Perez DL, Schmidt J, Courchesne C, LeMoult J, Heran MK, Silverberg ND. Pilot feasibility randomised controlled trial of cognitive-behavioural therapy for functional cognitive disorder after concussion. BMJ Neurol Open. 2024 Oct 11;6(2):e000666. doi: 10.1136/bmjno-2024-000666. eCollection 2024.