Rehabilitation for Functional Memory Symptoms After Concussion
- Conditions
- Functional Neurological DisorderMild Traumatic Brain Injury
- Interventions
- Behavioral: Cognitive Behavioural Therapy (CBT)Behavioral: Cognitive Rehabilitation
- Registration Number
- NCT05581810
- Lead Sponsor
- University of British Columbia
- Brief Summary
This study aims to evaluate the feasibility of novel cognitive behavioural therapy (CBT)-based intervention designed to improve functional memory symptoms after concussion. Participants will be randomized to CBT or an attention-matched control intervention (cognitive rehabilitation). The primary outcomes for this trial are feasibility metrics, including recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention.
- Detailed Description
Background: Although objectively measurable memory impairments typically resolve within weeks after sustaining a concussion, many people continue to perceive memory problems one year later. There are no known effective treatments for this condition. A promising new approach may be to target psychological mechanisms that perpetuate excessively negative perceptions of memory ability.
Methods: A pilot randomized controlled trial to evaluate the feasibility of a new cognitive behavioural therapy (CBT)-based treatment program specifically designed to improve persistent memory complaints after concussion. The main inclusion criteria will be (i) concussion in the past 6 to 24 months, (ii) research diagnosis of Functional Cognitive Disorder. Participants will be randomized (1:1) into one of two groups: CBT or cognitive rehabilitation. Individuals in both groups will participate in 11 x 50-minute sessions delivered over Zoom videoconference, co-facilitated by clinical psychology graduate students under the supervision of a registered clinical psychologist.
Aims: To evaluate the feasibility and potential efficacy of CBT for functional memory symptoms after concussion.
Approach: Prespecified feasibility criteria on recruitment, patient-perceived credibility of treatment, patient adherence to treatment, therapists' compliance with the treatment protocol, and retention will determine the success of the pilot trial. The investigators further hypothesize that CBT will be associated with greater reductions in memory concern compared to the control intervention.
Implications: The results of this pilot study will inform a larger, more definitive clinical trial focused on testing efficacy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Age 18-65 years old
- Fluent in English
- Have regular access to the internet
- Sustained a concussion according to the World Health Organization Neurotrauma Task Force definition between 6 and 24 months ago
- Meet diagnostic criteria for Functional Cognitive Disorder
- Performance validity test failure
- Unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.),
- Unstable severe/mental illness (e.g., schizophrenia requiring hospital admission in the past year)
- Probable alcohol or drug use disorder
- Taking a medication with a known side effect of memory impairment (e.g., benzodiazepines, opiates, or topiramate)
- Contraindication(s) for MRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behavioural Therapy (CBT) Cognitive Behavioural Therapy (CBT) 11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference Cognitive Rehabilitation Cognitive Rehabilitation 11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference
- Primary Outcome Measures
Name Time Method Therapists compliance Week 12 Therapists cover 95% of essential element content
Patient adherence Week 12 \>70% of participants attend at least 8 sessions
Memory concern Week 12 Satisfaction subscale of the Multifactorial Memory Questionnaire \[range=0-72; higher scores indicate greater satisfaction with memory\]
Recruitment Week 0 \>50% of eligible participants agree to enroll
Treatment credibility Week 2 \>50% of enrolled participants rate the intervention as above midpoint on credibility
Retention Week 12 \>80% of randomized participants complete the primary outcome measure immediately post-intervention
- Secondary Outcome Measures
Name Time Method Avoidance Week 12 Fear-Avoidance of Memory Loss Scale \[range=5-25; higher scores indicate greater fear and avoidance\]
Patient Global Impression of Change Week 12 Single item rated on a scale of 1 (much worse) to 5 (much better) since the start of treatment
Catastrophizing Week 12 Adapted Pain Catastrophizing Scale \[range=0-52, higher scores indicate greater catastrophizing\]
Reliance on others Week 12 Relative subscale of the Memory Compensation Questionnaire \[range=0-115; higher scores indicate greater dependence on others to remember things\]
Trial Locations
- Locations (10)
Richmond Hospital
🇨🇦Richmond, British Columbia, Canada
Urgent and Primary Care Center: North Vancouver
🇨🇦North Vancouver, British Columbia, Canada
Lion's Gate Hosital
🇨🇦North Vancouver, British Columbia, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
University of British Columbia Hospital
🇨🇦Vancouver, British Columbia, Canada
Back in Motion (Post-Concussion Management Program)
🇨🇦Surrey, British Columbia, Canada
Mount Saint Joseph's Hospital
🇨🇦Vancouver, British Columbia, Canada
Lifemark (Post-Concussion Management Program)
🇨🇦Vancouver, British Columbia, Canada
Urgent and Primary Care Center: City Center
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada