Rehabilitation for Functional Memory Symptoms After Concussion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of Cognitive Behavioural Therapy for Functional Memory Symptoms After Concussion

Conditions
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Mild Traumatic Brain Injury, Functional Neurological Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy (CBT)
* Behavioral: Cognitive Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioural Therapy (CBT)<br>11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference | Behavioral: Cognitive Behavioural Therapy (CBT)<br>* Cognitive behavioural therapy for functional memory symptoms after concussion is delivered by a psychologist over 11 individual (1:1) secure videoconference sessions. The core active ingredients are 1) Behavioural experiments, which acts by phasing out compensatory strategies in order to increase normal memory use and 2) Cognitive reappraisal, which aids in re-interpreting memory lapses in order to reduce reactivity to them.<br>|
| Active Comparator: Cognitive Rehabilitation<br>11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference | Behavioral: Cognitive Rehabilitation<br>* Training and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | >50% of eligible participants agree to enroll | Week 0 | 
| Treatment credibility | >50% of enrolled participants rate the intervention as above midpoint on credibility | Week 2 | 
| Patient adherence | >70% of participants attend at least 8 sessions | Week 12 | 
| Therapists compliance | Therapists cover 95% of essential element content | Week 12 | 
| Retention | >80% of randomized participants complete the primary outcome measure immediately post-intervention | Week 12 | 
| Memory concern | Satisfaction subscale of the Multifactorial Memory Questionnaire [range=0-72; higher scores indicate greater satisfaction with memory] | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Avoidance | Fear-Avoidance of Memory Loss Scale [range=5-25; higher scores indicate greater fear and avoidance] | Week 12 | 
| Reliance on others | Relative subscale of the Memory Compensation Questionnaire [range=0-115; higher scores indicate greater dependence on others to remember things] | Week 12 | 
| Catastrophizing | Adapted Pain Catastrophizing Scale [range=0-52, higher scores indicate greater catastrophizing] | Week 12 | 
| Patient Global Impression of Change | Single item rated on a scale of 1 (much worse) to 5 (much better) since the start of treatment | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion, Functional Cognitive Disorder