Rehabilitation for Functional Memory Symptoms After Concussion

University of British Columbia30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Mild Traumatic Brain Injury Functional Neurological Disorder

Interventions

Cognitive Behavioural Therapy (CBT)BEHAVIORAL

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.

Cognitive RehabilitationBEHAVIORAL

Training and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (10)

Urgent and Primary Care Center: North Vancouver

North Vancouver, British Columbia, Canada

Lion's Gate Hosital

North Vancouver, British Columbia, Canada

Richmond Hospital

Richmond, British Columbia, Canada

Outcomes

Primary Outcomes

Recruitment

\>50% of eligible participants agree to enroll

Time frame: Week 0

Treatment credibility

\>50% of enrolled participants rate the intervention as above midpoint on credibility

Time frame: Week 2

Patient adherence

\>70% of participants attend at least 8 sessions

Time frame: Week 12

Therapists compliance

Therapists cover 95% of essential element content

Time frame: Week 12

Retention

\>80% of randomized participants complete the primary outcome measure immediately post-intervention

Time frame: Week 12

Memory concern

Satisfaction subscale of the Multifactorial Memory Questionnaire \[range=0-72; higher scores indicate greater satisfaction with memory\]

Time frame: Week 12

Secondary Outcomes

Avoidance

Fear-Avoidance of Memory Loss Scale \[range=5-25; higher scores indicate greater fear and avoidance\]

Time frame: Week 12

Reliance on others

Relative subscale of the Memory Compensation Questionnaire \[range=0-115; higher scores indicate greater dependence on others to remember things\]

Time frame: Week 12

Data from ClinicalTrials.gov

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