Rehabilitation for Functional Memory Symptoms After Concussion

University of British Columbia

Status: Completed

Conditions: Mild Traumatic Brain Injury; Functional Neurological Disorder

Treatments: Behavioral: Cognitive Behavioural Therapy (CBT); Behavioral: Cognitive Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05581810

H22-00436

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Cognitive Behavioural Therapy (CBT)

Experimental group

Description:

11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference

Treatment:

Behavioral: Cognitive Behavioural Therapy (CBT)

Cognitive Rehabilitation

Active Comparator group

Description:

11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference

Treatment:

Behavioral: Cognitive Rehabilitation