Rehabilitation for Functional Memory Symptoms After Concussion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-29

Study Completion Date

2023-11-30

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.

Conditions

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Mild Traumatic Brain Injury Functional Neurological Disorder

Keywords

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Concussion Functional Cognitive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Participants will be blinded to their group assignment and treatment arms, but not to the type of intervention they are receiving. It is not possible to blind study therapists, as they have to administer the therapy.

Study Groups

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Cognitive Behavioural Therapy (CBT)

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

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy (CBT)

Intervention Type 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 Rehabilitation

11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference

Group Type ACTIVE_COMPARATOR

Cognitive Rehabilitation

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Behavioural Therapy (CBT)

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.

Intervention Type BEHAVIORAL

Cognitive Rehabilitation

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Noah Silverberg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noah Silverberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Urgent and Primary Care Center: North Vancouver

North Vancouver, British Columbia, Canada

Site Status

Lion's Gate Hosital

North Vancouver, British Columbia, Canada

Site Status

Richmond Hospital

Richmond, British Columbia, Canada

Site Status