Rehabilitation for Functional Memory Symptoms After Concussion

Last updated: December 3, 2024
Sponsor: University of British Columbia
Overall Status: Completed

Phase

N/A

Condition

Hypochondriasis

Brain Injury

Neurologic Disorders

Treatment

Cognitive Rehabilitation

Cognitive Behavioural Therapy (CBT)

Clinical Study ID

NCT05581810
H22-00436
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 TaskForce definition between 6 and 24 months ago

  • Meet diagnostic criteria for Functional Cognitive Disorder

Exclusion

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 inthe 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

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Cognitive Rehabilitation
Phase:
Study Start date:
November 29, 2022
Estimated Completion Date:
November 30, 2023

Study 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.

Connect with a study center

  • Lion's Gate Hosital

    North Vancouver, British Columbia V7L 2L7
    Canada

    Site Not Available

  • Urgent and Primary Care Center: North Vancouver

    North Vancouver, British Columbia V7L 1A5
    Canada

    Site Not Available

  • Richmond Hospital

    Richmond, British Columbia V6X 1A2
    Canada

    Site Not Available

  • Back in Motion (Post-Concussion Management Program)

    Surrey, British Columbia V3W 5A8
    Canada

    Site Not Available

  • Lifemark (Post-Concussion Management Program)

    Vancouver, British Columbia V6B 6C1
    Canada

    Site Not Available

  • Mount Saint Joseph's Hospital

    Vancouver, British Columbia V5T 3N4
    Canada

    Site Not Available

  • St. Paul's Hospital

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

  • University of British Columbia Hospital

    Vancouver, British Columbia V6T 2B5
    Canada

    Site Not Available

  • Urgent and Primary Care Center: City Center

    Vancouver, British Columbia V6Z 0A3
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

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