Rehabilitation for Functional Memory Symptoms After Concussion

Feasibility of Cognitive Behavioural Therapy for Functional Memory Symptoms After Concussion

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.

Study Overview

• Status: Completed
• Conditions: Mild Traumatic Brain Injury; Functional Neurological Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy (CBT); Behavioral: Cognitive Rehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • North Vancouver, British Columbia, Canada, V7L 1A5
      • Urgent and Primary Care Center: North Vancouver
    • North Vancouver, British Columbia, Canada, V7L 2L7
      • Lion's Gate Hosital
    • Richmond, British Columbia, Canada, V6X 1A2
      • Richmond Hospital
    • Surrey, British Columbia, Canada, V3W 5A8
      • Back in Motion (Post-Concussion Management Program)
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V6T 2B5
      • University of British Columbia Hospital
    • Vancouver, British Columbia, Canada, V5T 3N4
      • Mount Saint Joseph's Hospital
    • Vancouver, British Columbia, Canada, V6Z 0A3
      • Urgent and Primary Care Center: City Center
    • Vancouver, British Columbia, Canada, V6B 6C1
      • Lifemark (Post-Concussion Management Program)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioural Therapy (CBT); 11 weekly sessions of cognitive behavioural therapy (CBT) delivered over videoconference	Behavioral: 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.
Active Comparator: Cognitive Rehabilitation; 11 weekly sessions of traditional cognitive rehabilitation delivered over videoconference	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Harvard Medical School (HMS and HSDM)
• Investigators: Principal Investigator: Noah Silverberg, PhD, University of British Columbia

Publications and helpful links

General Publications

• Rioux M, Mamman R, Byworth MT, Panenka WJ, Howard AK, Perez DL, Schmidt J, Courchesne C, LeMoult J, Heran MK, Silverberg ND. Pilot feasibility randomised controlled trial of cognitive-behavioural therapy for functional cognitive disorder after concussion. BMJ Neurol Open. 2024 Oct 11;6(2):e000666. doi: 10.1136/bmjno-2024-000666. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Concussion; Functional Cognitive Disorder
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Mental Disorders; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Personality Disorders; Somatoform Disorders; Histrionic Personality Disorder; Brain Injuries, Traumatic; Brain Injuries; Brain Concussion; Nervous System Diseases; Conversion Disorder; Hysteria
• Other Study ID Numbers: H22-00436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request
• IPD Sharing Time Frame: 12 months after publication
• IPD Sharing Access Criteria: Defined research question approved by the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No