Clinical trial NCT05581810: Rehabilitation for Functional Memory Symptoms After Concussion
Official title: Feasibility of Cognitive Behavioural Therapy for Functional Memory Symptoms After Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Functional Neurological Disorder
Keywords: Concussion
Functional Cognitive Disorder
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2022-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: Week 0
measure: Treatment credibility
timeFrame: Week 2
measure: Patient adherence
timeFrame: Week 12
measure: Therapists compliance
timeFrame: Week 12
measure: Retention
timeFrame: Week 12
measure: Memory concern
timeFrame: Week 12
Secondary outcomes:
measure: Avoidance
timeFrame: Week 12
measure: Reliance on others
timeFrame: Week 12
measure: Catastrophizing
timeFrame: Week 12
measure: Patient Global Impression of Change
timeFrame: Week 12
Other outcomes:
Locations:
city: North Vancouver
country: Canada
facility: Urgent and Primary Care Center: North Vancouver
state: British Columbia
city: North Vancouver
country: Canada
facility: Lion's Gate Hosital
state: British Columbia
city: Richmond
country: Canada
facility: Richmond Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Back in Motion (Post-Concussion Management Program)
state: British Columbia
city: Vancouver
country: Canada
facility: Mount Saint Joseph's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Lifemark (Post-Concussion Management Program)
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Urgent and Primary Care Center: City Center
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Noah Silverberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.