Rehabilitation for Functional Memory Symptoms After Concussion

Mild Traumatic Brain Injury Clinical Trial

Official title:

Feasibility of Cognitive Behavioural Therapy for Functional Memory Symptoms After Concussion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05581810
• Other study ID #: H22-00436
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Conversion Disorder
• Functional Neurological Disorder
• Mild Traumatic Brain Injury
• Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Lion's Gate Hosital	North Vancouver	British Columbia
Canada	Urgent and Primary Care Center: North Vancouver	North Vancouver	British Columbia
Canada	Richmond Hospital	Richmond	British Columbia
Canada	Back in Motion (Post-Concussion Management Program)	Surrey	British Columbia
Canada	Lifemark (Post-Concussion Management Program)	Vancouver	British Columbia
Canada	Mount Saint Joseph's Hospital	Vancouver	British Columbia
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	University of British Columbia Hospital	Vancouver	British Columbia
Canada	Urgent and Primary Care Center: City Center	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	>50% of eligible participants agree to enroll	Week 0
Primary	Treatment credibility	>50% of enrolled participants rate the intervention as above midpoint on credibility	Week 2
Primary	Patient adherence	>70% of participants attend at least 8 sessions	Week 12
Primary	Therapists compliance	Therapists cover 95% of essential element content	Week 12
Primary	Retention	>80% of randomized participants complete the primary outcome measure immediately post-intervention	Week 12
Primary	Memory concern	Satisfaction subscale of the Multifactorial Memory Questionnaire [range=0-72; higher scores indicate greater satisfaction with memory]	Week 12
Secondary	Avoidance	Fear-Avoidance of Memory Loss Scale [range=5-25; higher scores indicate greater fear and avoidance]	Week 12
Secondary	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
Secondary	Catastrophizing	Adapted Pain Catastrophizing Scale [range=0-52, higher scores indicate greater catastrophizing]	Week 12
Secondary	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