Functional Neurological Disorder, Mild Traumatic Brain Injury
Conditions
Keywords
Concussion, Functional Cognitive Disorder
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALCognitive Rehabilitation
Training and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223.
Sponsors
Harvard Medical School (HMS and HSDM)
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Memory concern | Week 12 | Satisfaction subscale of the Multifactorial Memory Questionnaire \[range=0-72; higher scores indicate greater satisfaction with memory\] |
| Treatment credibility | Week 2 | \>50% of enrolled participants rate the intervention as above midpoint on credibility |
| Patient adherence | Week 12 | \>70% of participants attend at least 8 sessions |
| Therapists compliance | Week 12 | Therapists cover 95% of essential element content |
| Retention | Week 12 | \>80% of randomized participants complete the primary outcome measure immediately post-intervention |
| Recruitment | Week 0 | \>50% of eligible participants agree to enroll |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reliance on others | Week 12 | Relative subscale of the Memory Compensation Questionnaire \[range=0-115; higher scores indicate greater dependence on others to remember things\] |
| Catastrophizing | Week 12 | Adapted Pain Catastrophizing Scale \[range=0-52, higher scores indicate greater catastrophizing\] |
| Patient Global Impression of Change | Week 12 | Single item rated on a scale of 1 (much worse) to 5 (much better) since the start of treatment |
| Avoidance | Week 12 | Fear-Avoidance of Memory Loss Scale \[range=5-25; higher scores indicate greater fear and avoidance\] |
Countries
Canada
Outcome results
None listed