NCT Number: NCT05581810
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Lion's Gate Hosital, North Vancouver, British Columbia, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Training and practice with external memory aids/compensatory strategies, adapted from Shum et al. (2011). J Rehabil Med, 43(3):216-223.
Time frame: Week 0
>50% of eligible participants agree to enroll
Time frame: Week 2
>50% of enrolled participants rate the intervention as above midpoint on credibility
Time frame: Week 12
>70% of participants attend at least 8 sessions
Time frame: Week 12
Therapists cover 95% of essential element content
Time frame: Week 12
>80% of randomized participants complete the primary outcome measure immediately post-intervention
Time frame: Week 12
Satisfaction subscale of the Multifactorial Memory Questionnaire [range=0-72; higher scores indicate greater satisfaction with memory]
Time frame: Week 12
Fear-Avoidance of Memory Loss Scale [range=5-25; higher scores indicate greater fear and avoidance]
Time frame: Week 12
Relative subscale of the Memory Compensation Questionnaire [range=0-115; higher scores indicate greater dependence on others to remember things]
Time frame: Week 12
Adapted Pain Catastrophizing Scale [range=0-52, higher scores indicate greater catastrophizing]
Time frame: Week 12
Single item rated on a scale of 1 (much worse) to 5 (much better) since the start of treatment
University of British Columbia
Other
Feasibility of Cognitive Behavioural Therapy for Functional Memory Symptoms After Concussion
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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