Pilot feasibility randomised controlled trial of cognitive-behavioural therapy for functional cognitive disorder after concussion.

Background: Functional cognitive disorder (FCD) may be common after a concussion, and no evidence-based treatment options are available. The current study evaluated the feasibility of a novel cognitive-behavioural therapy (CBT) protocol tailored to FCD after concussion.
Methods: Participants were randomised to CBT (n=11) or the current standard of care, cognitive rehabilitation (n=13). Both interventions consisted of eleven 50 min manualised videoconference sessions. CBT involved cognitive reappraisal and exposure-based strategies. Cognitive rehabilitation involved traditional memory compensation strategy training. Prespecified feasibility criteria were set for recruitment, perceived credibility, patient adherence, therapist protocol compliance and retention. The primary efficacy outcome was the Multifactorial Memory Questionnaire-Satisfaction (MMQ-S). The first five CBT completers completed a semistructured interview about their experience with the intervention.
Results: Most feasibility benchmarks were met, as 86% of invited patients consented, 96% of participants rated their intervention as credible, participants attended 96% of sessions, therapists covered all essential content in 94% of sessions and 100% of participants completed the post-treatment evaluation. Both groups improved on the MMQ-S. Post-treatment MMQ-S scores were similar between groups (Cohen's d=-0.05 (95% CI [-0.86, 0.75])). Two themes resulted from the qualitative data analysis, which highlighted aspects of the CBT interventions that participants valued.
Implications: This pilot trial supports the feasibility of CBT tailored to FCD after concussion and suggests that patients with FCD may benefit from either CBT or standard cognitive rehabilitation. A larger trial is needed to evaluate the efficacy of these interventions for FCD after concussion and potentially FCD in other clinical contexts.
Trial Registration Number: NCT05581810.
Competing Interests: JL received a Michael Smith Scholar Award. DLP has received honoraria for continuing medical education lectures; royalties from Springer for a textbook and honoraria from Elsevier for another textbook; is on the editorial boards of Brain and Behavior (paid), Epilepsy & Behavior, The Journal of Neuropsychiatry and Clinical Neurosciences, and Cognitive and Behavioral Neurology; receives funding from the Sidney R. Baer Jr. Foundation and NIH unrelated to this work and is on the FND Society Board, American Neuropsychiatric Association Advisory Council and the FND Hope International Medical Advisory Board. NDS has received research funding from the Canadian Institutes of Health Research, Canada Foundation for Innovation, Ontario Brain Institute, Weston Brain Institute and VGH+UBC Hospital Foundation. He has also received honoraria for continuing medical education lectures.
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