Strategy-based cognitive intervention for Parkinson disease: A pilot randomizedcontrolled trial

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PROJECT SUMMARY/ABSTRACT The long term goal of this work is to reduce disability among people with Parkinson disease (PD) by enabling them to cope with cognitive decline so they can perform and participate in desired activities and roles. PD is the second most prevalent neurodegenerative disease, affecting over 1 million Americans and causing considerable personal and socioeconomic costs that are expected to rise as the population ages. Cognitive impairment produces significant disability and reduced quality of life among non-demented people with PD. Unfortunately, existing medical (i.e. surgical and pharmacological) treatments for PD do not prevent, treat, or mitigate the negative functional consequences of cognitive impairment. As such, the development of new, effective cognitive rehabilitation treatments for PD is a top research priority. The investigators have developed a novel, individualized, strategy training intervention to attenuate cognitive decline and improve or maintain daily function in PD (Strategy Training for Transfer, STRAIT). It involves teaching people to use targeted compensatory or adaptive strategies in everyday life to work around or through cognitive challenges and achieve functional goals. Strategy training is a practice standard for cognitive rehabilitation in brain injury and stroke, but its application in PD is novel. Furthermore, STRAIT incorporates specific evidence-based training techniques to support the transfer of strategy use and its benefits to real-world activities and contexts. This explicit focus on generalization to daily function is critically lacking in cognitive rehabilitation approaches for people with PD to-date. The current project objective is to test and optimize the intervention and study procedures for future clinical trials and eventual translation into clinical practice. The study design is a single- blind pilot randomized controlled trial (RCT) comparing STRAIT to a standard-of-care control (task-oriented cognitive training). The research plan has three specific aims: Aim 1 will examine general feasibility (e.g. recruitment, retention), Aim 2 will examine participant- and therapist-related aspects of treatment fidelity, and Aim 3 will generate preliminary estimates of STRAIT’s effect on daily function to inform sample size calculations for a definitive RCT. The results from this study will directly inform an R01 application for an RCT to test STRAIT’s efficacy and/or effectiveness. It will also provide the investigators with critical data, experience, and infrastructure to facilitate future efficiency, rigor, and reproducibility in clinical trials and dissemination and implementation in real-world clinical practice. This work will meet the pressing need for effective cognitive interventions for people with PD and will ultimately positively impact function and quality of life in this population.