Mindfulness Training for Depressed Older Adults Using Smartphone Technology: Protocol for a Fully Remote Precision Clinical Trial.

BACKGROUND: Precision medicine, optimized interventions, and access to care are catchphrases for the future of behavioral treatments. Progress has been slow due to the dearth of clinical trials that optimize interventions' benefits, individually tailor interventions to meet individual needs and preferences, and lead to rapid implementation after effectiveness is demonstrated. Two innovations have emerged to meet these challenges: fully remote trials and precision clinical trials. OBJECTIVE: This paper provides a detailed description of Mindful MyWay, a study designed to test online mindfulness training in older adults with depression. Consistent with the concept of fully remote trials using a smartphone app, the study requires no in-person contact and can be conducted with participants anywhere in the United States. Based upon the precision medicine framework, the study assesses participants using high-frequency assessments of symptoms, cognitive performance, and patient preferences to both understand the individualized nature of treatment response and help individually tailor the intervention. METHODS: Mindful MyWay is an open-label early-phase clinical trial for individuals 65 years and older with current depression. A smartphone app was developed to help coordinate the study, deliver the intervention, and evaluate the acceptability of the intervention, as well as predictors and outcomes of it. The curriculum for the fully remote intervention parallels the mindfulness-based stress reduction curriculum, a protocolized group-based mindfulness training that is typically provided in person. After consent and screening, participants download The Healthy Mind Lab mobile health smartphone app from the Apple App Store, allowing them to complete brief smartphone-based assessments of depressive symptoms and cognitive performance 4 times each day for 4 weeks prior to and after completing the intervention. The intervention consists of an introduction video and 10 weekly mindfulness training sessions, with the expectation to practice mindfulness at home daily. The app collects participant preference data throughout the 10-week intervention period; these high-frequency assessments identify participants' individually dynamic preferences toward the goal of optimizing the intervention in future iterations. RESULTS: Participant recruitment and data collection began in March 2019. Final end point assessments will be collected in May 2022. The paper describes lessons learned regarding the critical role of early-phase testing prior to moving to a randomized trial. CONCLUSIONS: The Mindful MyWay study is an exemplar of innovative clinical trial designs that use smartphone technology in behavioral and neuropsychiatric conditions. These include fully remote studies that can recruit throughout the United States, including hard-to-access areas, and collect high-frequency data, which is ideal for idiographic assessment and individualized intervention optimization. Our findings will be used to modify our methods and inform future randomized controlled trials within a precision medicine framework. TRIAL REGISTRATION: ClinicalTrials.gov NCT03922217; https://clinicaltrials.gov/ct2/show/NCT03922217. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39233.

Awake High-Flow Extracranial to Intracranial Bypass for Complex Cerebral Aneurysms: Institutional Clinical Trial Results.

OBJECTIVE: Assess the potential added benefit to patient outcomes of "awake" neurological testing when compared with standard neurophysiologic testing performed under general endotracheal anesthesia. METHODS: Prospective study of 30 consecutive adult patients who underwent awake high flow extracranial to intracranial (HFEC-IC) bypass. Clinical neurological and neurophysiologic findings were recorded. Primary outcome measures were the incidence of stroke/cerebrovascular accident (CVA), length of stay, discharge to rehabilitation, 30-day modified Rankin scale score, and death. An analysis was also performed of a retrospective control cohort (n = 110 patients who underwent HFEC-IC for internal carotid artery (ICA) aneurysms under standard general endotracheal anesthesia). RESULTS: Five patients (16.6%) developed clinical awake neurological changes (4, contralateral hemiparesis; 1, ipsilateral visual changes) during the 10-minute ICA occlusion test. These patients had 2 kinks in the graft, 1 vasospasm, 1 requiring reconstruction of the distal anastomosis, and 1 developed blurring of vision that reversed after the removal of the distal permanent clip on the ICA. Three of these 5 patients had asynchronous clinical "awake" neurological and neurophysiologic changes. Two patients (7%) developed CVA. Median length of stay was 4 days. Twenty-eight of 30 patients were discharged to home. Median modified Rankin scale score was 1. There were no deaths in this series. Absolute risk reduction in the awake craniotomy group (n = 30) relative to control retrospective group (n = 110) was 7% for CVA, 9% for discharge to rehabilitation, and 10% for graft patency. CONCLUSIONS: Temporary ICA occlusion during HFEC-IC bypass for ICA aneurysms in conjunction with awake intraoperative clinical testing was effective in detecting a subset of patients (n = 3, 10%) in whom neurological deficit was not detected by neurophysiologic monitoring alone.