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

Abstract

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://ichgcp.net/clinical-trials-registry/NCT03922217.

International registered report identifier (irrid): DERR1-10.2196/39233.

Keywords: adult; aging; clinical trial; death; depressed; depression; fully remote trial; intervention; mHealth; medicine; mind; mindfulness; needs; older; online; precision medicine; preferences; remote; session; smartphone; technology; training; treatment.

Conflict of interest statement

Conflicts of Interest: TRG and JK receive consulting fees from Pritikin ICR. EJL receives grant support (nonfederal) from COVID Early Treatment Fund, Mercatus Center Emergent Ventures, the Skoll Foundation, the Patient-Centered Outcomes Research Institute, and Janssen; consulting fees from IngenioRx, Boehringer-Ingelheim, Merck, Prodeo, and Pritikin ICR; and has applied for a patent for the use of fluvoxamine in the treatment of COVID-19. GEN reported receiving grants from Alkermes, the Center for Brain Research in Mood Disorders, the Center for Diabetes Translational Research, the Institute for Public Health, the McDonnell Center for Neuroscience, and the Barnes Jewish Hospital Foundation, and reported serving as a consultant to Sunovion, Alkermes, and Elira. No other disclosures were reported.

©Abigail Schweiger, Thomas L Rodebaugh, Eric J Lenze, Katie Keenoy, Jason Hassenstab, Jeanne Kloeckner, Torie R Gettinger, Ginger E Nicol. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.10.2022.

Figures

Figure 1

Flowchart indicating the study procedures and mindfulness training intervention phases.

Figure 2

Mindful MyWay app introductory screens. (A) The top row is an example of the introductory screens that allow participants to choose an individualized day and time for their class reminders. (B) The bottom row is an example of ecological momentary assessments sent to the participants 4 times each day.