Protocol for randomized personalized trial for stress management compared to standard of care.
Ashley M Goodwin, Danielle Miller, Stefani D'Angelo, Alexandra Perrin, Ruby Wiener, Brittney Greene, Anne-Marie N Romain, Lindsay Arader, Thevaa Chandereng, Ying Kuen Cheung, Karina W Davidson, Mark Butler
Frontiers in Psychology September 19, 2023 DOI: 10.3389/fpsyg.2023.1233884 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Clinical protocol Randomized Peer reviewed |
|---|---|
| Interventions | Guided mindfulness meditation Guided yoga Guided brisk walking |
| Duration | 18 weeks total: 2-week baseline, 12-week intervention period, 2-week observation, and 2 additional weeks of a self-chosen intervention |
| Topics | Meditation |
| Keywords | Yoga Physical activity N-of-1 Stress management techniques Personalized trials |
| Registration | NCT05408832 |
| Key points | The protocol proposes that personalized (N-of-1) trials can help identify which stress management technique works best for an individual, and it outlines a randomized comparison of a personalized approach versus standard of care using guided mindfulness meditation, guided yoga, and guided brisk walking, with the primary analysis comparing perceived stress levels between arms. |
Abstract
Stress is a significant public health burden in the United States, with most Americans reporting unhealthy levels of stress. Stress management techniques include various evidence-based treatments shown to be effective but with heterogeneous treatment responses, indicating a lack of uniform benefits for all individuals. Designed to assess a participant's response to a specific intervention, personalized (N-of-1) trials provide guidance for which treatment (s) work (s) best for the individual. Prior studies examining the effects of mindfulness meditation, yoga, and walking for stress reduction found all three interventions to be associated with significant reductions in self-reported measures of stress. Delivering these treatments using a personalized trial approach has the potential to assist clinicians in identifying the best stress management techniques for individuals with persistently high stress while fostering treatment decisions that consider their personal condition/barriers. This trial will evaluate a personalized approach compared to standard of care for three interventions (guided mindfulness meditation; guided yoga; and guided brisk walking) to manage perceived stress. Participants will respond to daily surveys and wear a Fitbit device for 18 weeks. After a 2-week baseline period, participants in the personalized trial groups will receive 12 weeks of interventions in randomized order, while participants in the standard-of-care group will have access to all interventions for self-directed stress management. After intervention, all participants will undergo 2 weeks of observation, followed by two additional weeks of the stress management intervention of their choosing while continuing outcome measurement. At study completion, all participants will be sent a satisfaction survey. The primary analysis will compare perceived stress levels between the personalized and standard of care arms. The results of this trial will provide further support for the use of personalized designs for managing stress. Clinical Trial Registration: clinicaltrials.gov, NCT05408832. Protocol version: 9/14/2022, 21-0968-MRB.