At a glance
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Re-engineering Precision Therapeutics Through N-of-1 Trials: Personalized Trials for Stress Management Against Standard of Care
In Brief
A Phase 2 clinical trial evaluating Personalized Trial ABCCBA, Personalized Trial CBAABC, and 1 other intervention for Stress. Completed, enrolled 212 participants across 1 site.
Detailed Summary
The purpose of this study is to determine if an N-of-1 study design, or within-subject trials that the investigators are calling "Personalized Trials" can improve health outcomes over standard practice for common stress management techniques. This study uses three different stress management interventions to improve individual self-report of perceived stress: guided mindfulness meditation, guided yoga, and guided brisk walking. Arm 1 (n=53) and Arm 2 (n=53) of the trial will deliver the interventions using a Personalized Trial (within-subject, single N, cross-over trial) format. Participants in Arm 3 of the trial (N=106) will be offered the same number of interventions but will not be required to follow the established N-of-1 Personalized Trials framework. At the end of their Personalized Trial, participants in Arms 1 and 2 will receive a summarized report with personalized feedback. Participants in Arm 3 will also receive a report, but with summarized data . Both arms will receive 2 additional weeks of the stress management intervention of their choosing, while continuing to answer daily assessments and wear a Fitbit device. At the end of the study, a final survey will be sent assessing satisfaction with the study.
Study Details
Timeline
Interventions
Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (ABCCBA), where A=mindfulness meditation, B=yoga, and C=brisk walking.
Participants will receive links for 30-minute videos for all three interventions, for 2 weeks each, 3 times per week, in a specified order (CBAABC), where A=mindfulness meditation, B=yoga, and C=brisk walking.
Participants will have access to all 30-minute videos for A=mindfulness meditation, B=yoga, and C=brisk walking, during the 12-week phase of the study. They will be limited to 12 total views per stress management technique.