Personalized Trials for Stress Management Against Standard of Care

Completed · Phase 2

Conditions studied: Stress

In brief

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.

Key facts

Study ID

NCT05408832

Run by

Northwell Health

People needed

212

Starts

2022-06-23

Expected to finish

2024-01-08

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥ 18 years
• English speaking
• Self-report of perceived stress raw score of 20 or higher using the Perceived Stress Scale (PSS)
• Owns and can regularly access a smartphone capable of receiving text messages and accessing the internet
• Can regularly wear a Fitbit device
• Lives in the United States

You may not qualify if…

• Age < 18 years old
• Women who are pregnant
• Does not speak English
• Does not own or cannot regularly access a smartphone capable of receiving text messages
• Cannot regularly wear a Fitbit device
• Deemed unable to complete the study protocol as a result of cognitive impairment, severe medical or mental illness, or active or prior substance abuse
• Planned surgeries 6 months from study start date
• Individuals who have been previously told by a doctor to not engage in brisk walking 30 minutes, three times per week
• Individuals who have been previously told by a doctor to not engage in yoga
• Lives outside the United States

Where it is running

• Institute of Health System Science — New York, New York, United States

Full record on ClinicalTrials.gov

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