Phase 2
N=212
Personalized Trials for Stress Management Against Standard of Care
Stress
Bottom Line
View on ClinicalTrials.gov: NCT05408832 ↗Enrolled (actual)
212
Serious AEs
0.3%
Results posted
Mar 2026
Primary outcome: Primary: Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress. — -0.50; -0.31 units on a scale — p=.316
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Personalized Trial ABCCBA (Behavioral); Personalized Trial CBAABC (Behavioral); Stress Management Techniques with No Randomization Sequence (or order) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress. |
-0.50; -0.31 | .316 |
| SECONDARY Change in Mean Within-Subject Difference in Weekly Perceived Stress. |
-0.12; -.14 | 0.964 |
| SECONDARY Agreement of Intervention Selection Between Participant and Researcher. |
18; 10; 6; 14; 18; 15 | — |
| SECONDARY Mean System Usability Score (SUS). |
82.69; 79.8 | — |
| SECONDARY Participant Satisfaction With Personalized Trial Components. |
4.19; 4.04; 4.23; 4.2; 3.84; 3.7 | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress. |
-.26; -.24; -.25 | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue. |
-.46; -.43; -.49 | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain. |
.13; .09; .13 | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood. |
.39; .42; .34 | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration. |
.18; .19; .07 | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence. |
.29; .33; .18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05408832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.