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NCT05408832 · ClinicalTrials.gov registry record · Phase 2
Personalized Trials for Stress Management Against Standard of Care
A Phase 2 study of Stress, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 212
- Enrollment target
- 1
- Study location
NCT05408832: Completed Phase 2 study of Stress, sponsored by Northwell Health.
NCT05408832 is a Phase 2 study of Stress that has completed, run by Northwell Health. The registered enrollment target is 212 participants, below the 785-participant average among 152 other Stress trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05408832, a Phase 2 study of Stress, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 212 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Stress will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their stress on a scale of 0 (low) to 10 (high). Levels of EMA stress will be aggregated within the baseline assessment period and during the follow-up period to generate an overall mean and standard deviation for each period. The change in EMA stress between baseline and follow-up will be calculated by subtracting these aggregated means. The difference in change in EMA str
Conditions Studied
Interventions
- BEHAVIORAL Personalized Trial ABCCBA
- BEHAVIORAL Personalized Trial CBAABC
- BEHAVIORAL Stress Management Techniques with No Randomization Sequence (or order)
Study Locations (1)
New York
- Institute of Health System Science - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2024-01-08 |
| Phase | Phase 2 |
What the finished NCT05408832 record still lists
NCT05408832 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, below the 785-participant average among 152 other Stress trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Stress appearing as the primary indexed condition, and to 3 interventions - of which Personalized Trial ABCCBA is the first listed.
NCT05408832 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05408832 about?
NCT05408832 is a clinical study titled "Personalized Trials for Stress Management Against Standard of Care". 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 interve...
What is the current status of trial NCT05408832?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 212 participants. The study started on 2022-06-23. Estimated completion is 2024-01-08.
What conditions does trial NCT05408832 study?
This clinical trial studies the following conditions: Stress.
What interventions are being tested in trial NCT05408832?
The interventions under investigation include: Personalized Trial ABCCBA (BEHAVIORAL), Personalized Trial CBAABC (BEHAVIORAL), Stress Management Techniques with No Randomization Sequence (or order) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05408832?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05408832 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05408832's enrollment target sits among peer trials
212 28th of 152 higher than 125 of 152 other Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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