Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-02 @ 4:18 AM
Study NCT ID:
NCT05408832
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2022-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Trials for Stress Management Against Standard of Care
Sponsor:
Northwell Health
Organization:
Study Overview
Official Title:
Re-engineering Precision Therapeutics Through N-of-1 Trials: Personalized Trials for Stress Management Against Standard of Care
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The purpose of this study is to determine if an N-of-1 (within-subject, single N, cross-over trial) study design, or what the investigators are calling "Personalized Trials" can improve health outcomes over standard practice for common stress management techniques, and can have widespread use in future research and clinical practice to address high public health burdens with a high heterogeneity of treatment response. This study is informed by three previously conducted feasibility pilots of methods to remotely implement Personalized Trials. This current study uses three different stress management interventions to improve individual self-report of perceived stress: guided mindfulness meditation, guided yoga, and guided brisk walking. Participants randomized to Arm 1 (N=53) and Arm 2 (N=53) will receive Personalized Trials stress management interventions (with arms receiving different order of interventions), whereas participants randomized to Arm 3 (N=106) will receive interventions but will not be required to follow the Personalized Trials format. All participants will begin with a 2-week run-in period, where no stress management interventions are given, but data are collected, including daily surveys and Fitbit-derived sleep and activity data, to obtain a baseline average for later statistical comparison. After successful completion of the baseline period, participants will be randomized to receive either one of two orders of 12-weeks of a Personalized Trial or self-directed (standard care) experience, where they can test 3 different stress management techniques in any order they choose while continuing to answer daily assessments and wearing their Fitbit device. At the end of the 12 weeks, all participants will continue to answer daily surveys and wear their Fitbit device for 2 weeks with no experimenter provided intervention, while the study team creates a report containing the individual's observed data. This report will be sent to each participant in all arms, and participants will have the opportunity to select one stress management technique to continue with for 2 additional weeks. After selection, participants will receive six additional sessions of their chosen treatment and will be observed for engagement in these additional wellness sessions. Participants will also be asked to complete daily survey assessments and Fitbit wear for these two additional weeks. At the end of the 18-week study, a final survey will be sent assessing satisfaction with the study. A random sample of 10% of participants from each arm will be asked to participate in a qualitative interview to discuss their experiences.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01LM012836 | NIH | None | https://reporter.nih.gov/quic… | View |