Personalized Trials for Stress Management Against Standard of Care

Re-engineering Precision Therapeutics Through N-of-1 Trials: 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 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 Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Behavioral: Personalized Trial ABCCBA; Behavioral: Personalized Trial CBAABC; Behavioral: Stress Management Techniques with No Randomization Sequence (or order)

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 Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Institute of Health System Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized Trial ABCCBA; Participants in Arm 1 will receive a Personalized Trial of the 3 stress management interventions in an ABCCBA treatment order, where A=mindfulness meditation, B=yoga, and C=brisk walking. Participants in this arm will be prompted to complete 30-minute stress management sessions during applicable treatment weeks. A link to the stress management video will be delivered via text 3 times per week to the participant during applicable intervention periods in the personalized trial arms. Participants will be limited to three views of study-provided stress management content each week.	Behavioral: Personalized Trial ABCCBA; 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.
Experimental: Personalized Trial CBAABC; Participants in Arm 2 will receive a Personalized Trial of the 3 stress management interventions in a CBAABC treatment order, where A=mindfulness meditation, B=yoga, and C=brisk walking. Participants in this arm will be prompted to complete 30-minute stress management sessions during applicable treatment weeks. A link to the stress management video will be delivered via text 3 times per week to the participant during applicable intervention periods in the personalized trial arms. Participants will be limited to three views of the study-provided stress management content each week.	Behavioral: Personalized Trial CBAABC; 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.
Active Comparator: Standard Care; Participants in Arm 3 will receive Standard Care of the 3 stress management techniques (mindfulness meditation, yoga, and brisk walking). Participants will receive access to the same number of views of the mindfulness meditation, yoga, and brisk walking content given to participants randomized in Arm 1 and Arm 2. However, they will not be prompted to complete any session according to a randomization sequence. A link to the stress management video will be delivered via text 1 time per week to the participant. Participants will be limited to 36 total views of study-provided stress management content (12 total views per stress management technique).	Behavioral: Stress Management Techniques with No Randomization Sequence (or order); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress.	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 stress between baseline and follow-up periods will be compared between the personalized arms (Arm 1 and 2) and the standard of care arm (Arm 3) using a two-sample t-test and Generalized Linear Mixed Model analyses.	EMA stress will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) during follow-up period (13-18 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Within-Subject Difference in Weekly Perceived Stress.	Weekly perceived stress will be assessed with the 10-item Perceived Stress Scale (PSS-10), modified to be delivered to assess the prior week rather than the prior month. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent higher level of stress. Levels of weekly perceived 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 weekly perceived stress between baseline and follow-up will be examined using Generalized Linear Mixed Model analyses.	Perceived stress will be assessed weekly during the baseline assessment period (2 weeks) during follow-up period (13-18 weeks).
Agreement of Intervention Selection Between Participant and Researcher.	At the end of the intervention in the personalized trial arms (Arm 1 & Arm 2), personalized trial data will be used to identify which intervention (mindfulness, yoga, or walking) was most effective at reducing stress. This recommendation will be presented in a personalized report sent after completion of the intervention. The number of participants in the personalized trial arms who select this recommended intervention during follow-up relative to the total number of participants in Arms 1 & 2 will be presented as a count of participants/percentage, with a higher count of participants/percentage indicating greater levels of agreement.	Assessed after completion of follow-up (18 weeks from baseline).
Mean System Usability Score (SUS).	The SUS is a validated 10-item questionnaire that asks users to score each item on a Likert scale from Strongly Disagree (rating of 1) to Strongly Agree (rating of 5). The SUS has a minimum score of 0 and a maximum score of 40. The SUS will be presented to the participant as addressing the ease of use, complexity, consistency of the Personalized Trials system as a whole, from recruitment to receipt of the report. Odd items are scored by subtracting one from the user response. Even-numbered items are scored by subtracting the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Converted responses are summed and multiplied by 2.5. This converts the range of possible values to a composite measure from 0 to 100, reported below. Participant SUS scores will be averaged together and an overall mean will be reported with standard deviation. Higher scored values correlate to a more usable system, and therefore a better outcome.	Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
Participant Satisfaction With Personalized Trial Components.	Participants will rate their satisfaction with the Trial overall and with individual elements of the trial in a satisfaction survey. Satisfaction items are not part of an already existing scale but were developed to assess participant satisfaction with specific elements of the current study and the trial overall. Participants will rate their satisfaction on a scale of 1 to 5, with higher numbers indicating greater levels of satisfaction. Means and standard deviations will be reported for each element of satisfaction.	Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.	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 in each of the treatment periods (yoga, meditation, guided walking), and then averaged across each treatment period, to generate an overall mean and standard deviation for each period. Changes in EMA stress from baseline to each treatment period will be evaluated using Generalized Linear Mixed Model analyses.	EMA stress will be assessed 3 times daily via text message during the 18 week trial.
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue.	Fatigue 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 fatigue will be aggregated within the baseline assessment period and in each of the treatment periods (yoga, meditation, guided walking), and then averaged across each treatment period, to generate an overall mean and standard deviation for each period. Changes in EMA fatigue from baseline to each treatment period will be evaluated using Generalized Linear Mixed Model analyses.	EMA fatigue will be assessed 3 times daily via text message during the 18 week trial.
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain.	Pain 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 pain will be aggregated within the baseline assessment period and in each of the treatment periods (yoga, meditation, guided walking), and then averaged across each treatment period, to generate an overall mean and standard deviation for each period. Changes in EMA pain from baseline to each treatment period will be evaluated using Generalized Linear Mixed Model analyses.	EMA pain will be assessed 3 times daily via text message during the 18 week trial.
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood.	Mood 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 mood will be aggregated within the baseline assessment period and in each of the treatment periods (yoga, meditation, guided walking), and then averaged across each treatment period, to generate an overall mean and standard deviation for each period. Changes in EMA mood from baseline to each treatment period will be evaluated using Generalized Linear Mixed Model analyses.	EMA mood will be assessed 3 times daily via text message during the 18 week trial.
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration.	Concentration 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 Concentration will be aggregated within the baseline assessment period and in each of the treatment periods (yoga, meditation, guided walking), and then averaged across each treatment period, to generate an overall mean and standard deviation for each period. Changes in EMA Concentration from baseline to each treatment period will be evaluated using Generalized Linear Mixed Model analyses.	EMA concentration will be assessed 3 times daily via text message during the 18 week trial.
Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence.	Confidence 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 Confidence will be aggregated within the baseline assessment period and in each of the treatment periods (yoga, meditation, guided walking), and then averaged across each treatment period, to generate an overall mean and standard deviation for each period. Changes in EMA Confidence from baseline to each treatment period will be evaluated using Generalized Linear Mixed Model analyses.	EMA confidence will be assessed 3 times daily via text message during the 18 week trial.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within-Subject Difference in Fitbit Device-Recorded Daily Steps.	Daily step counts will be assessed by a Fitbit device. Daily step counts will be aggregated within the baseline assessment period and in each of the treatment periods (yoga, meditation, guided walking) to generate an overall mean and standard deviation for each period. Mean daily steps will be compared to baseline using three paired-samples t-tests (yoga vs baseline, meditation vs baseline, guided walking vs baseline). Daily steps values over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.	Daily steps will be assessed consistently via Fitbit device during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.
Within-Subject Difference in Fitbit Device-Recorded Nightly Sleep.	Nightly sleep duration will be assessed by a Fitbit device. Sleep duration will be aggregated within the baseline assessment period and in each of the treatment periods (yoga, meditation, guided walking) to generate an overall mean and standard deviation for each period. Mean sleep duration will be compared to baseline using three paired-samples t-tests (yoga vs baseline, meditation vs baseline, guided walking vs baseline). Sleep duration values over the course of the study will also be evaluated using Generalized Linear Mixed Model analyses.	Nightly sleep duration will be assessed consistently via Fitbit device during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.
Mean Participant Survey Adherence Rate.	For each participant of the proportion of surveys measures completed (both daily and weekly surveys) will be calculated. Completion rates across all participants will be reported with means and standard deviations.	Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
Mean Fitbit Device Adherence Rate.	For each participant, the proportion of days where the Fitbit device was worn will be calculated. Completion rates across all participants will be reported with means and standard deviations.	Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
Mean Participant Fitbit Sleep Rate.	For each participant, the average days of participant-observed sleep data, defined as recorded sleep and wake cycles, will be calculated across all participants with means and standard deviations.	Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
Mean Participant Personalized Trial Intervention Adherence Rate.	For each participant, the intervention adherence rate, defined as unique video views of the appropriate recorded intervention during the assigned interventions, will be calculated and reported across all applicable individuals with means and standard deviations.	Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
Mean Participant Standard Care Intervention Adherence Rate.	For each participant, the intervention adherence rate, defined as unique video views of the appropriate recorded intervention during the assigned interventions, will be calculated and reported across all applicable individuals with means and standard deviations.	Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
Mean Participant Selection Adherence Rate.	For each participant, the follow-up period adherence rate, defined as unique video views of the appropriate recorded intervention during the assigned follow-up period, will be calculated and reported across all individuals with means and standard deviations.	Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
Descriptive Content of Qualitative Interview Data	After completion of the trial, a random sample of 10% of participants from each arm will be asked to participate in 60-minute qualitative interviews to discuss their experiences. Descriptive content from these recorded and transcribed interviews will be analyzed and reported.	Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
Mean Participant Ecological Momentary Assessment (EMA) Adherence Rate.	For each participant of the proportion of EMA measures completed will be calculated. Completion rates across all participants will be reported with means and standard deviations.	Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Columbia University; National Library of Medicine (NLM)
• Investigators: Principal Investigator: Karina Davidson, PhD, MASc, Northwell Health

Publications and helpful links

General Publications

• Goodwin AM, Miller D, D'Angelo S, Perrin A, Wiener R, Greene B, Romain AN, Arader L, Chandereng T, Kuen Cheung Y, Davidson KW, Butler M. Protocol for randomized personalized trial for stress management compared to standard of care. Front Psychol. 2023 Sep 19;14:1233884. doi: 10.3389/fpsyg.2023.1233884. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): January 7, 2024
• Study Completion (Actual): January 8, 2024

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; Yoga; Stress; Mindfulness; Walking; Personalized; N-of-1; Virtual
• Other Study ID Numbers: 21-0968; R01LM012836 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.

Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) Time Frame: The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form following completion of recruitment but prior to publication of any data from the current study. De-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.

Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No