Personalized Trials for Stress Management Against Standard of Care

NCT05408832 | Completed Phase 2 Results DMC

• 2 other identifiers: 21-0968R01LM012836
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

Stress; Personalized; N-of-1; Virtual; Feasibility; Yoga; Walking; Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in Mean Within-Subject Difference in Weekly Perceived Stress.

  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.

  Assessed after completion of follow-up (18 weeks from baseline).

• Mean System Usability Score (SUS).

  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.

  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.

  EMA stress will be assessed 3 times daily via text message during the 18 week trial.

Other Outcomes (10)

• Within-Subject Difference in Fitbit Device-Recorded Daily Steps.

  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 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.

  Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).

Study Arms (3)

Personalized Trial ABCCBA

EXPERIMENTAL

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

Personalized Trial CBAABC

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

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)

Interventions

Personalized Trial ABCCBA BEHAVIORAL

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.

Personalized Trial ABCCBA

Personalized Trial CBAABC BEHAVIORAL

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.

Personalized Trial CBAABC

Stress Management Techniques with No Randomization Sequence (or order) BEHAVIORAL

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwell Health: lead
• National Library of Medicine (NLM): collaborator
• Columbia University: collaborator

Study Sites (1)

Institute of Health System Science

New York, New York, 10022, United States

Location

Related Publications (1)

• 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.

  PMID: 37794909 DERIVED

Results Point of Contact

• Title: Dr. Mark Butler, PhD
• Organization: Northwell Health

markbutler@northwell.edu

908-414-0238

Study Officials

• Karina Davidson, PhD, MASc

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed between and within (Crossover) participant assignment. The study uses a between participant randomization; two arms have a multiple crossover design (with different intervention orders to the crossover) and one arm has no order prescribed.

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 7, 2022
• Study Start: June 23, 2022
• Primary Completion: January 7, 2024
• Study Completion: January 8, 2024
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)