Clinical trial NCT05408832: Personalized Trials for Stress Management Against Standard of Care
Official title: Re-engineering Precision Therapeutics Through N-of-1 Trials: Personalized Trials for Stress Management Against Standard of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress
Keywords: Stress
Personalized
N-of-1
Virtual
Feasibility
Yoga
Walking
Mindfulness
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
name: Columbia University
First posted: 2022-06-07
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress.
timeFrame: : 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:
measure: Change in Mean Within-Subject Difference in Weekly Perceived Stress.
timeFrame: Perceived stress will be assessed weekly during the baseline assessment period (2 weeks) during follow-up period (13-18 weeks).
measure: Agreement of Intervention Selection Between Participant and Researcher.
timeFrame: Assessed after completion of follow-up (18 weeks from baseline).
measure: Mean System Usability Score (SUS).
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
measure: Participant Satisfaction with Personalized Trial Components.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.
timeFrame: EMA fatigue will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue.
timeFrame: EMA fatigue will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain.
timeFrame: EMA pain will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood.
timeFrame: EMA mood will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration.
timeFrame: EMA concentration will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence.
timeFrame: EMA fatigue will be assessed 3 times daily via text message during the baseline assessment period (2 weeks), during intervention period (12 weeks) and during follow-up period (4 weeks), 18 weeks total.
Other outcomes:
measure: Within-Subject Difference in Fitbit Device-Recorded Daily Steps.
timeFrame: 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.
measure: Within-Subject Difference in Fitbit Device-Recorded Nightly Sleep.
timeFrame: 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.
measure: Mean Participant Survey Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
measure: Mean Participant Ecological Momentary Assessment (EMA) adherence rate.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
measure: Mean Fitbit Device Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
measure: Mean Participant Fitbit Sleep Rate.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
measure: Mean Participant Personalized Trial Intervention Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
measure: Mean Participant Standard Care Intervention Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
measure: Mean Participant Selection Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
measure: Descriptive Content of Qualitative Interview Data
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (18 weeks from baseline).
Locations:
city: New York
country: United States
facility: Institute of Health System Science
state: New York
Study officials:
affiliation: Northwell Health
name: Karina Davidson, PhD, MASc
role: PRINCIPAL_INVESTIGATOR
References: