Personalized Trials for Stress Management Against Standard of Care

Stress Clinical Trial

Official title:

Re-engineering Precision Therapeutics Through N-of-1 Trials: Personalized Trials for Stress Management Against Standard of Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408832
• Other study ID #: 21-0968
• Secondary ID: R01LM012836
• Status: Completed
• Phase: Phase 2
• Start date: June 23, 2022
• Est. completion date: January 8, 2024

Study information

• Verified date: January 2024
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 8, 2024
• Est. primary completion date: January 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Institute of Health System Science	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Northwell Health	Columbia University, National Library of Medicine (NLM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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).
Other	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).
Other	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).
Other	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).
Other	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).
Other	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).
Other	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).
Other	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).
Primary	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	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).
Secondary	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 proportion, with a higher proportion indicating greater levels of agreement.	Assessed after completion of follow-up (18 weeks from baseline).
Secondary	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 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. Individual results are calculated to arrive at a composite measure out of 100. 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).
Secondary	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).
Secondary	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, in each of the treatment periods (yoga, meditation, guided walking), and during the follow-up period to generate an overall mean and standard deviation for each period. Changes in EMA stress over the course of the entire study will be evaluated using Generalized Linear Mixed Model analyses.	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.
Secondary	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 fatigue 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) to generate an overall mean and standard deviation for each period. Changes in EMA fatigue over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.	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.
Secondary	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 pain 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) to generate an overall mean and standard deviation for each period. Changes in EMA pain over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.	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.
Secondary	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 mood on a scale of 0 (poor) to 10 (excellent). Levels of EMA mood 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. Changes in EMA mood over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.	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.
Secondary	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 concentration 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) to generate an overall mean and standard deviation for each period. Changes in EMA concentration over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.	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.
Secondary	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 confidence 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) to generate an overall mean and standard deviation for each period. Changes in EMA confidence over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.	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.