StressPhase 2NCT05408832
Personalized Trials for Stress Management Against Standard of Care
A Phase 2 study testing Personalized Trial ABCCBA, Personalized Trial CBAABC and Stress Management Techniques with No Randomization Sequence (or order) in people with Stress, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Personalized Trial ABCCBA, Personalized Trial CBAABC and Stress Management Techniques with No Randomization Sequence (or order)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 8 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Health System Science
New York, New York, 10022
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress
- Being tested
- Personalized Trial ABCCBA, Personalized Trial CBAABC, Stress Management Techniques with No Randomization Sequence (or order)
- Keywords
- Stress, Personalized, N-of-1, Virtual, Feasibility, Yoga, Walking, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Trial ABCCBABehavioural
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 CBAABCBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Behavioral: Stress Management Techniques with No Randomization Sequence (or order) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: EMA confidence will be assessed 3 times daily via text message during the 18 week trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start23 Jun 2022
- Primary completion7 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM), Columbia University
- Responsible party
- Sponsor
- Investigators
- Karina Davidson, PhD, MASc, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408832
- Sponsor's protocol ID
- 21-0968
- Other IDs
- R01LM012836
- Status last verified
- Mar 2026
- First submitted
- 2 Jun 2022
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 37794909
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-engineering Precision Therapeutics Through N-of-1 Trials: Personalized Trials for Stress Management Against Standard of Care
- ClinicalTrials.gov ID
- NCT05408832
- Acronym / sponsor ID
- 21-0968
- Conditions
- Stress
- Keywords
- Stress, Personalized, N-of-1, Virtual, Feasibility, Yoga, Walking, Mindfulness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM), Columbia University
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 7 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Personalized Trial ABCCBA | Experimental | Behavioral: Personalized Trial ABCCBAParticipants 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. |
| Personalized Trial CBAABC | Experimental | Behavioral: Personalized Trial CBAABCParticipants 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. |
| Standard Care | Active comparator | Behavioral: Stress Management Techniques with No Randomization Sequence (or order)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Trial ABCCBAParticipants 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. | Behavioural | Personalized Trial ABCCBA |
| Personalized Trial CBAABCParticipants 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. | Behavioural | Personalized Trial CBAABC |
| 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. | Behavioural | Standard Care |
Primary outcome
Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress.
Time frame: 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).
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.
10 secondary outcomes
Change in Mean Within-Subject Difference in Weekly Perceived Stress.
Time frame: 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.
Time frame: Assessed after completion of follow-up (18 weeks from baseline).
Mean System Usability Score (SUS).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: EMA confidence will be assessed 3 times daily via text message during the 18 week trial.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37794909Goodwin 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina Davidson, PhD, MASc principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Personalized Trial ABCCBA, Personalized Trial CBAABC and Stress Management Techniques with No Randomization Sequence (or order) in people with Stress, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-Arm Difference in Change in Ecological Momentary Assessment (EMA) of Stress. (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05408832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.