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Brain and Meditation (BAM) Study

Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05215314
Enrollment
150
Registered
2022-01-31
Start date
2022-04-13
Completion date
2024-01-09
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Stress

Keywords

healthy minds program, mobile health

Brief summary

This study is a randomized controlled trial to test the impact of an app-based meditation program on perceived stress and behavioral correlates of stress with known neurobiological correlates. Healthy adult participants between the ages of 25-65 will be enrolled in the study for about 4-5 months.

Detailed description

Participants will be randomized into one of two groups: the intervention group or the waitlist control group. The intervention group will use a mobile health app for four weeks. Participants will complete pre-intervention, weekly, post-intervention, and 3-month follow-up surveys and tasks. Primary Objective: Test for hypothesized group differences in perceived stress during participation in a 4-week meditation program and at 3-month follow-up. Secondary Objective: Within the meditation group, determine whether reductions in perceived stress are associated with changes in hippocampal-dependent behavior.

Interventions

BEHAVIORALmHealth Meditation

Participants will receive access to the 4-week Healthy Minds Program (HMP) Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Individual can read, write, speak, and understand English * Able to provide informed consent * Willing and able to complete all study procedures, including the Healthy Minds Program * Has access to a smartphone that can download apps from Google Play or the Apple App Store * US citizen or a permanent US resident (green card holder)

Exclusion criteria

* Extensive experience in meditation practice (e.g., regular daily meditation practice for the past 6 months or regular weekly meditation practice for the past 12 months), experience in substantively similar meditation training programs (e.g., attended a meditation retreat or a yoga/body practice retreat with a significant mediation component), or substantial previous use of the Healthy Minds Program app * Individuals will be excluded if they previously participated in substantively similar research at our Center at the discretion of the investigator due to similar tasks being used in certain studies * History of psychosis * History of mania * Current psychopathology that interferes with study participation

Design outcomes

Primary

MeasureTime frameDescription
Change in Perceived Stress Scale (PSS) ScoreBaseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-upPSS is a 10-item survey scored on a 5 point likert scale from 0 = never to 4 = very often, for a total possible range of scores from 0-40 where higher scores indicate higher perceived stress.

Secondary

MeasureTime frameDescription
Change in Behavioral Pattern Separation TaskBaseline, following week 4 of intervention period, and 3 month follow-upParticipants will complete a behavioral pattern separation task . During this task, participants will encode pictures of common objects while performing a basic categorization task. Participants will then label pictures as Old (targets, identical objects to those in the encoding phase), New (foils, or completely novel objects), or Similar (lure items, distinct exemplars of objects seen during encoding). The measure of interest on this task is the Lure Discrimination Index, which is calculated as the proportion of lures correctly identified as similar minus the proportion of foils that are incorrectly identified as similar. The theoretical range for the pattern separation index is \[-1,1\], with higher scores indicating better performance.
Change in PROMIS Depression ScoreBaseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-upThe PROMIS Depression Score is a measure of feelings of depression in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale from 1 (never) to 5 (always) with higher scores indicating increased depression. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of depression. A t score \>= 59.9 is indicative of moderate depression, a t score \>= 65.8 is indicative of moderately severe depression, and a t score \>= 71.5 is indicative of severe depression (based on corresponding cutoffs on the Patient Health Questionnaire-9).
Change in PROMIS Anxiety ScoreBaseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-upThe PROMIS Anxiety Score is a measure of feelings of anxiety in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale from 1 (never) to 5 (always) with higher scores indicating increased anxiety. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of anxiety. A t score \>= 62.3 is indicative of moderate anxiety and a t score \>= 67.7 is indicative of severe anxiety (based on corresponding cutoffs on the General Anxiety Disorder-7).

Other

MeasureTime frameDescription
Change in Healthy Minds Index (HMI) ScoreBaseline and following week 4 of intervention periodHMI is a 17-item survey scored on a 5 point likert scale from 0 (never, none, not at all) to 4 (always, every time, to the highest degree) that assesses awareness, connection, insight, and purpose. Higher scores indicate higher sense of awareness, connection, insight, and purpose. Mean score for each subscale will be reported.
Change in Posttraumatic Stress Disorder Checklist (PCL-5) ScoreBaseline, following week 4 of intervention period, and 3 month follow-upThe PCL-5 is a 20-item survey scored on a 5 point likert scale from 0 (not at all) to 4 (extremely) for a total possible range of score from 0-80 where higher scores indicate more symptoms of PTSD within the last 30 days.
Change in Roaming EntropyExploratory analyses will examine linear and nonlinear trajectories of change from baseline through 3-month follow-upRoaming entropy will be calculated according to the formula in Heller et al. (2020). Using continuous GPS location tracking, the measure takes into account distance traveled and distinct locations visited, with a single resulting value reflecting the diversity of movement through one's lived environment (Measured continuously throughout study participation)
Change in PROMIS Sleep Disturbance ScoreBaseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-upThe PROMIS Sleep Disturbance Score is a measure of sleep in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale with higher scores indicating increased sleep disturbance. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of sleep disturbances. A t score \>= 45.1 is indicative of significant sleep disturbances (based on a corresponding cutoff of \>= 5 on the Pittsburgh Sleep Quality Index).
Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) ScoreBaseline, following week 4 of intervention period, and 3 month follow-upThe FFMQ-A8 is an 8-item survey scored on a 5 point likert scale from 'never, or very rarely true' to 'very often or always true', for a total possible range of scores from 8-40 where higher scores indicate greater mindfulness awareness.
Change in NIH Toolbox Loneliness ScoreBaseline, following week 4 of intervention period, and 3 month follow-upNIH toolbox Loneliness is a 5-item survey scored on a 5 point likert scale. The average score is taken across items for a total possible range of scores from 1-5, where higher scores indicate increased loneliness.

Countries

United States

Participant flow

Participants by arm

ArmCount
Healthy Minds Program (HMP)
Fully remote, 4-week meditation intervention
100
Waitlist Control
Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
50
Total150

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up22
Overall StudyPhysician Decision10
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicHealthy Minds Program (HMP)Waitlist ControlTotal
Age, Continuous39.9 years
STANDARD_DEVIATION 10
40.6 years
STANDARD_DEVIATION 11
40.2 years
STANDARD_DEVIATION 10.3
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants8 Participants21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
86 Participants42 Participants128 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
8 Participants5 Participants13 Participants
Race (NIH/OMB)
Black or African American
12 Participants10 Participants22 Participants
Race (NIH/OMB)
More than one race
8 Participants6 Participants14 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants2 Participants4 Participants
Race (NIH/OMB)
White
70 Participants27 Participants97 Participants
Region of Enrollment
United States
100 participants50 participants150 participants
Sex: Female, Male
Female
50 Participants25 Participants75 Participants
Sex: Female, Male
Male
50 Participants25 Participants75 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 990 / 50
other
Total, other adverse events
0 / 990 / 50
serious
Total, serious adverse events
0 / 990 / 50

Outcome results

Primary

Change in Perceived Stress Scale (PSS) Score

PSS is a 10-item survey scored on a 5 point likert scale from 0 = never to 4 = very often, for a total possible range of scores from 0-40 where higher scores indicate higher perceived stress.

Time frame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Minds Program (HMP)Change in Perceived Stress Scale (PSS) Scorebaseline15.0 score on a scaleStandard Deviation 6.49
Healthy Minds Program (HMP)Change in Perceived Stress Scale (PSS) Scoreweek 113.5 score on a scaleStandard Deviation 6.71
Healthy Minds Program (HMP)Change in Perceived Stress Scale (PSS) Scoreweek 213.1 score on a scaleStandard Deviation 7.03
Healthy Minds Program (HMP)Change in Perceived Stress Scale (PSS) Scoreweek 312.5 score on a scaleStandard Deviation 6.43
Healthy Minds Program (HMP)Change in Perceived Stress Scale (PSS) Scoreweek 413.6 score on a scaleStandard Deviation 6.6
Healthy Minds Program (HMP)Change in Perceived Stress Scale (PSS) Score3 month follow up13.8 score on a scaleStandard Deviation 6.96
Waitlist ControlChange in Perceived Stress Scale (PSS) Scoreweek 416.7 score on a scaleStandard Deviation 6.91
Waitlist ControlChange in Perceived Stress Scale (PSS) Scorebaseline17.1 score on a scaleStandard Deviation 7.42
Waitlist ControlChange in Perceived Stress Scale (PSS) Scoreweek 315.6 score on a scaleStandard Deviation 6.52
Waitlist ControlChange in Perceived Stress Scale (PSS) Scoreweek 117.1 score on a scaleStandard Deviation 7.48
Waitlist ControlChange in Perceived Stress Scale (PSS) Score3 month follow up17.8 score on a scaleStandard Deviation 6.76
Waitlist ControlChange in Perceived Stress Scale (PSS) Scoreweek 215.1 score on a scaleStandard Deviation 7.94
Secondary

Change in Behavioral Pattern Separation Task

Participants will complete a behavioral pattern separation task . During this task, participants will encode pictures of common objects while performing a basic categorization task. Participants will then label pictures as Old (targets, identical objects to those in the encoding phase), New (foils, or completely novel objects), or Similar (lure items, distinct exemplars of objects seen during encoding). The measure of interest on this task is the Lure Discrimination Index, which is calculated as the proportion of lures correctly identified as similar minus the proportion of foils that are incorrectly identified as similar. The theoretical range for the pattern separation index is \[-1,1\], with higher scores indicating better performance.

Time frame: Baseline, following week 4 of intervention period, and 3 month follow-up

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Minds Program (HMP)Change in Behavioral Pattern Separation Taskbaseline.507 Lure Discrimination IndexStandard Deviation 0.201
Healthy Minds Program (HMP)Change in Behavioral Pattern Separation Taskweek 4.502 Lure Discrimination IndexStandard Deviation 0.212
Healthy Minds Program (HMP)Change in Behavioral Pattern Separation Task3 month follow up.542 Lure Discrimination IndexStandard Deviation 0.169
Waitlist ControlChange in Behavioral Pattern Separation Taskbaseline.456 Lure Discrimination IndexStandard Deviation 0.197
Waitlist ControlChange in Behavioral Pattern Separation Taskweek 4.489 Lure Discrimination IndexStandard Deviation 0.179
Waitlist ControlChange in Behavioral Pattern Separation Task3 month follow up.483 Lure Discrimination IndexStandard Deviation 0.205
Secondary

Change in PROMIS Anxiety Score

The PROMIS Anxiety Score is a measure of feelings of anxiety in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale from 1 (never) to 5 (always) with higher scores indicating increased anxiety. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of anxiety. A t score \>= 62.3 is indicative of moderate anxiety and a t score \>= 67.7 is indicative of severe anxiety (based on corresponding cutoffs on the General Anxiety Disorder-7).

Time frame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Minds Program (HMP)Change in PROMIS Anxiety Scorebaseline55.8 score on a scaleStandard Deviation 7.36
Healthy Minds Program (HMP)Change in PROMIS Anxiety Scoreweek 155.3 score on a scaleStandard Deviation 7.56
Healthy Minds Program (HMP)Change in PROMIS Anxiety Scoreweek 254.9 score on a scaleStandard Deviation 8.05
Healthy Minds Program (HMP)Change in PROMIS Anxiety Scoreweek 354.0 score on a scaleStandard Deviation 7.95
Healthy Minds Program (HMP)Change in PROMIS Anxiety Scoreweek 453.1 score on a scaleStandard Deviation 8.3
Healthy Minds Program (HMP)Change in PROMIS Anxiety Score3 month follow up54.3 score on a scaleStandard Deviation 8.06
Waitlist ControlChange in PROMIS Anxiety Scoreweek 456.2 score on a scaleStandard Deviation 8.72
Waitlist ControlChange in PROMIS Anxiety Scorebaseline58.0 score on a scaleStandard Deviation 8.46
Waitlist ControlChange in PROMIS Anxiety Scoreweek 357.4 score on a scaleStandard Deviation 7.9
Waitlist ControlChange in PROMIS Anxiety Scoreweek 157.4 score on a scaleStandard Deviation 8.31
Waitlist ControlChange in PROMIS Anxiety Score3 month follow up57.5 score on a scaleStandard Deviation 6.94
Waitlist ControlChange in PROMIS Anxiety Scoreweek 255.8 score on a scaleStandard Deviation 7.7
Secondary

Change in PROMIS Depression Score

The PROMIS Depression Score is a measure of feelings of depression in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale from 1 (never) to 5 (always) with higher scores indicating increased depression. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of depression. A t score \>= 59.9 is indicative of moderate depression, a t score \>= 65.8 is indicative of moderately severe depression, and a t score \>= 71.5 is indicative of severe depression (based on corresponding cutoffs on the Patient Health Questionnaire-9).

Time frame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Minds Program (HMP)Change in PROMIS Depression Scorebaseline52.4 score on a scaleStandard Deviation 7.16
Healthy Minds Program (HMP)Change in PROMIS Depression Scoreweek 151.6 score on a scaleStandard Deviation 8.17
Healthy Minds Program (HMP)Change in PROMIS Depression Scoreweek 251.3 score on a scaleStandard Deviation 8.08
Healthy Minds Program (HMP)Change in PROMIS Depression Scoreweek 351.1 score on a scaleStandard Deviation 8.27
Healthy Minds Program (HMP)Change in PROMIS Depression Scoreweek 450.2 score on a scaleStandard Deviation 7.97
Healthy Minds Program (HMP)Change in PROMIS Depression Score3 month follow up51.9 score on a scaleStandard Deviation 8.44
Waitlist ControlChange in PROMIS Depression Scoreweek 452.8 score on a scaleStandard Deviation 8.25
Waitlist ControlChange in PROMIS Depression Scorebaseline54.7 score on a scaleStandard Deviation 7.28
Waitlist ControlChange in PROMIS Depression Scoreweek 355.0 score on a scaleStandard Deviation 8.35
Waitlist ControlChange in PROMIS Depression Scoreweek 154.8 score on a scaleStandard Deviation 7.42
Waitlist ControlChange in PROMIS Depression Score3 month follow up54.4 score on a scaleStandard Deviation 7.91
Waitlist ControlChange in PROMIS Depression Scoreweek 242.3 score on a scaleStandard Deviation 9.28
Other Pre-specified

Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score

The FFMQ-A8 is an 8-item survey scored on a 5 point likert scale from 'never, or very rarely true' to 'very often or always true', for a total possible range of scores from 8-40 where higher scores indicate greater mindfulness awareness.

Time frame: Baseline, following week 4 of intervention period, and 3 month follow-up

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Minds Program (HMP)Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) ScoreBaseline27.9 score on a scaleStandard Deviation 6.88
Healthy Minds Program (HMP)Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Scoreweek 428.3 score on a scaleStandard Deviation 6.02
Healthy Minds Program (HMP)Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score3-month follow-up29.1 score on a scaleStandard Deviation 6.41
Waitlist ControlChange in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) ScoreBaseline27.8 score on a scaleStandard Deviation 7.36
Waitlist ControlChange in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Scoreweek 428.3 score on a scaleStandard Deviation 7.41
Waitlist ControlChange in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score3-month follow-up28.0 score on a scaleStandard Deviation 7.41
Other Pre-specified

Change in Healthy Minds Index (HMI) Score

HMI is a 17-item survey scored on a 5 point likert scale from 0 (never, none, not at all) to 4 (always, every time, to the highest degree) that assesses awareness, connection, insight, and purpose. Higher scores indicate higher sense of awareness, connection, insight, and purpose. Mean score for each subscale will be reported.

Time frame: Baseline and following week 4 of intervention period

Other Pre-specified

Change in NIH Toolbox Loneliness Score

NIH toolbox Loneliness is a 5-item survey scored on a 5 point likert scale. The average score is taken across items for a total possible range of scores from 1-5, where higher scores indicate increased loneliness.

Time frame: Baseline, following week 4 of intervention period, and 3 month follow-up

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Minds Program (HMP)Change in NIH Toolbox Loneliness Score3-month follow-up2.25 score on a scaleStandard Deviation 1.07
Healthy Minds Program (HMP)Change in NIH Toolbox Loneliness ScoreBaseline2.44 score on a scaleStandard Deviation 1.02
Healthy Minds Program (HMP)Change in NIH Toolbox Loneliness Scoreweek 42.17 score on a scaleStandard Deviation 1
Waitlist ControlChange in NIH Toolbox Loneliness ScoreBaseline2.28 score on a scaleStandard Deviation 0.84
Waitlist ControlChange in NIH Toolbox Loneliness Scoreweek 42.19 score on a scaleStandard Deviation 0.9
Waitlist ControlChange in NIH Toolbox Loneliness Score3-month follow-up2.25 score on a scaleStandard Deviation 0.95
Other Pre-specified

Change in Posttraumatic Stress Disorder Checklist (PCL-5) Score

The PCL-5 is a 20-item survey scored on a 5 point likert scale from 0 (not at all) to 4 (extremely) for a total possible range of score from 0-80 where higher scores indicate more symptoms of PTSD within the last 30 days.

Time frame: Baseline, following week 4 of intervention period, and 3 month follow-up

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Minds Program (HMP)Change in Posttraumatic Stress Disorder Checklist (PCL-5) ScoreBaseline15.6 score on a scaleStandard Deviation 12.2
Healthy Minds Program (HMP)Change in Posttraumatic Stress Disorder Checklist (PCL-5) Scoreweek 413.2 score on a scaleStandard Deviation 12.1
Healthy Minds Program (HMP)Change in Posttraumatic Stress Disorder Checklist (PCL-5) Score3-month follow-up13.9 score on a scaleStandard Deviation 12.6
Waitlist ControlChange in Posttraumatic Stress Disorder Checklist (PCL-5) ScoreBaseline17.2 score on a scaleStandard Deviation 13
Waitlist ControlChange in Posttraumatic Stress Disorder Checklist (PCL-5) Scoreweek 417.8 score on a scaleStandard Deviation 16.1
Waitlist ControlChange in Posttraumatic Stress Disorder Checklist (PCL-5) Score3-month follow-up20.1 score on a scaleStandard Deviation 13.4
Other Pre-specified

Change in PROMIS Sleep Disturbance Score

The PROMIS Sleep Disturbance Score is a measure of sleep in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale with higher scores indicating increased sleep disturbance. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of sleep disturbances. A t score \>= 45.1 is indicative of significant sleep disturbances (based on a corresponding cutoff of \>= 5 on the Pittsburgh Sleep Quality Index).

Time frame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Minds Program (HMP)Change in PROMIS Sleep Disturbance ScoreBaseline52.0 score on a scaleStandard Deviation 8.12
Healthy Minds Program (HMP)Change in PROMIS Sleep Disturbance Scoreweek 151.3 score on a scaleStandard Deviation 9.05
Healthy Minds Program (HMP)Change in PROMIS Sleep Disturbance Scoreweek 250.6 score on a scaleStandard Deviation 8.27
Healthy Minds Program (HMP)Change in PROMIS Sleep Disturbance Scoreweek 349.8 score on a scaleStandard Deviation 9.33
Healthy Minds Program (HMP)Change in PROMIS Sleep Disturbance Scoreweek 450.1 score on a scaleStandard Deviation 9.1
Healthy Minds Program (HMP)Change in PROMIS Sleep Disturbance Score3-month follow-up50.5 score on a scaleStandard Deviation 8.6
Waitlist ControlChange in PROMIS Sleep Disturbance Scoreweek 453.3 score on a scaleStandard Deviation 9.95
Waitlist ControlChange in PROMIS Sleep Disturbance ScoreBaseline54.4 score on a scaleStandard Deviation 9.28
Waitlist ControlChange in PROMIS Sleep Disturbance Scoreweek 353.6 score on a scaleStandard Deviation 8.92
Waitlist ControlChange in PROMIS Sleep Disturbance Scoreweek 154.0 score on a scaleStandard Deviation 9.24
Waitlist ControlChange in PROMIS Sleep Disturbance Score3-month follow-up55.1 score on a scaleStandard Deviation 9.84
Waitlist ControlChange in PROMIS Sleep Disturbance Scoreweek 252.9 score on a scaleStandard Deviation 9.66
Other Pre-specified

Change in Roaming Entropy

Roaming entropy will be calculated according to the formula in Heller et al. (2020). Using continuous GPS location tracking, the measure takes into account distance traveled and distinct locations visited, with a single resulting value reflecting the diversity of movement through one's lived environment (Measured continuously throughout study participation)

Time frame: Exploratory analyses will examine linear and nonlinear trajectories of change from baseline through 3-month follow-up

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026