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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 10/12/2022 | Other Identifier | UW Madison | |
| A483000 | Other Identifier | UW Madison | |
| 5K01MH117222 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Minds Program (HMP) | Experimental | Fully remote, 4-week meditation intervention |
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| Waitlist Control | No Intervention | Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth Meditation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, following week 4 of intervention period, and 3 month follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Grupe, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Healthy Minds | Madison | Wisconsin | 53703 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32424287 | Background | Heller AS, Shi TC, Ezie CEC, Reneau TR, Baez LM, Gibbons CJ, Hartley CA. Association between real-world experiential diversity and positive affect relates to hippocampal-striatal functional connectivity. Nat Neurosci. 2020 Jul;23(7):800-804. doi: 10.1038/s41593-020-0636-4. Epub 2020 May 18. |
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The investigators may share coded data with researchers to address future research questions not included in this application, with a complementary study being conducted at the Center for Healthy Minds which is utilizing many of the same survey and behavioral task measures, and/or with journals where open data sharing policies are encouraged or are a requirement for publication. Coded data may be shared as Supplemental Information uploaded to journal websites.
The investigators may share fully de-identified data from the study on data sharing platforms (e.g., OSF, NIMH Data Archive) for use by non-collaborators. Data shared on data sharing platforms will be uploaded via the internet. Confidentiality will be protected by stripping the data of all identifiers, including HIPAA identifiers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Minds Program (HMP) | Fully remote, 4-week meditation intervention mHealth 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. |
| FG001 | Waitlist Control | Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Minds Program (HMP) | Fully remote, 4-week meditation intervention |
| BG001 | Waitlist Control | Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up |
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Approximately 5 months (between enrollment and follow-up data completion)
Definitions do not differ from those on clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Minds Program (HMP) | Fully remote, 4-week meditation intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Grupe | University of Wisconsin-Madison | 608-263-7572 | grupe@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2023 | Sep 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 13, 2022 | Sep 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| Baseline, following week 4 of intervention period, and 3 month follow-up |
| 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). | Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up |
| 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). | Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up |
| 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). | Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up |
| 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. | Baseline, following week 4 of intervention period, and 3 month follow-up |
| 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. | Baseline, following week 4 of intervention period, and 3 month follow-up |
| 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. | Baseline and following week 4 of intervention period |
| 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) | Exploratory analyses will examine linear and nonlinear trajectories of change from baseline through 3-month follow-up |
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| BG002 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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. | The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint. | Posted | Mean | Standard Deviation | Lure Discrimination Index | Baseline, following week 4 of intervention period, and 3 month follow-up |
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| 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). | The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up |
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| 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). | The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up |
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| 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. | The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, following week 4 of intervention period, and 3 month follow-up |
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| 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). | The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up |
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| 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. | The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, following week 4 of intervention period, and 3 month follow-up |
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| 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. | The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, following week 4 of intervention period, and 3 month follow-up |
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| 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. | Not Posted | Baseline and following week 4 of intervention period | Participants |
| 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) | Not Posted | Exploratory analyses will examine linear and nonlinear trajectories of change from baseline through 3-month follow-up | Participants |
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| EG001 | Waitlist Control | Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study | 0 | 50 | 0 | 50 | 0 | 50 |
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