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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 6/29/2023 | Other Identifier | UW Madison | |
| A487400 | Other Identifier | UW Madison | |
| 1U24AT011289-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Hope for Depression Research Foundation | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The central aim of this study is to test the efficacy of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 1100 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation [HMP without meditation practice]), and a waitlist control in a sample of United States adults with elevated depression symptoms.
Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of meditation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. This project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. Furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Minds Program (HMP) app | Experimental | Participants will receive access to the 4-week 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. |
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| Psychoeducation app | Active Comparator | Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices. |
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| Usual Care | No Intervention | Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Minds Program | Device | HMP is a 4-week mobile health (mHealth) meditation training program. |
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| Measure | Description | Time Frame |
|---|---|---|
| Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | The GAD-7 is a 7-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Biomarkers: C-reactive Protein (CRP) | Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from ~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1). |
Inclusion Criteria:
Exclusion Criteria:
Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- Previous use of Healthy Minds Program app
Current suicidal intent and/or high self-injury risk (determined from the interview)
Self-reported history of psychosis
Self-reported history of mania
Current psychopathology that interferes with study participation as assessed by interview
Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion)
Alcohol Use Disorders Identification Test (AUDIT) score ≥ 13 for women and AUDIT score ≥ 15 for men
Drug Use Disorders Identification Test (DUDIT) score ≥ 8 for women and men
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| Name | Affiliation | Role |
|---|---|---|
| Simon Goldberg, PhD | UW-Madison, Center for Healthy Minds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53703 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Minds Program (HMP) App | Participants will receive access to the 4-week 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. Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. |
| FG001 | Psychoeducation App | Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices. Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. |
| FG002 | Usual Care | Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Minds Program (HMP) App | Participants will receive access to the 4-week 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. Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. |
| Units | Counts |
|---|---|
| Participants |
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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 | Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score | The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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data collected up to 4 months on study
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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) App | Participants will receive access to the 4-week 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. Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Symptoms of Depression | Psychiatric disorders | Non-systematic Assessment | Increase in scores PHQ-8 scores indicate increase is depression symptoms. This is the number of participants with increases of 5 points or more. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simon Goldberg | Center for Healthy Minds | (608) 265-8986 | sbgoldberg@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 | Jan 16, 2025 | Apr 8, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 20, 2023 | Jul 22, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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The groups will be randomized to one of three groups in a 2:2:1 ratio.
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| Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | The PROMIS Sleep Disturbance scale is a computer-adaptive measure where participants report how often in the past 7 days they had various sleep-related experiences (e.g., "my sleep was restful"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, standard deviation (SD) = 10) where higher scores indicate more sleep disturbance. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Flourishing Measured by the Flourishing Index Score | The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Connection Measured by NIH Toolbox Loneliness Score | The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life's meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Pain Intensity Measured by PROMIS Pain Intensity Score | The single-item PROMIS Pain Intensity scale is a 1-item scale where participants report on their pain intensity in the past 7 days. It is scored on an 11-point Likert-scale where 0 = no pain and 10 = worst pain imaginable. Scores range from 0 to 10, with higher scores indicating higher pain intensity | Baseline, week 4 (of intervention period), and 3 month follow-up |
| Pain Interference Measured by PROMIS Pain Inference Scale Score | The PROMIS Pain Interference scale is a computer-adaptive measure where participants report how often in the past 7 days they had pain-related interference in their life (e.g., "how much did pain interfere with your enjoyment of life"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more pain interference. | Baseline, week 4 (of intervention period), and 3 month follow-up |
| Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | The Five Facet Mindfulness Questionnaire Nonjudgment Subscale is a 8-item subscale where participants report on their nonjudgment of experience in daily life. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater nonjudgment of experience. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Climate Change Anxiety Scale | The Climate Change Anxiety Scale is a 13-item scale where participants report their anxiety regarding climate change (e.g., "I have nightmares about climate change"). It is scored on a 5-point Likert scale where 1 = "never" to 5 = "almost always." Total scores range from 13 to 65 where higher scores indicate greater climate change anxiety. | Baseline, week 4, and 3 month follow up |
| Wellbeing Growth Mindset | The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., "Your well-being is something about you that you can't change very much."). It is scored on a 6-point Likert scale where 1 = "strongly disagree" to 6 = "strongly agree." Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset. | Baseline, week 4, and 3 month follow up |
| Healthy Minds Index (HM Index) - Awareness | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Awareness subscale is 0 to 16 where higher scores indicate more awareness. | Baseline, week 4, and 3 month follow up |
| Healthy Minds Index (HM Index) - Connection | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Connection subscale range from 0 to 24, where higher scores indicate more connection. | Baseline, week 4, and 3 month follow up |
| Healthy Minds Index (HM Index) - Insight | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Insight subscale range from 0 to 12, where higher scores indicate more insight. | Baseline, week 4, and 3 month follow up |
| Healthy Minds Index (HM Index) - Purpose | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Purpose subscale range from 0 to 16, where higher scores indicate more purpose. | Baseline, week 4, and 3 month follow up |
| Life Orientation Test - Revised | The Life Orientation Test - Revised is a 6-item scale where participants report their level of optimism (e.g., "In uncertain times, I usually expect the best"). It is scored on a 5-point Likert scale where 0 = "strongly disagree" to 4 = "strongly agree." Total scores range from 0 to 24 where higher scores indicate greater optimism. | Baseline, week 4, and 3 month follow up |
| Perceived Stress Scale | The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., "In the last month, how often have you felt nervous and 'stressed'?"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "very often." Total scores range from 0 to 40 where higher scores indicate greater perceived stress. | Baseline, week 4, and 3 month follow up |
| Perseverative Thinking Questionnaire | The Perseverative Thinking Questionnaire is a 15-item scale where participants report their level of repetitive negative thinking (e.g., "My thoughts repeat themselves"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "almost always." Total scores range from 0 to 60 where higher scores indicate greater perseverative thinking. | Baseline, week 4, and 3 month follow up |
| Satisfaction With Life Scale | The Satisfaction with Life Scale is a 5-item scale where participants report their level of satisfaction with life (e.g., "In most ways my life is close to ideal"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 5 to 35 where higher scores indicate greater satisfaction with life. | Baseline, week 4, and 3 month follow up |
| Subjective Happiness Scale | The Subjective Happiness Scale is a 4-item scale where participants report their level of subjective happiness (e.g., "In general, I consider myself [not a very happy person, a very happy person]"). It is scored on a 7-point Likert scale where 1 = less happy to 7 = more happy. Total scores range from 4 to 28 where higher scores indicate greater subjective happiness. | Baseline, week 4, and 3 month follow up |
| Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | The PRIUSS-3 is a 3-item scale where participants report their level of problematic internet use. It is scored on a 4-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 12, where higher scores indicate more problematic internet use. | Baseline, week 4, and 3 month follow up |
| Baseline and 3 month follow-up |
| Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from ~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1). | Baseline and 3 month follow-up |
| Microbiome Alpha Diversity: Species Richness | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Reported here are the observed (total number of distinct taxa) and calculated (Chao1 = N + S2 / (2 D), where N is the number of observed OTUs (Operational Taxonomic Units), S is the number of singleton OTUs, and D is the number of doublet OTUs) number of species represented in the sample. Chao1 is a species richness calculator that accounts for rare species. | Baseline and 3 month follow-up |
| Microbiome Alpha Diversity: Shannon Diversity Index (H') | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Shannon Diversity Index quantifies both the richness and the evenness of a community. It takes into account the number of taxa (richness) and their relative abundances (evenness). A higher Shannon index value indicates greater diversity, with both a high number of taxa and more even distribution of abundances among them. It is often used to assess the balance between species in a community. Typically ranges from 0-5 with higher numbers indicating increasing species diversity. | Baseline and 3 month follow-up |
| Microbiome Alpha Diversity: Inverse Simpson (1/D) | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson is the probability that any two microbes are the same species, ranging from 0-1. Inverse Simpson (1 / Simpson) considers both richness and evenness. It places greater weight on the more abundant taxa. A higher inverse Simpson index suggests a more even distribution of taxa, with fewer dominant species. The inverse Simpson index is sensitive to the presence of dominant species and may emphasize diversity loss when one or a few species dominate the community. | Baseline and 3 month follow-up |
| Microbiome Alpha Diversity: Pielou Evenness Index (J) | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Pielou Evenness Index measures how evenly the individuals are distributed across the taxa in a sample. It is calculated by dividing the Shannon diversity index by the maximum possible value of the Shannon index (which occurs when all taxa are equally abundant). The Pielou index ranges from 0 (no evenness, where one species dominates) to 1 (perfect evenness, where all species are equally abundant). | Baseline and 3 month follow-up |
| Microbiome Alpha Diversity: Simpson's Dominance Index (D) | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson's Dominance Index measures the probability that two randomly selected individuals from a community belong to the same species (or taxon). It ranges from 0 to 1, where 0 indicates perfect diversity (no dominance of a single species) and values closer to 1 indicate that one or a few species dominate the community. A lower Simpson's dominance score suggests a more diverse community, while a higher score indicates a community dominated by a few taxa. | Baseline and 3 month follow-up |
| Facial Behavior: Cheek Raise Score | Participants provide video recordings of their face while responding to a prompt watching brief videos of positive valence (e.g., baby giggling). Data are reported in Action Unit 6 (AU6) of Facial Action Coding System (FACS). FACS is an anatomically-based system for describing facial movement, breaking facial expressions into individual muscle movements called Action Units (AUs). The scores indicate the intensity of cheek movement (0-100), higher movements indicate more intense movement. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Lure Discrimination Task (LDI) | Meditation training has the capacity to normalize the overgeneralized inflexible cognition endemic to depression, which is hypothesized to relate to alterations in the hippocampal-dependent process of pattern separation. The investigators will use a pattern separation task to evaluate hippocampal function. The Lure Discrimination Task (LDI) is the difference between the probability of giving a "Similar" response to the lure items (similar to target items) minus the probability of giving a "Similar" response to the foils (unrelated to target items). Larger differences indicate increased discrimination. | Baseline, week 4 (of intervention period), and 3 month follow-up |
| Self-Referential Pronoun Use | Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore indicators of self-referent, inflexible, & over-generalized thinking within natural language. Reported here is the "I" self-referential word frequency. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Negative Affect Word Use: Negative Sentiment | Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate more intense negative sentiment. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Negative Affect Word Use: Positive Sentiment | Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate greater positive sentiment. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
| Treatment Expectancies | The Treatment Expectancies is a 6-item scale assessing how much participants believed the training program was helpful to them. Items assess how participants think (e.g., "At this point, how logical does the program offered to you seem?") and feel (e.g., "At this point, how much do you really feel that the program helped you to reduce your stress symptoms?"). Items are scored on either a 9-point Likert scale (e.g., 1 = "not at all logical" to 9 = "very logical") or on a percentage ("At the end of the program, how much improvement in your symptoms do you really feel occurred?", 0% to 100%). Higher scores reflect higher treatment expectancies. | 3-month follow-up |
| Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. Increase in scores indicates increase is depression symptoms. | Week 1, Week 2, Week 3, Week 4, 3-month follow-up |
| Digital Working Alliance Inventory | The Digital Working Alliance Inventory is a 6-item scale where participants report their working alliance with the HMP app (e.g., "The HMP app supports me to overcome challenges"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 6 to 42 where higher scores indicate greater working alliance. | week 1, week 2, week 3, week 4, and 3-month follow-up |
| Inclusion of Nature in Self | The Inclusion of Nature in Self is a single item measure assessing the degree to which someone views nature as a part of their sense of self. Participants indicate which of a series of overlapping circles most closely resembles nature and their self. More overlapping circles indicate greater inclusion of nature in self. | Baseline, week 4 (of intervention period), and 3 month follow-up |
| Mindfulness Adherence Questionnaire | The Mindfulness Adherence Questionnaire informal practice items are 6-items assessing the application of mindfulness during daily life (e.g., "In your daily life, how much of the time were you practicing being gentle and compassionate toward yourself?"). It is scored on a 7-point Likert scale where 0 = "never" to 6 = "always." Total scores range from 0 to 42 where higher scores indicate greater informal mindfulness practice. | week 1, week 2, week 3, week 4, and 3 month follow up |
| Change in Pre- and Post-practice Positive Affect | Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys. | Before and after HMP activities week 1, week 2, week 2, and week 4 |
| Change in Pre- and Post-practice Negative Affect | Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys. | Before and after HMP activities week 1, week 2, week 2, and week 4 |
| Change in Post-practice Focus | A single item assessing focus during HMP activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time. Data comes from multiple surveys. | Before and after HMP activities week 1, week 2, week 2, and week 4 |
| BG001 | Psychoeducation App | Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices. Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. |
| BG002 | Usual Care | Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Psychoeducation App | Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices. Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. |
| OG002 | Usual Care | Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. |
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| Secondary | Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score | The GAD-7 is a 7-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Secondary | Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | The PROMIS Sleep Disturbance scale is a computer-adaptive measure where participants report how often in the past 7 days they had various sleep-related experiences (e.g., "my sleep was restful"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, standard deviation (SD) = 10) where higher scores indicate more sleep disturbance. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | T-score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Secondary | Flourishing Measured by the Flourishing Index Score | The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing. | Some participants did not provide data at all time-points | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Secondary | Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score | The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Secondary | Connection Measured by NIH Toolbox Loneliness Score | The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Secondary | Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score | The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Secondary | Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score | The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life's meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | T-score | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Secondary | Pain Intensity Measured by PROMIS Pain Intensity Score | The single-item PROMIS Pain Intensity scale is a 1-item scale where participants report on their pain intensity in the past 7 days. It is scored on an 11-point Likert-scale where 0 = no pain and 10 = worst pain imaginable. Scores range from 0 to 10, with higher scores indicating higher pain intensity | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4 (of intervention period), and 3 month follow-up |
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| Secondary | Pain Interference Measured by PROMIS Pain Inference Scale Score | The PROMIS Pain Interference scale is a computer-adaptive measure where participants report how often in the past 7 days they had pain-related interference in their life (e.g., "how much did pain interfere with your enjoyment of life"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more pain interference. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | T-score | Baseline, week 4 (of intervention period), and 3 month follow-up |
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| Secondary | Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score | The Five Facet Mindfulness Questionnaire Nonjudgment Subscale is a 8-item subscale where participants report on their nonjudgment of experience in daily life. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater nonjudgment of experience. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Secondary | Climate Change Anxiety Scale | The Climate Change Anxiety Scale is a 13-item scale where participants report their anxiety regarding climate change (e.g., "I have nightmares about climate change"). It is scored on a 5-point Likert scale where 1 = "never" to 5 = "almost always." Total scores range from 13 to 65 where higher scores indicate greater climate change anxiety. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Wellbeing Growth Mindset | The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., "Your well-being is something about you that you can't change very much."). It is scored on a 6-point Likert scale where 1 = "strongly disagree" to 6 = "strongly agree." Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Healthy Minds Index (HM Index) - Awareness | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Awareness subscale is 0 to 16 where higher scores indicate more awareness. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Healthy Minds Index (HM Index) - Connection | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Connection subscale range from 0 to 24, where higher scores indicate more connection. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Healthy Minds Index (HM Index) - Insight | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Insight subscale range from 0 to 12, where higher scores indicate more insight. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Healthy Minds Index (HM Index) - Purpose | The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Purpose subscale range from 0 to 16, where higher scores indicate more purpose. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Life Orientation Test - Revised | The Life Orientation Test - Revised is a 6-item scale where participants report their level of optimism (e.g., "In uncertain times, I usually expect the best"). It is scored on a 5-point Likert scale where 0 = "strongly disagree" to 4 = "strongly agree." Total scores range from 0 to 24 where higher scores indicate greater optimism. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Perceived Stress Scale | The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., "In the last month, how often have you felt nervous and 'stressed'?"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "very often." Total scores range from 0 to 40 where higher scores indicate greater perceived stress. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Perseverative Thinking Questionnaire | The Perseverative Thinking Questionnaire is a 15-item scale where participants report their level of repetitive negative thinking (e.g., "My thoughts repeat themselves"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "almost always." Total scores range from 0 to 60 where higher scores indicate greater perseverative thinking. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Satisfaction With Life Scale | The Satisfaction with Life Scale is a 5-item scale where participants report their level of satisfaction with life (e.g., "In most ways my life is close to ideal"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 5 to 35 where higher scores indicate greater satisfaction with life. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Subjective Happiness Scale | The Subjective Happiness Scale is a 4-item scale where participants report their level of subjective happiness (e.g., "In general, I consider myself [not a very happy person, a very happy person]"). It is scored on a 7-point Likert scale where 1 = less happy to 7 = more happy. Total scores range from 4 to 28 where higher scores indicate greater subjective happiness. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Secondary | Problematic and Risky Internet Use Screening Scale (PRIUSS-3) | The PRIUSS-3 is a 3-item scale where participants report their level of problematic internet use. It is scored on a 4-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 12, where higher scores indicate more problematic internet use. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and 3 month follow up |
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| Other Pre-specified | Inflammatory Biomarkers: C-reactive Protein (CRP) | Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from ~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1). | Data not provided or evaluable from all participants at all time points | Posted | Mean | Standard Deviation | mg/L | Baseline and 3 month follow-up |
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| Other Pre-specified | Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10 | Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from ~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1). | Data not provided or evaluable from all participants at all time points | Posted | Mean | Standard Deviation | pg/mL | Baseline and 3 month follow-up |
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| Other Pre-specified | Microbiome Alpha Diversity: Species Richness | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Reported here are the observed (total number of distinct taxa) and calculated (Chao1 = N + S2 / (2 D), where N is the number of observed OTUs (Operational Taxonomic Units), S is the number of singleton OTUs, and D is the number of doublet OTUs) number of species represented in the sample. Chao1 is a species richness calculator that accounts for rare species. | Some participants did not provide data at all time-points. | Posted | Mean | Standard Deviation | species | Baseline and 3 month follow-up |
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| Other Pre-specified | Microbiome Alpha Diversity: Shannon Diversity Index (H') | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Shannon Diversity Index quantifies both the richness and the evenness of a community. It takes into account the number of taxa (richness) and their relative abundances (evenness). A higher Shannon index value indicates greater diversity, with both a high number of taxa and more even distribution of abundances among them. It is often used to assess the balance between species in a community. Typically ranges from 0-5 with higher numbers indicating increasing species diversity. | Some participants did not provide data at all time-points. | Posted | Mean | Standard Deviation | H' index | Baseline and 3 month follow-up |
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| Other Pre-specified | Microbiome Alpha Diversity: Inverse Simpson (1/D) | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson is the probability that any two microbes are the same species, ranging from 0-1. Inverse Simpson (1 / Simpson) considers both richness and evenness. It places greater weight on the more abundant taxa. A higher inverse Simpson index suggests a more even distribution of taxa, with fewer dominant species. The inverse Simpson index is sensitive to the presence of dominant species and may emphasize diversity loss when one or a few species dominate the community. | Some participants did not provide data at all time-points. | Posted | Mean | Standard Deviation | 1/D index | Baseline and 3 month follow-up |
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| Other Pre-specified | Microbiome Alpha Diversity: Pielou Evenness Index (J) | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Pielou Evenness Index measures how evenly the individuals are distributed across the taxa in a sample. It is calculated by dividing the Shannon diversity index by the maximum possible value of the Shannon index (which occurs when all taxa are equally abundant). The Pielou index ranges from 0 (no evenness, where one species dominates) to 1 (perfect evenness, where all species are equally abundant). | Some participants did not provide data at all time-points. | Posted | Mean | Standard Deviation | J index | Baseline and 3 month follow-up |
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| Other Pre-specified | Microbiome Alpha Diversity: Simpson's Dominance Index (D) | Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson's Dominance Index measures the probability that two randomly selected individuals from a community belong to the same species (or taxon). It ranges from 0 to 1, where 0 indicates perfect diversity (no dominance of a single species) and values closer to 1 indicate that one or a few species dominate the community. A lower Simpson's dominance score suggests a more diverse community, while a higher score indicates a community dominated by a few taxa. | Some participants did not provide data at all time-points. | Posted | Mean | Standard Deviation | D index | Baseline and 3 month follow-up |
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| Other Pre-specified | Facial Behavior: Cheek Raise Score | Participants provide video recordings of their face while responding to a prompt watching brief videos of positive valence (e.g., baby giggling). Data are reported in Action Unit 6 (AU6) of Facial Action Coding System (FACS). FACS is an anatomically-based system for describing facial movement, breaking facial expressions into individual muscle movements called Action Units (AUs). The scores indicate the intensity of cheek movement (0-100), higher movements indicate more intense movement. | Some participants did not provide data at all time-points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Other Pre-specified | Lure Discrimination Task (LDI) | Meditation training has the capacity to normalize the overgeneralized inflexible cognition endemic to depression, which is hypothesized to relate to alterations in the hippocampal-dependent process of pattern separation. The investigators will use a pattern separation task to evaluate hippocampal function. The Lure Discrimination Task (LDI) is the difference between the probability of giving a "Similar" response to the lure items (similar to target items) minus the probability of giving a "Similar" response to the foils (unrelated to target items). Larger differences indicate increased discrimination. | Some participants did not provide data at all time-points. | Posted | Mean | Standard Deviation | Lure Discrimination Index | Baseline, week 4 (of intervention period), and 3 month follow-up |
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| Other Pre-specified | Self-Referential Pronoun Use | Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore indicators of self-referent, inflexible, & over-generalized thinking within natural language. Reported here is the "I" self-referential word frequency. | Some participants did not provide data at all time-points. | Posted | Mean | Standard Deviation | percent self referential words used | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Other Pre-specified | Negative Affect Word Use: Negative Sentiment | Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate more intense negative sentiment. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | percent negative words used | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Other Pre-specified | Negative Affect Word Use: Positive Sentiment | Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate greater positive sentiment. | Some participants did not provide data at all time points. | Posted | Mean | Standard Deviation | percent positive sentiment | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| Other Pre-specified | Treatment Expectancies | The Treatment Expectancies is a 6-item scale assessing how much participants believed the training program was helpful to them. Items assess how participants think (e.g., "At this point, how logical does the program offered to you seem?") and feel (e.g., "At this point, how much do you really feel that the program helped you to reduce your stress symptoms?"). Items are scored on either a 9-point Likert scale (e.g., 1 = "not at all logical" to 9 = "very logical") or on a percentage ("At the end of the program, how much improvement in your symptoms do you really feel occurred?", 0% to 100%). Higher scores reflect higher treatment expectancies. | The usual care arm was not surveyed for this measure per protocol. | Posted | Mean | Standard Deviation | score on a scale | 3-month follow-up |
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| Other Pre-specified | Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline | The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. Increase in scores indicates increase is depression symptoms. | Some participants did not provide data at all time-points. | Posted | Count of Participants | Participants | Week 1, Week 2, Week 3, Week 4, 3-month follow-up |
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| Other Pre-specified | Digital Working Alliance Inventory | The Digital Working Alliance Inventory is a 6-item scale where participants report their working alliance with the HMP app (e.g., "The HMP app supports me to overcome challenges"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 6 to 42 where higher scores indicate greater working alliance. | Some participants did not provide data at all time points. The usual care arm was not surveyed for this measure per protocol. | Posted | Mean | Standard Deviation | score on a scale | week 1, week 2, week 3, week 4, and 3-month follow-up |
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| Other Pre-specified | Inclusion of Nature in Self | The Inclusion of Nature in Self is a single item measure assessing the degree to which someone views nature as a part of their sense of self. Participants indicate which of a series of overlapping circles most closely resembles nature and their self. More overlapping circles indicate greater inclusion of nature in self. | Some participants did not provide data at all-time points. | Posted | Mean | Standard Deviation | overlapping circles | Baseline, week 4 (of intervention period), and 3 month follow-up |
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| Other Pre-specified | Mindfulness Adherence Questionnaire | The Mindfulness Adherence Questionnaire informal practice items are 6-items assessing the application of mindfulness during daily life (e.g., "In your daily life, how much of the time were you practicing being gentle and compassionate toward yourself?"). It is scored on a 7-point Likert scale where 0 = "never" to 6 = "always." Total scores range from 0 to 42 where higher scores indicate greater informal mindfulness practice. | Some participants did not provide data at all time points. The usual care arm was not surveyed for this measure per protocol. | Posted | Mean | Standard Deviation | score on a scale | week 1, week 2, week 3, week 4, and 3 month follow up |
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| Other Pre-specified | Change in Pre- and Post-practice Positive Affect | Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys. | The usual care arm was not surveyed for this measure per protocol. | Posted | Mean | Standard Deviation | score on a scale | Before and after HMP activities week 1, week 2, week 2, and week 4 | Surveys | Surveys |
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| Other Pre-specified | Change in Pre- and Post-practice Negative Affect | Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys. | The usual care arm was not surveyed for this measure per protocol. | Posted | Mean | Standard Deviation | score on a scale | Before and after HMP activities week 1, week 2, week 2, and week 4 | Surveys | Surveys |
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| Other Pre-specified | Change in Post-practice Focus | A single item assessing focus during HMP activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time. Data comes from multiple surveys. | Data collected only from HMP arm per protocol. | Posted | Mean | Standard Deviation | score on a scale | Before and after HMP activities week 1, week 2, week 2, and week 4 | Surveys | Surveys |
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| 0 |
| 462 |
| 0 |
| 462 |
| 78 |
| 462 |
| EG001 | Psychoeducation App | Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices. Healthy Minds Program: HMP is a 4-week mobile health (mHealth) meditation training program. | 0 | 463 | 0 | 463 | 64 | 463 |
| EG002 | Usual Care | Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. | 0 | 232 | 0 | 232 | 44 | 232 |
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| 3-month follow-up |
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| Week 4 |
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| 3-month follow-up |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| 3-month follow-up |
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| Change from Before and After Intervention Week 2 |
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| Change from Before and After Intervention Week 3 |
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| Change from Before and After Intervention Week 4 |
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| Change from Before and After Intervention Week 2 |
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| Change from Before and After Intervention Week 3 |
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| Change from Before and After Intervention Week 4 |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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