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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 pilot study is to compare markers of inflammation and gut microbial diversity with users 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 300 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 mediation 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.
Specific Aims:
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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. |
|
| 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. |
|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants. | Baseline and 3 month follow-up |
| Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants. | Baseline and 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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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| Label | URL |
|---|---|
| FULL Behavior, Biology and Well-Being Study | View source |
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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. |
| 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. |
| 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 | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 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. |
| 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 | Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS | Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants. | Posted | Count of Participants | Participants | Baseline and 3 month follow-up |
|
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 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Symptoms of Depression | Psychiatric disorders | Systematic Assessment | Participants report how often in the past 2 weeks they were bothered by specific problems. 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 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The groups will be randomized to one of three groups in a 2:2:1 ratio.
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| Psychoeducation app | Other | Psychoeducation app |
|
| Baseline and 3 month follow-up |
| Change in 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 |
| Change in 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 |
| Change in 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 |
| Change in 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 |
| Change in Inflammatory Biomarkers: C-reactive Protein | Dried blood spot samples will be used to measure 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 |
| Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | Dried blood spot samples will be used to measure 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 |
| Change in 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 |
| Change in 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 |
| 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. |
| 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 |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Non-Hispanic White: Psychoeducation App | Active Control - 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. |
| OG003 | Racial / Ethnic Minority: Psychoeducation App | Active Control - 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. |
| OG004 | Non-Hispanic: Usual Care | Usual Care: Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. |
| OG005 | Racial / Ethnic Minority: Usual Care | Usual Care: Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. |
|
|
| Primary | Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples | Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants. | Posted | Count of Participants | Participants | Baseline and 3 month follow-up |
|
|
|
| Secondary | Change in 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. | Samples were not received from all participants at all time points. | Posted | Mean | Standard Deviation | species | Baseline and 3 month follow-up |
|
|
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| Secondary | Change in 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. | Samples were not received from all participants at all time points. | Posted | Mean | Standard Deviation | H' index | Baseline and 3 month follow-up |
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| Secondary | Change in 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. | Samples were not received from all participants at all time points. | Posted | Mean | Standard Deviation | 1/D index | Baseline and 3 month follow-up |
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| Secondary | Change in 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). | Samples were not received from all participants at all time points. | Posted | Mean | Standard Deviation | J index | Baseline and 3 month follow-up |
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| Secondary | Change in 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. | Samples were not received from all participants at all time points. | Posted | Mean | Standard Deviation | D index | Baseline and 3 month follow-up |
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| Secondary | Change in Inflammatory Biomarkers: C-reactive Protein | Dried blood spot samples will be used to measure 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). | only those who return their samples at both time points were included | Posted | Mean | Standard Deviation | mg/L | Baseline and 3 month follow-up |
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| Secondary | Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 | Dried blood spot samples will be used to measure 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). | only those who return their samples at both time points were included | Posted | Mean | Standard Deviation | pg/mL | Baseline and 3 month follow-up |
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| Secondary | Change in 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. | Survey participation dropped over time. | 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 | Change in 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. | Survey participation dropped over time. | 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 | 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. | Survey participation dropped over time. | Posted | Count of Participants | Participants | Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up |
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| 0 |
| 120 |
| 0 |
| 120 |
| 24 |
| 120 |
| 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. | 0 | 122 | 0 | 122 | 15 | 122 |
| 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 | 58 | 0 | 58 | 10 | 58 |
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| Return Rate at 3-month follow up |
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| Return Rate both time points |
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| Observed at 3-month follow up |
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| Calculated at baseline |
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| Calculated at 3-month follow up |
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| diversity at 3-month follow up |
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| Inverse Simpson at 3-month follow up |
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| Evenness Pielou at 3-month follow up |
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| Simpson's Dominance at 3-month follow up |
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| 3-month follow up |
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| TNF-Alpha 3-month follow up |
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| IL-6 baseline |
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| IL-6 3-month follow up |
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| IL-10 baseline |
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| IL-10 3-month follow up |
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| Week 4 |
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| 3-month follow up |
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| Week 3 |
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| Week 4 |
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| 3-month follow up |
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| baseline to Week 2 |
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| baseline to Week 3 |
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| baseline to Week 4 |
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| baseline to 3-month follow up |
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