Trial Outcomes & Findings for Behavior, Biology and Well-Being Study (NCT NCT06213701)
NCT ID: NCT06213701
Last Updated: 2025-07-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
Baseline and 3 month follow-up
Results posted on
2025-07-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Overall Study
STARTED
|
120
|
122
|
58
|
|
Overall Study
COMPLETED
|
118
|
121
|
58
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Usual Care
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
Baseline Characteristics
Behavior, Biology and Well-Being Study
Baseline characteristics by cohort
| Measure |
Healthy Minds Program (HMP) App
n=120 Participants
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.
|
Psychoeducation App
n=122 Participants
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
n=58 Participants
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.26 years
STANDARD_DEVIATION 11.77 • n=5 Participants
|
38.70 years
STANDARD_DEVIATION 11.76 • n=7 Participants
|
43.57 years
STANDARD_DEVIATION 12.00 • n=5 Participants
|
40.26 years
STANDARD_DEVIATION 11.90 • n=4 Participants
|
|
Sex/Gender, Customized
Man
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Woman
|
94 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Not Provided
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
90 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Racial/Ethnic Minority
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
122 participants
n=7 Participants
|
58 participants
n=5 Participants
|
300 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 month follow-upFeasibility 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.
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=90 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=30 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=98 Participants
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.
|
Racial / Ethnic Minority: Psychoeducation App
n=24 Participants
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.
|
Non-Hispanic: Usual Care
n=38 Participants
Usual Care: Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
Racial / Ethnic Minority: Usual Care
n=20 Participants
Usual Care: Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|---|---|---|
|
Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS
Return Rate at Baseline
|
89 Participants
|
29 Participants
|
98 Participants
|
24 Participants
|
38 Participants
|
19 Participants
|
|
Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS
Return Rate at 3-month Follow up
|
68 Participants
|
23 Participants
|
72 Participants
|
20 Participants
|
31 Participants
|
16 Participants
|
|
Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS
Return Rate for both time points
|
68 Participants
|
23 Participants
|
72 Participants
|
20 Participants
|
31 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 month follow-upFeasibility 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.
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=90 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=30 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=98 Participants
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.
|
Racial / Ethnic Minority: Psychoeducation App
n=24 Participants
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.
|
Non-Hispanic: Usual Care
n=38 Participants
Usual Care: Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
Racial / Ethnic Minority: Usual Care
n=20 Participants
Usual Care: Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|---|---|---|
|
Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples
Return Rate at Baseline
|
90 Participants
|
30 Participants
|
98 Participants
|
24 Participants
|
37 Participants
|
20 Participants
|
|
Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples
Return Rate at 3-month follow up
|
69 Participants
|
24 Participants
|
72 Participants
|
20 Participants
|
30 Participants
|
17 Participants
|
|
Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples
Return Rate both time points
|
69 Participants
|
24 Participants
|
72 Participants
|
20 Participants
|
29 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 month follow-upPopulation: Samples were not received from all participants at all time points.
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.
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=91 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=92 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=46 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change in Microbiome Alpha Diversity: Species Richness
Observed at baseline
|
261.47 species
Standard Deviation 143.66
|
271.59 species
Standard Deviation 139.46
|
294.22 species
Standard Deviation 130.35
|
—
|
—
|
—
|
|
Change in Microbiome Alpha Diversity: Species Richness
Observed at 3-month follow up
|
257.34 species
Standard Deviation 133.74
|
278.55 species
Standard Deviation 143.96
|
295.67 species
Standard Deviation 148.78
|
—
|
—
|
—
|
|
Change in Microbiome Alpha Diversity: Species Richness
Calculated at baseline
|
261.64 species
Standard Deviation 143.82
|
271.84 species
Standard Deviation 139.52
|
294.98 species
Standard Deviation 130.68
|
—
|
—
|
—
|
|
Change in Microbiome Alpha Diversity: Species Richness
Calculated at 3-month follow up
|
257.57 species
Standard Deviation 133.91
|
278.75 species
Standard Deviation 144.07
|
295.96 species
Standard Deviation 148.76
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 month follow-upPopulation: Samples were not received from all participants at all time points.
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.
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=91 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=92 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=46 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change in Microbiome Alpha Diversity: Shannon Diversity Index (H')
diversity at baseline
|
4.28 H' index
Standard Deviation 0.78
|
4.28 H' index
Standard Deviation 0.74
|
4.35 H' index
Standard Deviation 0.72
|
—
|
—
|
—
|
|
Change in Microbiome Alpha Diversity: Shannon Diversity Index (H')
diversity at 3-month follow up
|
4.26 H' index
Standard Deviation 0.76
|
4.33 H' index
Standard Deviation 0.74
|
4.40 H' index
Standard Deviation 0.73
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 month follow-upPopulation: Samples were not received from all participants at all time points.
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.
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=91 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=92 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=46 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change in Microbiome Alpha Diversity: Inverse Simpson (1/D)
Inverse Simpson at baseline
|
62.75 1/D index
Standard Deviation 80.39
|
62.18 1/D index
Standard Deviation 77.51
|
60.73 1/D index
Standard Deviation 70.38
|
—
|
—
|
—
|
|
Change in Microbiome Alpha Diversity: Inverse Simpson (1/D)
Inverse Simpson at 3-month follow up
|
62.23 1/D index
Standard Deviation 78.81
|
64.07 1/D index
Standard Deviation 75.86
|
66.58 1/D index
Standard Deviation 75.16
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 month follow-upPopulation: Samples were not received from all participants at all time points.
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).
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=91 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=92 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=46 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change in Microbiome Alpha Diversity: Pielou Evenness Index (J)
Evenness Pielou baseline
|
0.78 J index
Standard Deviation 0.09
|
0.78 J index
Standard Deviation 0.09
|
0.78 J index
Standard Deviation 0.09
|
—
|
—
|
—
|
|
Change in Microbiome Alpha Diversity: Pielou Evenness Index (J)
Evenness Pielou at 3-month follow up
|
0.78 J index
Standard Deviation 0.09
|
0.79 J index
Standard Deviation 0.09
|
0.79 J index
Standard Deviation 0.09
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 month follow-upPopulation: Samples were not received from all participants at all time points.
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.
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=91 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=92 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=46 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D)
Simpson's Dominance at baseline
|
0.03 D index
Standard Deviation 0.02
|
0.04 D index
Standard Deviation 0.03
|
0.03 D index
Standard Deviation 0.03
|
—
|
—
|
—
|
|
Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D)
Simpson's Dominance at 3-month follow up
|
0.04 D index
Standard Deviation 0.02
|
0.03 D index
Standard Deviation 0.02
|
0.03 D index
Standard Deviation 0.02
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 month follow-upPopulation: only those who return their samples at both time points were included
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).
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=91 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=92 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=47 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change in Inflammatory Biomarkers: C-reactive Protein
baseline
|
2.26 mg/L
Standard Deviation 4.17
|
2.40 mg/L
Standard Deviation 3.46
|
2.98 mg/L
Standard Deviation 4.67
|
—
|
—
|
—
|
|
Change in Inflammatory Biomarkers: C-reactive Protein
3-month follow up
|
2.62 mg/L
Standard Deviation 4.44
|
3.28 mg/L
Standard Deviation 5.30
|
3.10 mg/L
Standard Deviation 4.33
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 month follow-upPopulation: only those who return their samples at both time points were included
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).
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=91 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=92 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=47 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10
TNF-Alpha baseline
|
2.01 pg/mL
Standard Deviation 5.58
|
1.54 pg/mL
Standard Deviation 0.88
|
1.66 pg/mL
Standard Deviation 0.67
|
—
|
—
|
—
|
|
Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10
TNF-Alpha 3-month follow up
|
1.73 pg/mL
Standard Deviation 0.93
|
1.87 pg/mL
Standard Deviation 0.84
|
1.98 pg/mL
Standard Deviation 1.15
|
—
|
—
|
—
|
|
Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10
IL-6 baseline
|
1.79 pg/mL
Standard Deviation 13.20
|
0.26 pg/mL
Standard Deviation 0.20
|
0.34 pg/mL
Standard Deviation 0.39
|
—
|
—
|
—
|
|
Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10
IL-6 3-month follow up
|
0.98 pg/mL
Standard Deviation 6.58
|
0.42 pg/mL
Standard Deviation 0.83
|
0.98 pg/mL
Standard Deviation 4.10
|
—
|
—
|
—
|
|
Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10
IL-10 baseline
|
0.11 pg/mL
Standard Deviation 0.12
|
0.10 pg/mL
Standard Deviation 0.14
|
0.08 pg/mL
Standard Deviation 0.07
|
—
|
—
|
—
|
|
Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10
IL-10 3-month follow up
|
0.13 pg/mL
Standard Deviation 0.18
|
0.16 pg/mL
Standard Deviation 0.26
|
0.11 pg/mL
Standard Deviation 0.09
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Survey participation dropped over time.
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.
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=120 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=122 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=58 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Baseline
|
9.80 score on a scale
Standard Deviation 4.74
|
9.91 score on a scale
Standard Deviation 5.03
|
9.45 score on a scale
Standard Deviation 4.57
|
—
|
—
|
—
|
|
Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Week 1
|
9.53 score on a scale
Standard Deviation 5.02
|
9.30 score on a scale
Standard Deviation 5.10
|
9.35 score on a scale
Standard Deviation 4.70
|
—
|
—
|
—
|
|
Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Week 2
|
8.06 score on a scale
Standard Deviation 4.87
|
8.35 score on a scale
Standard Deviation 4.79
|
8.77 score on a scale
Standard Deviation 4.49
|
—
|
—
|
—
|
|
Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Week 3
|
7.78 score on a scale
Standard Deviation 4.68
|
7.88 score on a scale
Standard Deviation 4.87
|
9.14 score on a scale
Standard Deviation 4.43
|
—
|
—
|
—
|
|
Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Week 4
|
7.17 score on a scale
Standard Deviation 4.89
|
7.44 score on a scale
Standard Deviation 4.94
|
8.98 score on a scale
Standard Deviation 4.38
|
—
|
—
|
—
|
|
Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
3-month follow up
|
6.78 score on a scale
Standard Deviation 4.99
|
7.26 score on a scale
Standard Deviation 5.13
|
7.81 score on a scale
Standard Deviation 4.54
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Survey participation dropped over time.
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.
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=120 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=122 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=58 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Change in Flourishing Measured by the Flourishing Index Score
Baseline
|
55.61 score on a scale
Standard Deviation 16.47
|
56.4 score on a scale
Standard Deviation 16.75
|
57.14 score on a scale
Standard Deviation 16.54
|
—
|
—
|
—
|
|
Change in Flourishing Measured by the Flourishing Index Score
Week 1
|
56.31 score on a scale
Standard Deviation 17.51
|
56.5 score on a scale
Standard Deviation 14.36
|
57.62 score on a scale
Standard Deviation 14.02
|
—
|
—
|
—
|
|
Change in Flourishing Measured by the Flourishing Index Score
Week 2
|
60.39 score on a scale
Standard Deviation 16.01
|
59.19 score on a scale
Standard Deviation 14.92
|
57.26 score on a scale
Standard Deviation 16.01
|
—
|
—
|
—
|
|
Change in Flourishing Measured by the Flourishing Index Score
Week 3
|
62.11 score on a scale
Standard Deviation 16.65
|
61.12 score on a scale
Standard Deviation 15.53
|
57.65 score on a scale
Standard Deviation 15.35
|
—
|
—
|
—
|
|
Change in Flourishing Measured by the Flourishing Index Score
Week 4
|
63.64 score on a scale
Standard Deviation 17.73
|
63.31 score on a scale
Standard Deviation 15.75
|
59.10 score on a scale
Standard Deviation 15.85
|
—
|
—
|
—
|
|
Change in Flourishing Measured by the Flourishing Index Score
3-month follow up
|
65.01 score on a scale
Standard Deviation 18.34
|
63.47 score on a scale
Standard Deviation 16.84
|
61.48 score on a scale
Standard Deviation 14.09
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-upPopulation: Survey participation dropped over time.
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.
Outcome measures
| Measure |
Non-Hispanic White: HMP App
n=120 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Racial / Ethnic Minority: HMP App
n=122 Participants
Study Intervention - Participants will receive access to the 4-week HMP Foundations module.
|
Non-Hispanic White: Psychoeducation App
n=58 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
baseline to Week 3
|
9 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
baseline to Week 4
|
8 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
baseline to 3-month follow up
|
8 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
baseline to Week 1
|
11 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline
baseline to Week 2
|
7 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
Adverse Events
Healthy Minds Program (HMP) App
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Psychoeducation App
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Minds Program (HMP) App
n=120 participants at risk
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.
|
Psychoeducation App
n=122 participants at risk
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
n=58 participants at risk
Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.
|
|---|---|---|---|
|
Psychiatric disorders
Increased Symptoms of Depression
|
20.0%
24/120 • data collected up to 4 months on study
|
12.3%
15/122 • data collected up to 4 months on study
|
17.2%
10/58 • data collected up to 4 months on study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place