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| ID | Type | Description | Link |
|---|---|---|---|
| GR000045260 | Other Grant/Funding Number | Advanced Research Projects Agency for Health (ARPA-H) | |
| UWMSN | CALS | Plant Pathology | Other Identifier | UW Madison | |
| Protocol Version 5/1/26 | Other Identifier | UW Madison |
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The purpose of this clinical trial is to learn about the impact of the Healthy Minds Program (HMP) on measurements of well-being. The main question it aims to answer is:
Participants will complete a 4-week well-being program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Minds Program (HMP) | Experimental | Participants will use HMP |
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| Active control group | Active Comparator | Participants will play mental games |
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| Usual care group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Minds Program | Device | A mobile health meditation training program. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Health Questionnaire depression scale (PHQ-9) | The PHQ-9 is a 9-question screening tool used to assess depression severity. Each of the 9 items evaluates symptoms over the last 2 weeks and is scored from 0 (not at all) to 3 (nearly every day), resulting in a total possible score ranging from 0 to 27. Higher scores indicate higher depression severity. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Generalized Anxiety Disorder (GAD-7) score | The GAD-7 is a 7-item tool used to screen for Generalized Anxiety Disorder and assess symptom severity. Respondents rate how often they've been bothered by anxiety symptoms over the past two weeks on a scale of 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, where higher scores indicate greater levels of anxiety. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months |
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Inclusion Criteria - all participants:
Inclusion Criteria - randomized participants:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Effertz | Contact | 608-264-0396 | seffertz@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jo Handelsman, PhD | University of Wisconsin, Madison | Principal Investigator |
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De-identified individual participant data will be shared.
IPD will be available upon reasonable request after study completion.
Requests will be reviewed by the study PI, and data will be shared under a data use agreement.
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| Healthy Minds Brian Games |
| Behavioral |
Typescript-based games installed as a web application |
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| Care as usual | Behavioral | Care as usual |
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| Change in Flourishing Measure | This is a 12-item questionnaire used to assess various domains of flourishing, or human well-being. It is scored on a 0- to 10-point Likert scale where 0 = poor and 10 = excellent. Mean scores are reported for a range from 0 to 120 where higher scores indicate greater human well-being. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months |
| Change in PROMIS Sleep Disturbance | Sleep disturbance will be assessed using the computer adaptive version of the PROMIS Sleep Disturbance measure. This measure produces scores a T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate greater sleep disturbance. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months |
| Change in performance on the behavioral Self-Referential Encoding Task (SRET) | The SRET is a cognitive-behavioral paradigm used to measure how individuals process and recall information relating to themselves. | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months |
| Change in self-referential thought | Measured using a video recording task | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months |
| 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). | 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 |