The Lucida Project

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:

• Does use of HMP reduce symptoms of depression?

Participants will complete a 4-week well-being program.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression Disorder
• Intervention / Treatment: Device: Healthy Minds Program; Behavioral: Healthy Minds Brian Games; Behavioral: Care as usual

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Effertz; Phone Number: 608-264-0396; Email: seffertz@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria - all participants:

• Age 18 to 84
• Elevated depressive symptoms: PHQ-9 ≥ 10; Healthy controls: PHQ-9 <5

Inclusion Criteria - randomized participants:

• Proficient in English to try to unsure understanding of study requirement, consent forms and questionnaires that can often us medical terms not routinely used in general conversation.
• Able to provide informed consent
• Have access to a smartphone that can download apps from Google Play or the Apple App Store
• Ability to receive text messages
• Indicate interest in participation after being informed of restrictions to payment

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 by PHQ-9 item 9 and BDI item 9)
• Self-reported history of psychosis
• Self-reported history of mania
• Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion)
• Hearing impairments
• Prior participation
• Self report pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care group	Behavioral: Care as usual; Care as usual
Experimental: Healthy Minds Program (HMP); Participants will use HMP	Device: Healthy Minds Program; A mobile health meditation training program.
Active Comparator: Active control group; Participants will play mental games	Behavioral: Healthy Minds Brian Games; Typescript-based games installed as a web application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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
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
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Jo Handelsman, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-1864; Protocol Version 5/1/26 (Other Identifier: UW Madison); GR000045260 (Other Grant/Funding Number: Advanced Research Projects Agency for Health (ARPA-H)); UWMSN | CALS | Plant Pathology (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be shared.
• IPD Sharing Time Frame: IPD will be available upon reasonable request after study completion.
• IPD Sharing Access Criteria: Requests will be reviewed by the study PI, and data will be shared under a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No