Depression DisorderNCT07678242
The Lucida Project
A study testing Healthy Minds Program, Healthy Minds Brian Games and Care as usual in people with Depression Disorder, run by University of Wisconsin, Madison.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Disorder
- What is being tested?
- Healthy Minds Program, Healthy Minds Brian Games and Care as usual
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 84
- Elevated depressive symptoms: PHQ-9 ≥ 10; Healthy controls: PHQ-9 <5
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Depression Disorder
- Being tested
- Healthy Minds Program, Healthy Minds Brian Games, Care as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Minds ProgramDevice
A mobile health meditation training program.
Healthy Minds Brian GamesBehavioural
Typescript-based games installed as a web application
Care as usualBehavioural
Care as usual
| Study group | Role | What they receive |
|---|---|---|
| Healthy Minds Program (HMP) | Experimental | Participants will use HMP Receives: Device: Healthy Minds Program |
| Active control group | Active comparator | Participants will play mental games Receives: Behavioral: Healthy Minds Brian Games |
| Usual care group | Active comparator | Not described Receives: Behavioral: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months
Change in self-referential thought
Measured using a video recording task
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start16 Nov 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jo Handelsman, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678242
- Sponsor's protocol ID
- 2025-1864
- Other IDs
- GR000045260, UWMSN | CALS | Plant Pathology, Protocol Version 5/1/26
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lucida Project
- ClinicalTrials.gov ID
- NCT07678242
- Acronym / sponsor ID
- 2025-1864
- Conditions
- Depression Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Minds Program (HMP) | Experimental | Device: Healthy Minds ProgramParticipants will use HMP |
| Active control group | Active comparator | Behavioral: Healthy Minds Brian GamesParticipants will play mental games |
| Usual care group | Active comparator | Behavioral: Care as usual |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 84
- Elevated depressive symptoms: PHQ-9 ≥ 10; Healthy controls: PHQ-9 <5
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Minds ProgramA mobile health meditation training program. | Device | Healthy Minds Program (HMP) |
| Healthy Minds Brian GamesTypescript-based games installed as a web application | Behavioural | Active control group |
| Care as usualCare as usual | Behavioural | Usual care group |
Primary outcome
Change in Physical Health Questionnaire depression scale (PHQ-9)
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months
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.
8 secondary outcomes
Change in Generalized Anxiety Disorder (GAD-7) score
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months
Change in Flourishing Measure
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months
Change in PROMIS Sleep Disturbance
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months
Change in performance on the behavioral Self-Referential Encoding Task (SRET)
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months
Change in self-referential thought
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months
Inflammatory Biomarkers: C-reactive Protein (CRP)
Time frame: Baseline and 3 month follow-up
Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10
Time frame: Baseline and 3 month follow-up
Microbiome Alpha Diversity: Species Richness
Time frame: Baseline and 3 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jo Handelsman, PhD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Minds Program, Healthy Minds Brian Games and Care as usual in people with Depression Disorder, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Effertz (608-264-0396, seffertz@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Health Questionnaire depression scale (PHQ-9) (time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.