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NCT Number: NCT07678242

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.

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Key information

Conditions

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Minds Program

Device

A mobile health meditation training program.

Healthy Minds Brian Games

Behavioral

Typescript-based games installed as a web application

Care as usual

Behavioral

Care as usual

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Generalized Anxiety Disorder (GAD-7) score

    Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months

    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.

  2. Change in Flourishing Measure

    Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months

    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.

  3. Change in PROMIS Sleep Disturbance

    Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months

    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.

  4. Change in performance on the behavioral Self-Referential Encoding Task (SRET)

    Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months

    The SRET is a cognitive-behavioral paradigm used to measure how individuals process and recall information relating to themselves.

  5. Change in self-referential thought

    Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months

    Measured using a video recording task

  6. Inflammatory Biomarkers: C-reactive Protein (CRP)

    Time frame: Baseline and 3 month follow-up

    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).

  7. Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10

    Time frame: Baseline and 3 month follow-up

    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).

  8. Microbiome Alpha Diversity: Species Richness

    Time frame: Baseline and 3 month follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Effertz

CONTACT

[email protected]

608-264-0396

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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