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Not yet recruiting NCT07678242

The Lucida Project

No phase Interventional Depression Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healthy Minds Program, Healthy Minds Brian Games, Care as usual.
Who it may be relevant to
Registry conditions: Depression Disorder. Basic parameters: 18 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Healthy Minds Program
    A mobile health meditation training program.
  • Behavioral Healthy Minds Brian Games
    Typescript-based games installed as a web application
  • Behavioral Care as usual
    Care as usual

Primary outcome measures

  • Change in Physical Health Questionnaire depression scale (PHQ-9) [Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07678242 · 2025-1864 · GR000045260 · UWMSN | CALS | Plant Pathology · Protocol Version 5/1/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗