The Lucida Project

NCT07678242 | Not Yet Recruiting DMC FDA Device

• 4 other identifiers: 2025-1864GR000045260UWMSN | CALS | Plant PathologyProtocol Version 5/1/26
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depression Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Generalized Anxiety Disorder (GAD-7) score

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months

• Change in Flourishing Measure

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months

• Change in PROMIS Sleep Disturbance

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months

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

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months

• Change in self-referential thought

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 3 months

Study Arms (3)

Healthy Minds Program (HMP)

EXPERIMENTAL

Participants will use HMP

Device: Healthy Minds Program

Active control group

ACTIVE COMPARATOR

Participants will play mental games

Behavioral: Healthy Minds Brian Games

Usual care group

ACTIVE COMPARATOR

Behavioral: Care as usual

Interventions

Healthy Minds Program DEVICE

A mobile health meditation training program.

Healthy Minds Program (HMP)

Healthy Minds Brian Games BEHAVIORAL

Typescript-based games installed as a web application

Active control group

Care as usual BEHAVIORAL

Care as usual

Usual care group

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Hearing impairments
• Prior participation
• Self report pregnancy

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Officials

• Jo Handelsman, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Effertz

CONTACT

608-264-0396; seffertz@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available upon reasonable request after study completion.
• Access Criteria: Requests will be reviewed by the study PI, and data will be shared under a data use agreement.