NCT07051330

Brief Summary

This study aims to enhance the Healthy Minds Program (HMP) app by developing and testing a personalized, data-driven approach to optimize long-term well-being. 1100 participants will be enrolled and on study for up to 4 months (4 week intervention plus 3 month follow-up).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,553

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

July 20, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

June 24, 2025

Last Update Submit

September 14, 2026

Conditions

Keywords

personalized well-beingHMP appHealthy Minds Program

Outcome Measures

Primary Outcomes (1)

  • Change in PHQ-9

    PHQ-9 is a 9 item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale, where 0=not at all and 4=nearly every day. Scores range from 0-36, where higher scores indicate more depressive symptoms.

    Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)

Secondary Outcomes (27)

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression

    Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)

  • Change in PROMIS Anxiety Score

    Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)

  • Acceptability of Intervention Measure

    week 4 (of intervention period)

  • Change in Growth Mindset Scale for Well-Being

    Baseline, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)

  • HMP engagement measure

    Week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)

  • +22 more secondary outcomes

Other Outcomes (6)

  • Change in Beck Depression Inventory Item 9 Score

    Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)

  • Change in Mindfulness-Based Program - Meditation-Related Adverse Effects Scale (MBP-MRAES)

    week 4 (of intervention period), and 3 month follow-up (up to 4 months on study)

  • Lasting Effects Questionnaire

    3-month follow-up (up to 4 months on study)

  • +3 more other outcomes

Study Arms (6)

Introduction Video to HMP app

EXPERIMENTAL

All participants are randomized to this condition (Yes or No)

Other: Healthy Minds Program (HMP) app

Introduction Video to Training Modules

EXPERIMENTAL

All participants are randomized to this condition (Yes or No)

Other: Healthy Minds Program (HMP) app

Module Order based on ACIP Score

EXPERIMENTAL

All participants are randomized to this condition (Highest score first or Lowest score first)

Other: Healthy Minds Program (HMP) app

Practice-Nudging Test Messages

EXPERIMENTAL

All participants are randomized to this condition (Yes or No)

Other: Healthy Minds Program (HMP) app

Microsupport Messages During Intervention

EXPERIMENTAL

All participants are randomized to this condition (Yes or No)

Other: Healthy Minds Program (HMP) app

Microsupport Messages During Follow-Up

EXPERIMENTAL

All participants are randomized to this condition (Yes or No)

Other: Healthy Minds Program (HMP) app

Interventions

All participants will complete baseline surveys, weekly questionnaires (for 4 weeks) through the HMP app intervention, and will be surveyed again at 3-months post-intervention. Participants are randomized to each of the following binary conditions. 1. Introduction video for the app (yes / no) 2. Introduction video for the training modules (yes / no) 3. Module order based on ACIP score (highest-first / lowest-first) 4. Practice-nudging text messages (yes / no) 5. Microsupport messages during the intervention period (yes / no) 6. Microsupport messages during the follow-up period (yes / no

Also known as: HMP app
Introduction Video to HMP appIntroduction Video to Training ModulesMicrosupport Messages During Follow-UpMicrosupport Messages During InterventionModule Order based on ACIP ScorePractice-Nudging Test Messages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elevated symptoms of depression (PHQ-9 greater than or equal to 5)
  • proficiency in English
  • access to a smartphone and internet
  • ability to receive text messages

You may not qualify if:

  • Prior experience with meditation
  • Prior use of the Healthy Minds Program app
  • History of psychosis or mania
  • Plans to travel in the next six weeks
  • Suicidal ideation or thoughts of self-harm indicated by PHQ-9 item 9 and BDI item 9
  • Failure to select the correct code word mentioned in the welcome video
  • Not a US citizen
  • Non-permanent resident
  • Self-identification as artificial intelligence (AI)
  • Has a hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Healthy Minds

Madison, Wisconsin, 53703, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Simon Goldberg, PhD

    Center for Healthy Minds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Goldberg, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: Participants are randomized to six different binary conditions. The investigators plan to collapse the groups for analysis, for example, combining participants with or without the introduction videos, regardless of their other assigned conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 4, 2025

Study Start

July 20, 2025

Primary Completion

September 1, 2026

Study Completion

September 1, 2026

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified data will be shared electronically (e.g., posted on the Open Science Framework). Confidentiality will be protected by stripping the data of all identifiers, including HIPAA identifiers.

Locations