NCT06626425

Brief Summary

This study is being done to see if the Healthy Minds Program app helps adolescents with elevated depressive symptoms. Up to 200 participants will be on study for 20 weeks.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
8mo left

Started Dec 2024

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

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Study Timeline

Key milestones and dates

Study Progress68%
Dec 2024Jan 2027

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 7, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 7, 2026

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

October 1, 2024

Last Update Submit

January 5, 2026

Conditions

Depression

Keywords

adolescentmeditation

Outcome Measures

Primary Outcomes (1)

  • PROMIS Pediatric Depression T-Scores

    Efficacy will be measured with the PROMIS Pediatric Item Bank (version 3.0) Depressive Symptoms Short Form 8a survey which results in T-scores where a score of less than 55 = None to slight depression, 55.0-59.9 = Mild depression, 60.0-69.9 = Moderate depression, 70 and over = Severe depression.

    8 weeks, 20 weeks

Secondary Outcomes (15)

  • PROMIS Pediatric Anxiety T-Scores

    8 weeks, 20 weeks

  • EPOCH Wellbeing Scores

    8 weeks, 20 weeks

  • PROMIS Pediatric Sleep Disturbance T-Score

    8 weeks, 20 weeks

  • Sleep Duration assessed with wearable device

    Daily through 20 weeks

  • Sleep Staging assessed with wearable device

    Daily through 20 weeks

  • +10 more secondary outcomes

Other Outcomes (4)

  • Digital Working Alliance Inventory

    Weeks 2, 4, 6, 8 and 20.

  • Growth mindset personality and intelligence

    Baseline, week 8 and week 20.

  • Problematic Internet Use Scale

    Baseline, week 8 and week 20

  • +1 more other outcomes

Study Arms (2)

Healthy Minds Program (HMP) App

EXPERIMENTAL

The HMP is a smartphone meditation-based well-being training.

Other: Healthy Minds Program App

Hydro Coach active control group (HC)

ACTIVE COMPARATOR

The water tracking app is a publicly available, user-designed hydration app that prompts users to enter in daily liquid consumption and provides optimized hydration recommendations based on user input.

Other: Hydro Coach App

Interventions

Healthy Minds Program AppOTHER

An 8-week meditation-based well-being training containing content for each of the four pillars of the training program: Awareness, Connection, Insight, and Purpose.

Healthy Minds Program (HMP) App
Hydro Coach AppOTHER

The Hydro Coach app (HC). A smartphone-based wellness app to ensure proper hydration.

Hydro Coach active control group (HC)

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Has received a high school diploma or a high school equivalency diploma (HSED or GED)
  • Weekly or more frequent meditation practice
  • Prior use of the Healthy Minds Program app
  • Prior use of the water tracking app
  • Endorses current active suicidal ideation with intent on the baseline screen
  • Self-reported history of psychosis or mania
  • Practiced the techniques learned in a mindfulness-based therapy Acceptance Commitment Therapy (ACT), Dialectical Behavior Therapy (DBT), Mindfulness-Based Stress Reduction (MBSR) etc. one or more times per week in the last 6 months. Include therapy sessions if mindfulness is practiced in session or planning to start one of these therapies during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Healthy Minds, University of Wisconsin Madison

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Matthew Hirshberg, PhD

    Center for Healthy Minds, UW Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Hirshberg, PhD

CONTACT

(608) 262-0035hirshberg@wisc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized active-controlled wait-list trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

December 7, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 7, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data from this study may be requested from other researchers 2 years after the completion of the primary endpoint by contacting the PI or accessing the data on osf.io.

Locations

US(1)