Well-being Training for Adolescent Depressive Symptoms (TeenWell Study)

NCT ID: NCT06626425

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-07

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Participants will be randomized into one of two groups: Healthy Minds Program intervention group (HMP) or a water tracking active control group. The groups will use different mobile health apps for eight weeks. All participants will complete assessments pre-intervention, after weeks 2, 4, and 6 of the intervention, at week 8 (post-intervention), and at week 20 (follow-up). Participants will complete a short daily diary set of questions on their social interactions that day. Participants will wear a Biostrap band for continuous collection of heart rate, movement, and daily sleep indices, and geolocation data will be extracted from participant phones using the FollowMee app. Participants will receive access to the app they were not assigned to after follow-up.

Primary Objective

* Assess acceptability and preliminary efficacy of an 8-week mHealth meditation training program on depressive symptoms.

Secondary Objectives

* Investigate effects of the meditation training program on symptoms of anxiety, behavior (social isolation), psychophysiological processes related to health and disease (e.g., sleep). Test changes in behavior and psychophysiology as mechanisms of improved mental health. Test whether improved mental health is associated with improved academic outcomes.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized active-controlled wait-list trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Healthy Minds Program (HMP) App

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

Group Type EXPERIMENTAL

Healthy Minds Program App

Intervention Type OTHER

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.

Hydro Coach active control group (HC)

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.

Group Type ACTIVE_COMPARATOR

Hydro Coach App

Intervention Type OTHER

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

Interventions

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Healthy Minds Program App

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.

Intervention Type OTHER

Hydro Coach App

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

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

1. Has received a high school diploma or a high school equivalency diploma (HSED or GED)
2. Weekly or more frequent meditation practice
3. Prior use of the Healthy Minds Program app
4. Prior use of the water tracking app
5. Endorses current active suicidal ideation with intent on the baseline screen
6. Self-reported history of psychosis or mania
7. 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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Hirshberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Healthy Minds, UW Madison

Locations

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Center for Healthy Minds, University of Wisconsin Madison

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew Hirshberg, PhD

Role: CONTACT

(608) 262-0035

Facility Contacts

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Roxanne Hoks Research Program Manager, BA

Role: primary

608-265-2596

Other Identifiers

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1K01MH130752-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A483000

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 5/22/25

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0554

Identifier Type: -

Identifier Source: org_study_id

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