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

University of Wisconsin (UW)

Status: Enrolling

Conditions: Depression

Treatments: Other: Healthy Minds Program App; Other: Hydro Coach App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06626425

2023-0554

1K01MH130752-01A1 (U.S. NIH Grant/Contract)

A483000 (Other Identifier)

Protocol Version 5/22/25 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 14 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Age 14 to 19
2. Currently in high school (i.e., 9th to 12th grade) or if not attending school, would be in high school if enrolled
3. Proficient in English
4. Able to understand and provide informed consent (greater than or equal to 18 years old) or assent and parent/guardian consent (if less than 18 years old)
5. PROMIS Depression Scale T-score greater than or equal to 60
6. If on a psychotropic meditation, has been receiving a stable dose for greater than or equal to 4 weeks
7. Willing and able to complete all study procedures

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Healthy Minds Program (HMP) App

Experimental group

Description:

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

Treatment:

Other: Healthy Minds Program App

Hydro Coach active control group (HC)

Active Comparator group

Description:

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.

Treatment:

Other: Hydro Coach App