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Recruiting NCT06626425

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

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healthy Minds Program App, Hydro Coach App.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: 14 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Smartphone-based Meditation Training to Reduce Adolescent Depression

Overview

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

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.

Interventions

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

Primary outcome measures

  • PROMIS Pediatric Depression T-Scores [Time frame: 8 weeks, 20 weeks]
Secondary outcome measures (12)
  • PROMIS Pediatric Anxiety T-Scores [Time frame: 8 weeks, 20 weeks]
  • EPOCH Wellbeing Scores [Time frame: 8 weeks, 20 weeks]
  • PROMIS Pediatric Sleep Disturbance T-Score [Time frame: 8 weeks, 20 weeks]
  • Sleep Duration assessed with wearable device [Time frame: Daily through 20 weeks]
  • Sleep Staging assessed with wearable device [Time frame: Daily through 20 weeks]
  • Wake after sleep onset [Time frame: Daily through 20 weeks]
  • Pulse Rate Variability (PRV) collected by a wearable sensor [Time frame: Daily through 20 weeks]
  • Belonging Uncertainty Scale Score [Time frame: 8 weeks, 20 weeks]
  • Drexel Defusion Teen Score [Time frame: 8 weeks, 20 weeks]
  • NIH Toolbox - Emotional Battery Loneliness (Ages 8-17) Fixed Form [Time frame: 8 weeks, 20 weeks]
  • Perseverative Thinking Questionnaire - Child Scores [Time frame: 8 weeks, 20 weeks]
  • Healthy Minds Index [Time frame: 8 weeks]

Eligibility criteria

  • Age 14 to 19
  • Currently in high school (i.e., 9th to 12th grade) or if not attending school, would be in high school if enrolled
  • Proficient in English
  • 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)
  • PROMIS Depression Scale T-score greater than or equal to 60
  • If on a psychotropic meditation, has been receiving a stable dose for greater than or equal to 4 weeks
  • Willing and able to complete all study procedures

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Center for Healthy Minds, University of Wisconsin Madison — Madison

Identifiers

NCT: NCT06626425 · 2023-0554 · 1K01MH130752-01A1 · A483000 · Protocol Version 5/22/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗