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NCT Number: NCT06626425

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

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.

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Key information

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Healthy Minds, University of Wisconsin Madison

Madison, Wisconsin, 53705, United States

Location status: Recruiting

Location contact

Roxanne Hoks Research Program Manager, BA

CONTACT

[email protected]

608-265-2596

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Healthy Minds Program App

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 App

Other

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

Primary outcomes

  1. PROMIS Pediatric Depression T-Scores

    Time frame: 8 weeks, 20 weeks

    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.

Secondary outcomes

  1. PROMIS Pediatric Anxiety T-Scores

    Time frame: 8 weeks, 20 weeks

    T-score less than 55 = None to slight anxiety; between 55.0 and 59.9 = Mild anxiety; between 60.0 and 69.9 = Moderate anxiety; and 70 and over = Severe anxiety

  2. EPOCH Wellbeing Scores

    Time frame: 8 weeks, 20 weeks

    The EPOCH Wellbeing score measures wellbeing in each of 4 domains: engagement, perseverance, optimism, and connectedness. It is scored on a 5 point likert scale from 1 (almost never) to 5 (almost always). Higher scores are indicative of increase wellbeing.

  3. PROMIS Pediatric Sleep Disturbance T-Score

    Time frame: 8 weeks, 20 weeks

    T-score less than 55 = None to slight sleep disturbance; between 55.0 and 59.9 = Mild sleep disturbance; between 60.0 and 69.9 = Moderate sleep disturbance; and 70 and over = Severe sleep disturbance.

  4. Sleep Duration assessed with wearable device

    Time frame: Daily through 20 weeks

    Total sleep time will be measured through the Biostrap device.

  5. Sleep Staging assessed with wearable device

    Time frame: Daily through 20 weeks

    Proportion of sleep time awake, in REM and non-REM sleep will be measured through the Biostrap device and Philips sleep staging algorithm.

  6. Wake after sleep onset

    Time frame: Daily through 20 weeks

    The amount of time awake after sleep onset will be assessed with the Biostrap device.

  7. Pulse Rate Variability (PRV) collected by a wearable sensor

    Time frame: Daily through 20 weeks

    Root mean square of successive differences of heart beats and High-Frequency power will be analyzed.

  8. Belonging Uncertainty Scale Score

    Time frame: 8 weeks, 20 weeks

    The Belonging Uncertainty Scale is scored from 1-7 where higher scores indicate more uncertainty about belonging.

  9. Drexel Defusion Teen Score

    Time frame: 8 weeks, 20 weeks

    Drexel Defusion measures the ability to psychologically distance oneself internal thoughts and feelings. It is scored on a 6-point likert scale from 0 (not at all) to 5 (very much) for a total possible range of scores from 0-50, higher scores indicate increased ability to defuse.

  10. NIH Toolbox - Emotional Battery Loneliness (Ages 8-17) Fixed Form

    Time frame: 8 weeks, 20 weeks

    The NIH Toolbox Loneliness pediatric scale is on a 5 point likert scale from 1 (never) to 5 (always) for a total range of scores from 7-35 where higher scores indicate increased feelings of loneliness.

  11. Perseverative Thinking Questionnaire - Child Scores

    Time frame: 8 weeks, 20 weeks

    The Perseverative Thinking Questionnaire is scored on a 5 point likert scale, from 0 (never) to 4 (almost always) for a total possible range of scores from 0-60 where higher scores indicate increase repetitive negative thinking.

  12. Healthy Minds Index

    Time frame: 8 weeks

    The Healthy Minds Index is a four factor measure of well-being that assesses skills in awareness, connection, insight and purpose. Each item is rated on a 1 (None of the time) to 5 (all of the time) scale, with higher scores representing greater endorsement of the construct. Subscale scores ranges from 4-30

  13. Five Facet Mindfulness Questionnaire 16-item Adolescent version

    Time frame: 8 weeks

    A 16-item self-report that assesses four facets of mindfulness. Items are rated on a 0 (never or rarely true) to 5 (always true) scale, with higher scores representing greater mindfulness. Scores range from 0-80.

  14. Attitudes Towards Online Psychological Interventions

    Time frame: 8 weeks

    A 4-item self-report rated on a 1 (strongly disagree) to 5 (strongly agree) scale that asks participants to report on their attitudes toward digital interventions. Higher scores reflect more positive attitudes. Scores range from 4-20.

  15. Adverse Meditation Experience Questionnaire

    Time frame: 8 weeks, 20 weeks

    An 11-items self-report asking participants to note any difficulties they experience during meditation or attribute to meditation. Responses are coded quantitatively and qualitatively.

Other outcomes

  1. Digital Working Alliance Inventory

    Time frame: Weeks 2, 4, 6, 8 and 20.

    A six-item inventory assessing the degree to which a participant feels alliance with a digital therapeutic. Scores ranges from 6 to 42, with higher scores representing greater alliance.

  2. Growth mindset personality and intelligence

    Time frame: Baseline, week 8 and week 20.

    3-item scales assessing the degree to which a participant feels that their personality and intelligence are innate and unchanging or able to be affected by effort. Items are rated on 1 (Strongly disagree) to 6 (Strongly agree) scale, with higher scores (range 1-6) reflecting greater growth mindset.

  3. Problematic Internet Use Scale

    Time frame: Baseline, week 8 and week 20

    A 3-item self-report inventory that asks participants to rate how often they feel negative effects of their technology use. Items are rated on a never(0) to very often (4) scale, with higher scores representing greater problematic internet use.

  4. Daily diary of social interactions

    Time frame: Daily through 8 weeks

    A 1 to 6 item end of day experience sampling questionnaire assessing the presence, duration, quality and location of social interactions that day.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Hirshberg, PhD

CONTACT

[email protected]

(608) 262-0035

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Smartphone-based Meditation Training to Reduce Adolescent Depression

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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