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

Smartphone-based Meditation Training to Reduce Adolescent Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Other: Healthy Minds Program App; Other: Hydro Coach App

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Hirshberg, PhD; Phone Number: (608) 262-0035; Email: hirshberg@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • Center for Healthy Minds, University of Wisconsin Madison
      • Contact: Roxanne Hoks Research Program Manager, BA; Phone Number: 608-265-2596; Email: rmmonticelli@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Minds Program (HMP) App; The HMP is a smartphone meditation-based well-being training.	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.
Active Comparator: 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.	Other: Hydro Coach App; The Hydro Coach app (HC). A smartphone-based wellness app to ensure proper hydration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Pediatric Anxiety T-Scores	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	8 weeks, 20 weeks
EPOCH Wellbeing Scores	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.	8 weeks, 20 weeks
PROMIS Pediatric Sleep Disturbance T-Score	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.	8 weeks, 20 weeks
Sleep Duration assessed with wearable device	Total sleep time will be measured through the Biostrap device.	Daily through 20 weeks
Sleep Staging assessed with wearable device	Proportion of sleep time awake, in REM and non-REM sleep will be measured through the Biostrap device and Philips sleep staging algorithm.	Daily through 20 weeks
Wake after sleep onset	The amount of time awake after sleep onset will be assessed with the Biostrap device.	Daily through 20 weeks
Pulse Rate Variability (PRV) collected by a wearable sensor	Root mean square of successive differences of heart beats and High-Frequency power will be analyzed.	Daily through 20 weeks
Belonging Uncertainty Scale Score	The Belonging Uncertainty Scale is scored from 1-7 where higher scores indicate more uncertainty about belonging.	8 weeks, 20 weeks
Drexel Defusion Teen Score	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.	8 weeks, 20 weeks
NIH Toolbox - Emotional Battery Loneliness (Ages 8-17) Fixed Form	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.	8 weeks, 20 weeks
Perseverative Thinking Questionnaire - Child Scores	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.	8 weeks, 20 weeks
Healthy Minds Index	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	8 weeks
Five Facet Mindfulness Questionnaire 16-item Adolescent version	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.	8 weeks
Attitudes Towards Online Psychological Interventions	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.	8 weeks
Adverse Meditation Experience Questionnaire	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.	8 weeks, 20 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digital Working Alliance Inventory	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.	Weeks 2, 4, 6, 8 and 20.
Growth mindset personality and intelligence	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.	Baseline, week 8 and week 20.
Problematic Internet Use Scale	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.	Baseline, week 8 and week 20
Daily diary of social interactions	A 1 to 6 item end of day experience sampling questionnaire assessing the presence, duration, quality and location of social interactions that day.	Daily through 8 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Matthew Hirshberg, PhD, Center for Healthy Minds, UW Madison

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: adolescent; meditation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: 2023-0554; A483000 (Other Identifier: UW Madison); 1K01MH130752-01A1 (U.S. NIH Grant/Contract); Protocol Version 5/22/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes