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

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Other: Healthy Minds Program App; Other: Hydro Coach App

• Registration Number: NCT06626425
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Study Start: 2024-12-07
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-07
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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 suicidal thoughts on the baseline screen
6. Self-reported history of psychosis or mania
7. Currently receiving, history of receiving in the last 6 months, or planning to start any of the following types of therapy within the next 5 months: Acceptance Commitment Therapy (ACT), Dialectical Behavior Therapy (DBT), and other mindfulness-based therapies (e.g., Mindfulness-Based Cognitive Therapy). For history of receiving only, only excluded if the participants has used the techniques on a weekly more frequent basis in the last 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Minds Program (HMP) App	Healthy Minds Program App	The HMP is a smartphone meditation-based well-being training.
Hydro Coach active control group (HC)	Hydro Coach App	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.

Primary Outcome Measures

Name	Time	Method
PROMIS Pediatric Depression T-Scores	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 Outcome Measures

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

Trial Locations

Locations (1)

Center for Healthy Minds, University of Wisconsin Madison; 🇺🇸 Madison, Wisconsin, United States