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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
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.
The Hydro Coach app (HC). A smartphone-based wellness app to ensure proper hydration.
Center for Healthy Minds, University of Wisconsin Madison
Madison, Wisconsin, United States
RECRUITINGPROMIS 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.
Time frame: 8 weeks, 20 weeks
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
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks, 20 weeks
Sleep Duration assessed with wearable device
Total sleep time will be measured through the Biostrap device.
Time frame: 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.
Time frame: Daily through 20 weeks
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Wake after sleep onset
The amount of time awake after sleep onset will be assessed with the Biostrap device.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks, 20 weeks