Center for Healthy Minds, University of Wisconsin Madison
Madison, Wisconsin, 53705, United States
Location status: Recruiting
NCT Number: NCT06626425
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.
Interested in participating?
Request Info14 year–19 year
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53705, United States
Location status: Recruiting
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
Secondary Objectives
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Exclusion criteria
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.
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.
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
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.
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.
Time frame: Daily through 20 weeks
Total sleep time will be measured through the Biostrap 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.
Time frame: Daily through 20 weeks
The amount of time awake after sleep onset will be assessed with the Biostrap device.
Time frame: Daily through 20 weeks
Root mean square of successive differences of heart beats and High-Frequency power will be analyzed.
Time frame: 8 weeks, 20 weeks
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 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
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
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
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
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
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, 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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
Smartphone-based Meditation Training to Reduce Adolescent Depression
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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