Depression
Conditions
Keywords
adolescent, meditation
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.
Interventions
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.
OTHERHydro Coach App
The Hydro Coach app (HC). A smartphone-based wellness app to ensure proper hydration.
Sponsors
University of Wisconsin, Madison
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This is a randomized active-controlled wait-list trial
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTMatthew Hirshberg, PhD
PRINCIPAL_INVESTIGATORMatthew Hirshberg, PhD
Center for Healthy Minds, UW Madison
Outcome results
None listed