Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K01MH130752-01A1 | U.S. NIH Grant/Contract | View source | |
| A483000 | Other Identifier | UW Madison | |
| Protocol Version 5/22/25 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
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
Secondary Objectives
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Minds Program (HMP) App | Experimental | The HMP is a smartphone meditation-based well-being training. |
|
| Hydro Coach active control group (HC) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Minds Program App | Other | 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. |
| 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 |
| 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 |
| 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 |
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Hirshberg, PhD | Contact | (608) 262-0035 | hirshberg@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Hirshberg, PhD | Center for Healthy Minds, UW Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Healthy Minds, University of Wisconsin Madison | Recruiting | Madison | Wisconsin | 53705 | United States |
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.
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.
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
This is a randomized active-controlled wait-list trial
Not provided
Not provided
Not provided
| Hydro Coach App | Other | The Hydro Coach app (HC). A smartphone-based wellness app to ensure proper hydration. |
|
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 |
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 |