DepressionNCT06626425
Well-being Training for Adolescent Depressive Symptoms (TeenWell Study)
A study testing Healthy Minds Program App and Hydro Coach App in people with Depression, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Depression
- What is being tested?
- Healthy Minds Program App and Hydro Coach App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Has received a high school diploma or a high school equivalency diploma (HSED or GED)
- Weekly or more frequent meditation practice
- Prior use of the Healthy Minds Program app
- Prior use of the water tracking app
- Endorses current active suicidal ideation with intent on the baseline screen
- Self-reported history of psychosis or mania
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Healthy Minds, University of Wisconsin Madison
Madison, Wisconsin, 53705
Roxanne Hoks Research Program Manager, BA, 608-265-2596, rmmonticelli@wisc.edu
About this study
Official title: Smartphone-based Meditation Training to Reduce Adolescent Depression
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Healthy Minds Program App, Hydro Coach App
- Keywords
- adolescent, meditation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Minds Program AppOther
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.
Hydro Coach AppOther
The Hydro Coach app (HC). A smartphone-based wellness app to ensure proper hydration.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Minds Program (HMP) App | Experimental | The HMP is a smartphone meditation-based well-being training. Receives: Other: Healthy Minds Program App |
| 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. Receives: Other: Hydro Coach App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks, 20 weeks
Secondary outcomes (15)
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
Measured: 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.
Measured: 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.
Measured: 8 weeks, 20 weeks
Sleep Duration assessed with wearable device
Total sleep time will be measured through the Biostrap device.
Measured: 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.
Measured: Daily through 20 weeks
Wake after sleep onset
The amount of time awake after sleep onset will be assessed with the Biostrap device.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start7 Dec 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized active-controlled wait-list trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Matthew Hirshberg, PhD, Principal investigator, Center for Healthy Minds, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626425
- Sponsor's protocol ID
- 2023-0554
- Other IDs
- 1K01MH130752-01A1, A483000, Protocol Version 5/22/25
- Status last verified
- May 2026
- First submitted
- 1 Oct 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-based Meditation Training to Reduce Adolescent Depression
- ClinicalTrials.gov ID
- NCT06626425
- Acronym / sponsor ID
- 2023-0554
- Conditions
- Depression
- Keywords
- adolescent, meditation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Dec 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized active-controlled wait-list trial
| Arm | Type | Receives |
|---|---|---|
| Healthy Minds Program (HMP) App | Experimental | Other: Healthy Minds Program AppThe HMP is a smartphone meditation-based well-being training. |
| Hydro Coach active control group (HC) | Active comparator | Other: Hydro Coach AppThe 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Has received a high school diploma or a high school equivalency diploma (HSED or GED)
- Weekly or more frequent meditation practice
- Prior use of the Healthy Minds Program app
- Prior use of the water tracking app
- Endorses current active suicidal ideation with intent on the baseline screen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Minds Program AppAn 8-week meditation-based well-being training containing content for each of the four pillars of the training program: Awareness, Connection, Insight, and Purpose. | Other | Healthy Minds Program (HMP) App |
| Hydro Coach AppThe Hydro Coach app (HC). A smartphone-based wellness app to ensure proper hydration. | Other | Hydro Coach active control group (HC) |
Primary outcome
PROMIS Pediatric Depression T-Scores
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.
15 secondary outcomes
PROMIS Pediatric Anxiety T-Scores
Time frame: 8 weeks, 20 weeks
EPOCH Wellbeing Scores
Time frame: 8 weeks, 20 weeks
PROMIS Pediatric Sleep Disturbance T-Score
Time frame: 8 weeks, 20 weeks
Sleep Duration assessed with wearable device
Time frame: Daily through 20 weeks
Sleep Staging assessed with wearable device
Time frame: Daily through 20 weeks
Wake after sleep onset
Time frame: Daily through 20 weeks
Pulse Rate Variability (PRV) collected by a wearable sensor
Time frame: Daily through 20 weeks
Belonging Uncertainty Scale Score
Time frame: 8 weeks, 20 weeks
Drexel Defusion Teen Score
Time frame: 8 weeks, 20 weeks
NIH Toolbox - Emotional Battery Loneliness (Ages 8-17) Fixed Form
Time frame: 8 weeks, 20 weeks
Perseverative Thinking Questionnaire - Child Scores
Time frame: 8 weeks, 20 weeks
Healthy Minds Index
Time frame: 8 weeks
Five Facet Mindfulness Questionnaire 16-item Adolescent version
Time frame: 8 weeks
Attitudes Towards Online Psychological Interventions
Time frame: 8 weeks
Adverse Meditation Experience Questionnaire
Time frame: 8 weeks, 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Hirshberg, PhD principal investigator
Center for Healthy Minds, UW Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Minds Program App and Hydro Coach App in people with Depression, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Hirshberg, PhD ((608) 262-0035, hirshberg@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Pediatric Depression T-Scores (time frame: 8 weeks, 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.