NCT07278466 · University of Wisconsin, Madison
The COMParing App Support Strategies Study
What this study is about
The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.
View original scientific description
The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.
Interventions
OTHER
Introductory Coaching Session
Participant is randomized to receive a 30-minute meditation coaching session
OTHER
Introductory Information Session
Participant is randomized to receive a 30-minute information session
OTHER
On-Demand Email Support
email support throughout the 4 week intervention period
OTHER
Microsupport
Text message microsupport throughout the 4 week intervention period
Primary outcome measures
Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) Score
Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up
The PHQ-ADS is scored by summing responses to its 16 items (combining the PHQ-9 and GAD-7), with scores ranging from 0 to 48, where higher scores indicate greater distress. Each item uses a 0-3 scale (0=Not at all, 3=Nearly every day). Common interpretation is 10 (mild), 20 (moderate), and 30 (severe) distress.
Anxiety Measured from Evening Daily Diary Items
Time frame: Daily through the Intervention Period (up to 4 weeks)
Evening daily diary will include a single-item measure of anxiety using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate more severe anxiety. Daily means with and standard deviations will be reported.
Depression Measured from Evening Daily Diary Items
Time frame: Daily through the Intervention Period (up to 4 weeks)
Evening daily diary will include a single-item measures of depression using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate more severe depression. Daily means with and standard deviations will be reported.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Elevated symptoms of depression and/or anxiety (PHQ-9 greater than or equal to 10, GAD-7 greater than or equal to 10)
- Proficiency in English
- Access to a smartphone and internet
- Ability to receive text messages
Exclusion criteria
- Non-US citizen or legal resident (green card holder)
- History of psychosis or mania
- Suicidal ideation or thoughts of self-harm indicated by PHQ9 item 9 and BDI item 9
- Individuals who do not provide the information required for GUID generation
- Previous participation
Where
- Madison, Wisconsin
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations