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Depression, AnxietyNCT07278466

The COMParing App Support Strategies Study

A study testing Introductory Coaching Session, Introductory Information Session and On-Demand Email or Text Support in people with Depression, Anxiety, run by University of Wisconsin, Madison at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Depression, Anxiety
What is being tested?
Introductory Coaching Session, Introductory Information Session and On-Demand Email or Text Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
688 participants
Where
1 siteUnited States
Study dates
13 Mar 2026to 31 Jan 2029
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Individuals who do not have their camera turned on and remain visible on camera during the virtual introductory and coaching sessions (if applicable).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wendy Lau, PhD contact

608-890-2747

wendy.lau@wisc.edu

United States1 site, 1 recruiting
  • Center for Healthy Minds

    Madison, Wisconsin, 53703

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Participants will be randomly assigned to various support conditions that vary across three binary factors,

  1. Coaching session vs no coaching
  2. On-demand email support (Yes/No)
  3. Microsupport messages (Yes/No)

Participants will be screened for eligibility using a web-based screener that assesses inclusion and exclusion criteria. Eligible participants will receive a study overview and will have the option to go through an online consent process. After giving consent, participant will receive a text message to assess their ability to receive text messages and tab on a link embedded in the text message. Those who failed to go through this process will be screened out.

Participants consented will complete a baseline survey consisting of a series of questionnaires and daily check-in assessment sent to their phone. Only those who successfully complete the baseline survey and the first daily check-in survey will advance in the study. Participants will schedule a meeting with our study staff member after completing the baseline survey and first daily check-in survey. They will be assessed through questionnaires at baseline, weekly during the 4-week intervention period, and at 6-month follow-up. They will also complete daily check-in survey twice a day throughout the intervention.

Being tested
Introductory Coaching Session, Introductory Information Session, On-Demand Email or Text Support, Microsupport
Keywords
HMP app, healthy minds program, Microsupport, meditation
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Introductory Coaching SessionOther

    Participant is randomized to receive a 30-minute meditation coaching session

  • Introductory Information SessionOther

    Participant is randomized to receive a 30-minute information session

  • On-Demand Email or Text SupportOther

    Also called email, text

    email or text support throughout the 4 week intervention period

  • MicrosupportOther

    Also called text message

    Text message microsupport throughout the 4 week intervention period

Study groups in NCT07278466
Study groupRoleWhat they receive
CoachingExperimentalNot described
Receives: Other: Introductory Coaching Session
Coaching with On-Demand email or text supportExperimentalNot described
Receives: Other: Introductory Coaching Session; Other: On-Demand Email or Text Support
Coaching and microsupportExperimentalNot described
Receives: Other: Introductory Coaching Session; Other: Microsupport
Coaching with On-Demand email or text support and microsupportExperimentalNot described
Receives: Other: Introductory Coaching Session; Other: On-Demand Email or Text Support; Other: Microsupport
No additional supportNo interventionNot described
On-Demand email or text supportExperimentalNot described
Receives: Other: Introductory Information Session; Other: On-Demand Email or Text Support
MicrosupportExperimentalNot described
Receives: Other: Introductory Information Session; Other: Microsupport
On-Demand email or text support and microsupportExperimentalNot described
Receives: Other: Introductory Information Session; Other: On-Demand Email or Text Support; Other: Microsupport

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) Score

    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.

    Measured: baseline, week 1, week 2, week 3, week 4, 6-month follow up

  2. Anxiety Measured from Evening Daily Diary Items

    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.

    Measured: Daily through the Intervention Period (up to 4 weeks)

  3. Depression Measured from Evening Daily Diary Items

    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.

    Measured: Daily through the Intervention Period (up to 4 weeks)

Secondary outcomes (31)
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Depression

    A computer-adaptive measure of feelings of depression scored from 1 to 5 where higher numbers indicate increased feelings of depression. It provides t-scores with a mean of 50 and SD of 10

    Measured: baseline, week 1, week 2, week 3, week 4, 6-month follow up

  2. PROMIS Toolbox Meaning and Purpose Score

    The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life's meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life.

    Measured: baseline, week 1, week 2, week 3, week 4, 6-month follow up

  3. NIH Toolbox Loneliness Score

    The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness.

    Measured: baseline, week 1, week 2, week 3, week 4, 6-month follow up

  4. Beck's Depression Inventory (BDI) Item 9 Score

    Item 9 on the Beck Depression Inventory (BDI) assesses suicidal thoughts or wishes. The possible scores for this item are 0, 1, 2, or 3, corresponding to different levels of severity. A score of 0 indicates no suicidal thoughts, while higher scores indicate increasing severity of suicidal ideation.

    Measured: baseline, week 1, week 2, week 3, week 4, 6-month follow up

  5. Five Facet Mindfulness Questionnaire (Awareness subscale) Score

    The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is an 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus.

    Measured: baseline, week 1, week 2, week 3, week 4, 6-month follow up

  6. Experiences Questionnaire Decentering subscale Score

    The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience.

    Measured: baseline, week 1, week 2, week 3, week 4, 6-month follow up

  7. Healthy Minds Index (HM Index) - Awareness Score

    The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Awareness subscale is 0 to 16 where higher scores indicate more awareness.

    Measured: baseline, week 4, 6-month follow up

  8. Healthy Minds Index (HM Index) - Connection Score

    The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Connection subscale range from 0 to 24, where higher scores indicate more connection.

    Measured: baseline, week 4, 6-month follow up

  9. Healthy Minds Index (HM Index) - Insight Score

    The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Insight subscale range from 0 to 12, where higher scores indicate more insight.

    Measured: baseline, week 4, 6-month follow up

  10. Healthy Minds Index (HM Index) - Purpose Score

    The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Purpose subscale range from 0 to 16, where higher scores indicate more purpose.

    Measured: baseline, week 4, 6-month follow up

  11. Growth Mindset Scale Adapted for Well-being Score

    The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., "Your well-being is something about you that you can't change very much."). It is scored on a 6-point Likert scale where 1 is "strongly disagree" to 6 being "strongly agree." Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset.

    Measured: baseline, week 4, 6-month follow up

  12. Digital Working Alliance Inventory (DWAI) Score

    DWAI is a six-item questionnaire designed to assess the working alliance within the Healthy Minds Program (HMP) app. It measures the user's connection and agreement with the app, focusing on the bond, tasks, and goals of the therapeutic relationship. It is scored on a 7-point Likert scale, with scores ranging from 6-42. Higher scores indicate a stronger working alliance with the HMP app.

    Measured: week 1, week 2, week 3, week 4

  13. Morning Daily Diary Items

    Morning daily diary will include single-item measures of mindfulness, decentering, connection, purpose, depression, anxiety, happiness, energy, stress, busyness, rumination (2 items), sleep quality, motivation to practice meditation, and expectations and challenges related to using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate greater levels of the respective construct, such as higher mindfulness, greater decentering, stronger sense of purpose, greater happiness, more severe depression or anxiety, better sleep quality, or greater motivation and perceived helpfulness or frustration with HMP use that morning. Daily means with and standard deviations will be reported.

    Measured: Daily through the Intervention Period (up to 4 weeks)

  14. Evening Daily Diary Items

    Evening daily diary will include single-item measures of mindfulness, decentering, connection, purpose, depression, anxiety, happiness, energy, happy event, stress exposure, rumination (2 items), and expectations related to using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate greater levels of the respective construct, such as higher mindfulness, greater decentering, stronger sense of purpose, more severe depression or anxiety, happy event and stressor exposure experience, or greater motivation and perceived helpfulness with HMP use that day. Daily means with and standard deviations will be reported.

    Measured: Daily through the Intervention Period (up to 4 weeks)

  15. Percentage of participants with a formal practice

    Participants' engagement in formal mindfulness practice will be assessed twice a day with a binary yes/no response. Formal practice is defined as using the HMP app.

    Measured: Daily through the Intervention Period (up to 4 weeks)

  16. Percentage of participants with an informal practice

    Participants' engagement in informal mindfulness practice will be assessed twice a day with a 5-point Likert scale (1 = not at all, 5 = all day long). Informal practice is defined as applying well-being practices in daily life.

    Measured: Daily through the Intervention Period (up to 4 weeks)

  17. Percentage of participants who received a text message and applied a well-being strategy

    Participants will indicate whether they received a text message from the study that day (yes/no). If they respond "yes," they will then report whether the message encouraged them to apply a wellbeing strategy (yes/no) and rate the extent to which they applied the strategy in their day-to-day activities on a 5-point Likert scale (1 = not at all, 5 = very much).

    Measured: Daily through the Intervention Period (up to 4 weeks)

  18. Extent to which participants applied a well-being strategy in their day-to-day activities

    Participants who received a text message and applied a well-being strategy will be asked to rate the extent to which they applied the strategy in their day-to-day activities on a 5-point Likert scale (1 = not at all, 5 = very much).

    Measured: Daily through the Intervention Period (up to 4 weeks)

  19. Change in PROMIS Anxiety Score

    The PROMIS Anxiety Score is a computer adaptive measure of feelings of anxiety in the past 7 days. This is a computer-adaptive survey scored on a 5-point Likert scale from 1 (never) to 5 (always) with higher scores indicating increased anxiety. It provides t-scores with a mean of 50 and SD of 10. Higher t-scores indicate higher levels of anxiety.

    Measured: baseline, week 1, week 2, week 3, week 4, 6-month follow up

  20. Medication and Therapy Questionnaire

    The 3-item Medication and Therapy Questionnaire collects information on whether participants received medication or therapy for mental health concerns in the past month. Each item is a yes/no question.

    Measured: baseline, week 4, 6-month follow up

  21. Change in WHODAS 2.0

    WHODAS 2.0 is a 12-item measure which evaluates healthy-related disability in the past 30 days across 6 domains (cognition, mobility, self-care, getting along, life activities, and participation). It is scored on a 5-point Likert scale were 0 = None and 4 = Extreme or cannot do. The total score ranges from 0 to 48 with higher scores indicating higher level of impairment.

    Measured: baseline, week 4, 6-month follow up

  22. Change in the Positive & Negative Affect Schedule (PANAS-SF)

    PANAS is a 10-item measure assessing positive (5 items) and negative (5 items) emotions using a 5-point Likert scale, in which 1 = Never and 5 = Always. The total score of each scale ranges from 5-25. Positive Affect score means higher levels of enthusiastic, alert, and pleasurable engagement. A higher Negative Affect score indicates higher level of distress, nervousness, or anger.

    Measured: baseline, week 4, 6-month follow up

  23. Change in Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)

    AUDIT-C is a 3-item brief alcohol screen using a 5-point Likert scale. The possible range of score is 0-12. Higher scores suggest more hazardous alcohol use or active alcohol use disorders.

    Measured: baseline, week 4, 6-month follow up

  24. HMP Engagement Measure

    HMP engagement is a 16-item measure which assess participant's usage experience with the Healthy Minds Program. It is scored on a 5-point Likert scale where 1 = Strongly disagree to 5 = Strongly agree. The total possible range of scores is 0-80 where higher scores indicate more positive engagement with the app.

    Measured: week 4, 6-month follow up

  25. Change in Adapted Client Service Receipt Inventory (CSRI)

    The adapted CSRI includes five items assessing the number of primary care visits, mental health outpatient visits, emergency or urgent care visits, hospital nights, and mental health or sleep medications used during a 12-week recall period. Responses are recorded as numeric counts ranging from zero to no fixed upper limit, with higher values indicating greater healthcare service use and higher associated healthcare costs.

    Measured: baseline, 6-month follow up

  26. Change in Work Productivity and Activity Impairment (WPA)

    The WPAI is a 6-item questionnaire assessing health-related absenteeism, presenteeism, and activity impairment. Scores are calculated as percentages with higher values indicating greater impairment and lower productivity.

    Measured: baseline, week 4, 6-month follow up

  27. Change in Flourishing Index score

    The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing.

    Measured: baseline, week 1, week 2, week 3, week 4, 6-month follow up

  28. PROMIS Sleep Disturbance

    The PROMIS Sleep Disturbance Score is a measure of sleep in the past 7 days. This is a computer-adaptive survey scored on a 5-point Likert scale with higher scores indicating increased sleep disturbance. It provides t-scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of sleep disturbances.

    Measured: baseline, week 1, week 2, week 3, week 4, 6-month follow up

  29. Supportive Accountability Inventory (SAI)

    The SAI is an 8-item self-report tool to evaluate how users perceive the support and accountability provided by coaches in digital mental health interventions. It uses a 7-point Likert scale (1 = Strongly Disagree; 7 = Strongly Agree). Scores range from 8 to 56. Higher scores indicate a stronger sense of supportive accountability from their coach perceived.

    Measured: week 4, 6-month follow up

  30. Ruminative Response Scale - Brooding subscale score

    The RRS-Brooding subscale is a 5-item, 4-point measure of rumination. Each item indicates the frequency of each event by rating a four-point Likert scale ranging from 1 (Almost never) to 4 (Almost always). The total score ranges from 5-20, with higher scores indicating increased tendency to ruminate.

    Measured: baseline, week 4, 6-month follow up

  31. Treatment Expectancy Measure

    This measure assesses how much the participant believes that the training program was helpful to them. This has two aspects to it: (1) what the participant thought would happen and (2) what the participant feels will happen. Each scale is scored from 1-9 with higher scores indicating better treatment expectancy.

    Measured: week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start13 Mar 2026
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

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
Masking
None (open label)
Enrolment
688 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07278466
Sponsor's protocol ID
2025-1444
Other IDs
1R01MH139512-01, Protocol Version 10/20/2026, EDUC/COUNSELING PSYCH
Status last verified
Sep 2026
First submitted
2 Dec 2025
Last updated
29 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Introductory Coaching Session, Introductory Information Session and On-Demand Email or Text Support in people with Depression, Anxiety, 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 4 inclusion and 6 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 29 Oct 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 Wendy Lau, PhD (608-890-2747, wendy.lau@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. 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 29 Oct 2026.

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