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.
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.
United States1 site, 1 recruiting
- Recruiting
Center for Healthy Minds
Madison, Wisconsin, 53703
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,
- Coaching session vs no coaching
- On-demand email support (Yes/No)
- 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.
- Conditions
- Depression, Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| Coaching | Experimental | Not described Receives: Other: Introductory Coaching Session |
| Coaching with On-Demand email or text support | Experimental | Not described Receives: Other: Introductory Coaching Session; Other: On-Demand Email or Text Support |
| Coaching and microsupport | Experimental | Not described Receives: Other: Introductory Coaching Session; Other: Microsupport |
| Coaching with On-Demand email or text support and microsupport | Experimental | Not described Receives: Other: Introductory Coaching Session; Other: On-Demand Email or Text Support; Other: Microsupport |
| No additional support | No intervention | Not described |
| On-Demand email or text support | Experimental | Not described Receives: Other: Introductory Information Session; Other: On-Demand Email or Text Support |
| Microsupport | Experimental | Not described Receives: Other: Introductory Information Session; Other: Microsupport |
| On-Demand email or text support and microsupport | Experimental | Not 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.
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
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted12 Dec 2025
- Study start13 Mar 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 688 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
- Simon Goldberg, PhD, Principal investigator, UW Madison
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COMParing App Support Strategies Study
- ClinicalTrials.gov ID
- NCT07278466
- Acronym / sponsor ID
- 2025-1444
- Conditions
- Depression, Anxiety
- Keywords
- HMP app, healthy minds program, Microsupport, meditation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 688 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 12 Dec 2025 (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.
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.
Detailed description
Participants will be randomly assigned to various support conditions that vary across three binary factors,
- Coaching session vs no coaching
- On-demand email support (Yes/No)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Coaching | Experimental | Other: Introductory Coaching Session |
| Coaching with On-Demand email or text support | Experimental | Other: Introductory Coaching Session, Other: On-Demand Email or Text Support |
| Coaching and microsupport | Experimental | Other: Introductory Coaching Session, Other: Microsupport |
| Coaching with On-Demand email or text support and microsupport | Experimental | Other: Introductory Coaching Session, Other: On-Demand Email or Text Support, Other: Microsupport |
| No additional support | No intervention | – |
| On-Demand email or text support | Experimental | Other: Introductory Information Session, Other: On-Demand Email or Text Support |
| Microsupport | Experimental | Other: Introductory Information Session, Other: Microsupport |
| On-Demand email or text support and microsupport | Experimental | Other: Introductory Information Session, Other: On-Demand Email or Text Support, Other: Microsupport |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Introductory Coaching SessionParticipant is randomized to receive a 30-minute meditation coaching session | Other | Coaching, Coaching and microsupport, Coaching with On-Demand email or text support, Coaching with On-Demand email or text support and microsupport |
| Introductory Information SessionParticipant is randomized to receive a 30-minute information session | Other | Microsupport, On-Demand email or text support, On-Demand email or text support and microsupport |
| On-Demand Email or Text SupportAlso: email, textemail or text support throughout the 4 week intervention period | Other | Coaching with On-Demand email or text support, Coaching with On-Demand email or text support and microsupport, On-Demand email or text support, On-Demand email or text support and microsupport |
| MicrosupportAlso: text messageText message microsupport throughout the 4 week intervention period | Other | Coaching and microsupport, Coaching with On-Demand email or text support and microsupport, Microsupport, On-Demand email or text support and microsupport |
Primary outcome
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.
31 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression
Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up
PROMIS Toolbox Meaning and Purpose Score
Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up
NIH Toolbox Loneliness Score
Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up
Beck's Depression Inventory (BDI) Item 9 Score
Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up
Five Facet Mindfulness Questionnaire (Awareness subscale) Score
Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up
Experiences Questionnaire Decentering subscale Score
Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up
Healthy Minds Index (HM Index) - Awareness Score
Time frame: baseline, week 4, 6-month follow up
Healthy Minds Index (HM Index) - Connection Score
Time frame: baseline, week 4, 6-month follow up
Healthy Minds Index (HM Index) - Insight Score
Time frame: baseline, week 4, 6-month follow up
Healthy Minds Index (HM Index) - Purpose Score
Time frame: baseline, week 4, 6-month follow up
Growth Mindset Scale Adapted for Well-being Score
Time frame: baseline, week 4, 6-month follow up
Digital Working Alliance Inventory (DWAI) Score
Time frame: week 1, week 2, week 3, week 4
Morning Daily Diary Items
Time frame: Daily through the Intervention Period (up to 4 weeks)
Evening Daily Diary Items
Time frame: Daily through the Intervention Period (up to 4 weeks)
Percentage of participants with a formal practice
Time frame: Daily through the Intervention Period (up to 4 weeks)
Percentage of participants with an informal practice
Time frame: Daily through the Intervention Period (up to 4 weeks)
Percentage of participants who received a text message and applied a well-being strategy
Time frame: Daily through the Intervention Period (up to 4 weeks)
Extent to which participants applied a well-being strategy in their day-to-day activities
Time frame: Daily through the Intervention Period (up to 4 weeks)
Change in PROMIS Anxiety Score
Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up
Medication and Therapy Questionnaire
Time frame: baseline, week 4, 6-month follow up
Change in WHODAS 2.0
Time frame: baseline, week 4, 6-month follow up
Change in the Positive & Negative Affect Schedule (PANAS-SF)
Time frame: baseline, week 4, 6-month follow up
Change in Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)
Time frame: baseline, week 4, 6-month follow up
HMP Engagement Measure
Time frame: week 4, 6-month follow up
Change in Adapted Client Service Receipt Inventory (CSRI)
Time frame: baseline, 6-month follow up
Change in Work Productivity and Activity Impairment (WPA)
Time frame: baseline, week 4, 6-month follow up
Change in Flourishing Index score
Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up
PROMIS Sleep Disturbance
Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up
Supportive Accountability Inventory (SAI)
Time frame: week 4, 6-month follow up
Ruminative Response Scale - Brooding subscale score
Time frame: baseline, week 4, 6-month follow up
Treatment Expectancy Measure
Time frame: week 4
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 29 Oct 2026.
- Center for Healthy MindsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Simon Goldberg, PhD principal investigator
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 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.