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DepressionPhase 1NCT05229406

Healthy Minds Program App Dosage

A Phase 1 study testing HMP app in people with Depression and Anxiety, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will evaluate the effectiveness of the Healthy Minds Program (HMP) meditation app on participants experiencing depression and/or anxiety. Participants will be assigned to use the HMP app 5- or 15-minutes per day for 4 weeks. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Depression, Anxiety, Psychological Distress
What is being tested?
HMP app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteUnited States
Study dates
21 Feb 2022to 27 Jun 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 or older
  • Access to a smartphone or device capable of downloading HMP app
  • Self-reported willingness to complete 1-2 min survey 4 times per day on phone for 4 weeks
  • Able to speak, read, and write in English
  • PROMIS Depression or PROMIS Anxiety >55

Who cannot join

  • Meditation retreat experience
  • Regular meditation practice (weekly practice for over 1 year OR daily practice within the previous 6 months)
  • Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
  • PROMIS Depression >70
  • AUDIT C score greater than or equal to 4 for men, and greater than or equal to 3 for non-men (any other genders)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin

    Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: Healthy Minds Program (HMP) App Dosage Study

The study will evaluate the effectiveness of the Healthy Minds Program (HMP) meditation app on participants experiencing depression and/or anxiety. Participants will be assigned to use the HMP app 5- or 15-minutes per day for 4 weeks.

Read the detailed description

Depression and anxiety are highly common, but access to evidence-based treatments is limited. Meditation training delivered through mobile health (mHealth) technology may increase access to effective strategies. However, the necessary dosage of meditation practice to produce benefits is unknown. This project will investigate the feasibility, acceptability, and preliminary effectiveness of the HMP app for depression and/or anxiety and the feasibility of randomly assigning participants to practice dosages. Further, the project will provide a preliminary evaluation of the linkages between practice dosage and outcomes assessed retrospectively and in-the-moment via ecological momentary assessment (EMA).

Being tested
HMP app
Keywords
depression, anxiety, behavioral symptoms
Medical subject headings
Depression, Anxiety Disorders, Behavioral Symptoms

What participants receive

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

  • HMP appBehavioural

    The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

Study groups in NCT05229406
Study groupRoleWhat they receive
5-minute app usageExperimentalParticipants will be asked to use the HMP app for 5-minutes per day.
Receives: Behavioral: HMP app
15-minute app usageExperimentalParticipants will be asked to use the HMP app for 15-minutes per day.
Receives: Behavioral: HMP app

What is being measured

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

  1. Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App

    Percentage of those randomized completing ecological momentary assessment (EMA) assessments and activities in the Healthy Minds Program (HMP) app

    Measured: Baseline to post-test (week 4)

  2. Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days

    Number of participants adhering to their assigned dosage greater than or equal to 50 percent of the days. This was assessed directly through the HMP app.

    Measured: Baseline to post-test (week 4)

  3. Percentage of EMA Completed

    Percentage of EMA assessments that were completed

    Measured: Baseline to post-test (week 4)

  4. Study Completion Rate

    Percentage of participants completing pre- and post-test measures

    Measured: Baseline to post-test (week 4)

  5. Number of Participants Completing Practices ≥50% of Days

    Number of participants completing practices ≥50% of days

    Measured: Baseline to post-test (week 4)

  6. Modified System Usability Scale (MSUS)

    The MSUS is a 10-item questionnaire where participants report their experience of the usability of a product, in this case the HMP app. It is scored on a 1- to 5-point Likert scale where 1 = strongly disagree and 5 = strongly agree. The result was rescaled to range from 0 to 100 with higher scores indicate higher usability.

    Measured: Post-test (week 4)

  7. Change in Attitudes Towards Psychological Online Interventions (ATPOI)

    The ATPOI is a 16-item questionnaire where participants report their perception of psychological online interventions. It is scored on a 1- to 5-point Likert scale where 1 = totally disagree and 5 = totally agree. Mean scores are reported for a total possible range of scores is 1 to 5 where higher scores indicate more positive attitudes towards psychological online interventions.

    Measured: Baseline, and post-test (week 4)

  8. HMP App Utilization: Minutes

    Minutes of meditation practice completed

    Measured: Baseline to post-test (week 4)

  9. HMP App Utilization: Days

    Number of days the app was accessed.

    Measured: Baseline to post-test (week 4)

  10. HMP App Utilization: Number of Activities

    Measured: Baseline to post-test (week 4)

Secondary outcomes (12)

  1. Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety

    Psychological distress will be computed as a composite of the PROMIS Depression and PROMIS Anxiety measures. We will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety.

    Measured: Baseline, and post-test (week 4)

  2. Change in Healthy Minds Index (HM Index): Awareness

    The HM Index assesses 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. There are 4 awareness items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more awareness.

    Measured: Baseline, and post-test (week 4)

  3. Change in Healthy Minds Index (HM Index): Connection

    The HM Index assesses 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. There are 6 connection items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more connection.

    Measured: Baseline, and post-test (week 4)

  4. Change in Healthy Minds Index (HM Index): Insight

    The HM Index assesses 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. There are 3 insight items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more insight.

    Measured: Baseline, and post-test (week 4)

  5. Change in Healthy Minds Index (HM Index): Purpose

    The HM Index assesses 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. There are 4 purpose items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more purpose.

    Measured: Baseline, and post-test (week 4)

  6. Change in Wellbeing Growth Mindset

    Well-being Growth Mindset is a 3-item questionnaire assessing participants' perception of the malleability of wellbeing. It is scored on a 1- to 6-point Likert scale where 1 = strongly disagree and 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate more of a growth mindset (i.e., wellbeing is malleable).

    Measured: Baseline, and post-test (week 4)

  7. Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale

    FFMQ Awareness is a 8-item questionnaire assessing mindful awareness. It is scored on a 1- to 5-point Likert scale where 1 = never or very rarely true and 5 = very often or always true. Mean scores are reported with a range from 1 to 5 where higher scores indicate more mindful awareness.

    Measured: Baseline, and post-test (week 4)

  8. Change in NIH Toolbox Loneliness

    NIH Toolbox Loneliness is a 5-item questionnaire assessing loneliness. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = always. Mean scores are reported for a range from 1 to 5 where higher scores indicate more loneliness.

    Measured: Baseline, and post-test (week 4)

  9. Change in Experiences Questionnaire (EQ) Decentering Subscale

    Experiences Questionnaire Decentering is an 11-item questionnaire assessing the psychological capacity of decentering. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = all the time. Mean scores are reported for a total range from 1 to 5 where higher scores indicate more decentering.

    Measured: Baseline, and post-test (week 4)

  10. Change in Meaning in Life Questionnaire (MLQ) Presence Subscale

    MLQ Presence is a 5-item questionnaire assessing the presence of meaning in life. It is scored on a 1- to 7-point Likert scale where 1 = absolutely untrue and 7 = absolutely true. Mean scores are reported for a total range from 1 to 7 where higher scores indicate greater presence of meaning in life.

    Measured: Baseline, and post-test (week 4)

  11. Change in PROMIS Sleep Disturbance

    Sleep disturbance will be assessed using the computer adaptive version of the PROMIS Sleep Disturbance measure. This measure produces scores a T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate greater sleep disturbance.

    Measured: Baseline, and post-test (week 4)

  12. Count of Participant Responses to Adverse Event Relevant Survey Item

    Participants were asked a single survey item to assess their meditation experience. The query was "I had challenging, difficult, or distressing experiences as a result of my meditation during this study." Participants chose from the following responses: Never, Rarely, Occasionally, Regularly, or Frequently. Count of participants in each arm answering each response is reported here.

    Measured: up to 4 weeks

Timeline

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

  1. First posted8 Feb 2022
  2. Study start21 Feb 2022
  3. Primary completion27 Jun 2022
  4. Study completion27 Jun 2022

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to two groups in a 1:1 ratio
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05229406
Sponsor's protocol ID
2019-1578
Other IDs
MSN227550, 2019-1578, A171600, EDUC/COUNSELING PSYCH, 01/21/2022, 1K23AT010879-01
Status last verified
Jul 2023
First submitted
27 Jan 2022
Last updated
1 Aug 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be de-identified and listed in public data registries (e.g., OSF) based on the publication of preregistered study hypotheses on a manuscript by manuscript basis.

Publications

  • Dyer RL, Zimmerman KM, Zhao X, Xie Q, Dahl CJ, Quanbeck A, Goldberg SB. Developing meditation practice in individuals with elevated psychological distress via a meditation app intervention: An implementation science-informed qualitative investigation of barriers and facilitators. Psychol Serv. 2026 Aug;23(3):423-440. doi: 10.1037/ser0000980. Epub 2025 Jul 10.

    PubMed 40638276

  • Xie Q, Dyer RL, Lam SU, Frye C, Dahl CJ, Quanbeck A, Nahum-Shani I, Davidson RJ, Goldberg SB. Understanding the Implementation of Informal Meditation Practice in a Smartphone-Based Intervention: A Qualitative Analysis. Mindfulness (N Y). 2024 Feb;15(2):479-490. doi: 10.1007/s12671-024-02304-x. Epub 2024 Jan 22.

    PubMed 39070019

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HMP app in people with Depression and 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 1 Aug 2023. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App (time frame: Baseline to post-test (week 4)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05229406, which also lists 2 linked publications.

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 1 Aug 2023.

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