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Completed

NCT Number: NCT05229406

Healthy Minds Program App Dosage

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

HMP app

Behavioral

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.

Primary outcomes

  1. 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)

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

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

    Time frame: Baseline to post-test (week 4)

    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.

  3. Percentage of EMA Completed

    Time frame: Baseline to post-test (week 4)

    Percentage of EMA assessments that were completed

  4. Study Completion Rate

    Time frame: Baseline to post-test (week 4)

    Percentage of participants completing pre- and post-test measures

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

    Time frame: Baseline to post-test (week 4)

    Number of participants completing practices ≥50% of days

  6. Modified System Usability Scale (MSUS)

    Time frame: Post-test (week 4)

    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.

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

    Time frame: Baseline, and post-test (week 4)

    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.

  8. HMP App Utilization: Minutes

    Time frame: Baseline to post-test (week 4)

    Minutes of meditation practice completed

  9. HMP App Utilization: Days

    Time frame: Baseline to post-test (week 4)

    Number of days the app was accessed.

  10. HMP App Utilization: Number of Activities

    Time frame: Baseline to post-test (week 4)

Secondary outcomes

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

    Time frame: Baseline, and post-test (week 4)

    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.

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

    Time frame: Baseline, and post-test (week 4)

    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.

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

    Time frame: Baseline, and post-test (week 4)

    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.

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

    Time frame: Baseline, and post-test (week 4)

    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.

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

    Time frame: Baseline, and post-test (week 4)

    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.

  6. Change in Wellbeing Growth Mindset

    Time frame: Baseline, and post-test (week 4)

    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).

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

    Time frame: Baseline, and post-test (week 4)

    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.

  8. Change in NIH Toolbox Loneliness

    Time frame: Baseline, and post-test (week 4)

    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.

  9. Change in Experiences Questionnaire (EQ) Decentering Subscale

    Time frame: Baseline, and post-test (week 4)

    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.

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

    Time frame: Baseline, and post-test (week 4)

    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.

  11. Change in PROMIS Sleep Disturbance

    Time frame: Baseline, and post-test (week 4)

    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.

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

    Time frame: up to 4 weeks

    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.

Other outcomes

  1. Change in EMA-assessed Psychological Distress (Composite of Depression and Anxiety Items)

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item reflecting depression and a single item reflecting anxiety are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.

  2. Change in EMA-assessed Mindfulness of Activities

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item mindfulness of activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.

  3. Change in EMA-assessed Mindfulness of Feelings / Emotions

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item assessing awareness of feelings is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware.

  4. Change in EMA-assessed Loneliness

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item assessing loneliness is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.

  5. Change in EMA-assessed Connection With Others

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item assessing connection with others is scored on a 1- to 5-point Likert scale where 1 = not often at all and 5 = extremely often

  6. Change in EMA-assessed Decentering

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item assessing decentering (i.e., experiencing thoughts more as events than direct reflection of reality) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.

  7. Change in EMA-assessed Insight

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item assessing insight is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware

  8. Change in EMA-assessed Purpose

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item assessing purpose is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much

  9. Change in EMA-assessed Stressor Exposure

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item assessing stressor exposure is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.

  10. Change in EMA-assessed Personal Values / Meaning

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item assessing reflection of personal values in current activity is scored on a 1- to 5-point Likert scale where 1 = not at all reflected and 5 = extremely reflected.

  11. Change in EMA-assessed Rumination

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item assessing rumination is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much

  12. Change in EMA-assessed Informal Practice

    Time frame: 4 times per day from baseline to post-test (week 4)

    A single item assessing application of meditation techniques in daily life (informal practice) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.

  13. Change in Pre- and Post-practice Positive Affect

    Time frame: Before and after meditation practices between baseline and post-test (week 4)

    Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.

  14. Change in Pre- and Post-practice Negative Affect

    Time frame: Before and after meditation practices between baseline and post-test (week 4)

    Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much

  15. Change in Post-practice Focus

    Time frame: Before and after meditation practices between baseline and post-test (week 4)

    A single item assessing focus during meditation is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time

  16. Digital Working Alliance Inventory (DWAI)

    Time frame: Post-test (week 4)

    The DWAI is a 6-item questionnaire assessing participants' alliance with the HMP app. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 6 to 42 where higher scores indicate a stronger working alliance.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Healthy Minds Program (HMP) App Dosage Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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