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OpenTrials
Completed

NCT Number: NCT06282523

Healthy Minds Comparison Study

The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being.

Participants will complete an online four-week well-being program and complete surveys sent to their email. Participants can expect to participate in the study for four months.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • Elevated symptoms of depression and anxiety
  • Proficient in English
  • Access to a smartphone

Exclusion criteria

  • Prior experience with meditation generally
  • Prior use of the Healthy Minds application
  • History of psychosis or mania
  • Alcohol and/or substance use disorder

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.

HMRP web app

Behavioral

The HMRP web app is a meditation-based web-based 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. HMRP provides core content, with instruction administered through a curriculum of guided practices. HMRP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

Primary outcomes

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

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    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.

Secondary outcomes

  1. HMP App Utilization: Days

    Time frame: Study duration (4 weeks)

    Number of days the app was accessed.

  2. HMP App Utilization: Number of Activities

    Time frame: Study duration (4 weeks)

    Number of activities completed

  3. HMP App Utilization: Minutes

    Time frame: Study duration (4 weeks)

    Minutes of meditation practice completed

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

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    The HM Index assesses qualities trained in the HMP and HMRP 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.

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

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    The HM Index assesses qualities trained in the HMP and HMRP 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.

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

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    The HM Index assesses qualities trained in the HMP and HMRP 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.

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

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    The HM Index assesses qualities trained in the HMP and HMRP 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.

  8. Change in Subjective Happiness Scale

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    The SHS is a 4-item scale of global subjective happiness. It is scored on a 1- to 7-point Likert scale where 1 = less happy and 7 = more happy. Mean scores are reported for a range from 4 to 28 where higher scores indicate more happiness.

  9. Change in Satisfaction with Life Scale (SWLS)

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    The SWLS is a 5-item scale of subjective satisfaction with life. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Mean scores are reported for a range from 5 to 35 where higher scores indicate greater satisfaction.

  10. Change in Perceived Stress Scale (PSS-10)

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    The PSS-10 is a 10-item scale assessing perceived stress. It is scored on a 0- to 4-point Likert scale where 0 = never and 4 = very often. Mean scores are reported for a range from 0 to 40 where higher scores indicate greater stress.

  11. Change in Flourishing Measure

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    This is a 12-item questionnaire used to assess various domains of flourishing, or human well-being. It is scored on a 0- to 10-point Likert scale where 0 = poor and 10 = excellent. Mean scores are reported for a range from 0 to 120 where higher scores indicate greater human well-being.

  12. Change in Digital Working Alliance Inventory (DWAI)

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    The DWAI is a 6-item questionnaire assessing participants' alliance with the HMP and HMRP 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.

  13. Change in Experiences Questionnaire (EQ) Decentering Subscale

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    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.

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

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    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.

  15. Change in NIH Toolbox Loneliness

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    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.

  16. Change in Wellbeing Growth Mindset

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    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).

  17. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose

    Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months

    PROMIS Meaning and Purpose is a 37-item questionnaire assessing sense of meaning and purpose. It is scored on a 1- to 5-point Likert scale where 1 = not at all and 5 = very much. Mean scores are reported for a range from 37 to 185 where higher scores indicate greater sense of meaning and purpose.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
Jan 15, 2025

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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