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Completed

NCT Number: NCT04741529

Massed and Spaced HMP App Dosage Study

This study is a randomized controlled trial (RCT) of 2 weeks of the Healthy Minds Program (HMP) app Connection module in undergraduate students of a large, midwestern state university in the United States during the spring of 2021.

Participants will be recruited via email and/or flyers and will first complete an online screen. Eligible participants will complete baseline measures prior to attending an introductory session via web conferencing. During this session, participants will be randomly assigned to condition. Participants in both conditions will be asked to use the HMP app for 20 minutes per either, either split over two 10-minute session (Spaced condition) or in one 20-minute session (Massed condition). Participants will complete daily survey measures during the study and post-test measures after 2 weeks of intervention.

This study is primarily designed to assess feasibility and acceptability of 2 weeks of Connection training and assignment to dosage condition. Study team will investigate self-reported informal practice on the daily diary measure, measures of psychological distress (composite of depression, anxiety) and loneliness.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Loneliness Mental Disorders Psychological Distress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Undergraduate at UW-Madison
  • Access to a smartphone or device capable of downloading HMP app
  • PROMIS Depression or PROMIS Anxiety ≥55

Exclusion criteria

  • Meditation retreat experience
  • Regular meditation practice (i.e., weekly practice for >1 year OR daily practice within previous 6 months)
  • Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
  • PROMIS Depression ≥70

Treatment and study plan

Healthy Minds Program app

Behavioral

The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Drs. Richard Davidson and Cortland Dahl. HMP is 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 high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

Participants in this study will receive 2 weeks of training in the Connection module of HMP.

Primary outcomes

  1. Percentage of participants who completed the study

    Time frame: 2 weeks

  2. Number of meditation sessions per day using the HMP app

    Time frame: 2 weeks

  3. Number of minutes of meditation practice using the HMP app

    Time frame: 2 weeks

  4. System Usability Scale score

    Time frame: 2 weeks

    System usability scale is (SUS) is a 10-item Likert scale questionnaire that provides information on the ease of use (or lack thereof) of websites, software, hardware, mobile devices, and other technological applications. Higher SUS score correlates to better usability of an app, total score range = 0 to 100

Secondary outcomes

  1. Change in the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression score

    Time frame: Baseline and 2 weeks

    Psychological distress computed as composite of 4-item PROMIS Depression measures. Scores range from 4 to 20 with higher scores representing worse symptoms.

  2. Change in the PROMIS Anxiety score

    Time frame: Baseline and 2 weeks

    Psychological distress computed as composite of 4-item PROMIS Anxiety measures. Scores range from 4 to 20 with higher scores representing worse symptoms.

  3. Change in NIH Toolbox Loneliness score

    Time frame: Baseline and 2 weeks

    NIH toolbox loneliness measures the perceptions that one is alone, lonely, or socially isolated from others. It is a 5-item scale. Total score range = 5 to 25, lower score is better

  4. Change in Self-Compassion Short Form score

    Time frame: Baseline and 2 weeks

    This 12-item measure assesses participant's self-compassion ability, total score range = 12 to 60, higher scores correlate to more self-compassion.

  5. Change in Fear of Missing Out scale score

    Time frame: Baseline and 2 weeks

    Fear of missing out is a 10 item scale. Total score range = 10 to 50, lower score is better

  6. Change in Acceptance and Action Questionnaire - II score

    Time frame: Baseline and 2 weeks

    Acceptance and Action Questionnaire- II measures psychological flexibility Experiential avoidance, total score range = 7 to 49. Higher total scores mean less flexibility, while lower total scores mean more flexibility. Lower score is better.

  7. Single item loneliness score

    Time frame: Up to 2 weeks

    "How lonely did you feel today?", range = 1 to 7, lower score is better

  8. Highest loading PROMIS Depression and PROMIS Anxiety items score

    Time frame: Up to 2 weeks

    Composite of highest loading PROMIS items modified to reference "today," z-transformed to have mean of 0 and standard deviation of 1, lower score is better.

  9. Single item informal meditation practice

    Time frame: Up to 2 weeks

    Single item informal meditation practice measure, "As you reflect on today, to what extent did you apply these practices?" Scores range from 0 to 100. A higher score is better.

  10. Digital Working Alliance Inventory score

    Time frame: 2 weeks

    The Digital Working Alliance Inventory measures the therapeutic relationship between participant and HMP app. Total score range = 6 to 42, higher score is better.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Massed and Spaced Healthy Minds Program App Dosage Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Jun 11, 2021

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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