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Completed

NCT Number: NCT06244043

Human and Digital Support 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. 32 participants will be enrolled and can expect to be on study for up to 4 weeks.

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Key information

Conditions

Depression Alzheimer Disease Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

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

About this study

The overall purpose of this study is to help determine the feasibility and acceptability of incorporating small amounts of human and digital support into a meditation app. Ultimately, the investigators hope this work will help to develop digital tools that can reduce symptoms of depression and/or anxiety. The meditation app of interest is the Healthy Minds Program (HMP). The HMP app provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.

Participants will be randomly assigned to receive or not receive an initial coaching call with a team member. Participants will also be randomly assigned to receive or not receive access to email-based support. All participants with receive text messages encouraging them to engage in the practices taught in the app.

Participants will complete a set of questionnaires at baseline and post-test (following the 4-week intervention period). Questionnaires and items will be selected from the set of questionnaires included in this application. The average length of time to complete questionnaires will be within 15 to 30 minutes. Participants will also receive short daily surveys.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults (age ≥18) who have recently downloaded the HMP app
  • Elevated symptoms of depression and/or anxiety
  • Patient Health Questionnaire - 9 (PHQ-9) ≥ 5
  • General Anxiety Disorder - 7 (GAD-7) ≥ 5

Exclusion criteria

  • Current suicidal or self-harm ideation (PHQ-9 item 9 > 0)
  • Current or past psychotic disorder
  • Current of past bipolar disorder

Treatment and study plan

Initial Coaching Call

Other

Participant will receive initial coaching call with a team member. This coaching call will either be interventional (i.e., include content intended to prompt their adherence and benefit from the HMP app) or informational (i.e., include content intended to control for the time and attention of attending a coaching session, but not intended to provide specific benefits).

Email Support

Other

Email-based support throughout study period

Text messages

Other

All participants with receive text messages encouraging them to engage in the practices taught in the app.

Primary outcomes

  1. Study completion rate

    Time frame: Baseline to 4 weeks (post-intervention)

    Percentage of participants completing pre- and post-test measures

  2. Daily diary completion rate

    Time frame: Baseline to 4 weeks (post-intervention)

    Percentage of daily assessments completed

  3. Acceptability of Intervention Score

    Time frame: 4 weeks (post-intervention)

    12-item survey scored from 1 - 5 where higher scores indicate more acceptability.

  4. Modified System Usability Scale Score

    Time frame: 4 weeks (post-intervention)

    10-item survey scored from 1-5 where higher scores indicate more usability.

Other outcomes

  1. Attitudes Towards Psychological Online Interventions Score

    Time frame: 4 weeks (post-intervention)

    16-item survey scored from 1 - 5 where higher scores indicate more positive attitude in each of 4 domains: skepticism, confidence, threat, anonymity.

  2. Determinants of Meditation Practice Inventory Score

    Time frame: baseline (pre-intervention)

    12-item survey scored from 1 - 5 where lower scores indicate lower perceived barriers to meditation practice in each of 4 domains; benefit, knowledge, pragmatic, cultural.

  3. Patient Health Questionnaire - 9 (PHQ-9) Score

    Time frame: baseline (pre-intervention), 4 weeks (post-intervention)

    9-item survey scored from 0-27 where higher scores indicate increased depression.

  4. PROMIS Meaning and Purpose Score

    Time frame: baseline (pre-intervention), 4 weeks (post-intervention)

    Computer adaptive survey scored from 1-5 where higher scores indicate higher sense of meaning and purpose.

  5. Digital Working Alliance Inventory (D-WAI) Score

    Time frame: 4 weeks (post-intervention)

    6-item survey scored from 1-7 where higher scores indicate increased trust in the app in each of three domains: goals, tasks, bond.

  6. Five Facet Mindfulness Questionnaire (FFMQ): Awareness Score

    Time frame: baseline (pre-intervention), 4 weeks (post-intervention)

    8-item survey scored from 1-5 where higher scores indicate lower levels of awareness.

  7. General Anxiety Disorder -7 (GAD-7) Score

    Time frame: screening, 4 weeks (post-intervention)

    7-item survey scored from 0-21 where higher scores indicate increased anxiety.

  8. Mindfulness Adherence Questionnaire: Minutes of meditation per week

    Time frame: 4 weeks (post-intervention)

    Minutes of meditation practice completed per week

  9. Mindfulness Adherence Questionnaire Score

    Time frame: 4 weeks (post-intervention)

    10-item survey scored from 0-6 where higher scores indicate higher quality meditation practice in two domains: formal practice, informal practice.

  10. Healthy Minds Index Score

    Time frame: baseline (pre-intervention), 4 weeks (post-intervention)

    17-item survey scored from 0-4 where higher scores indicate healthier attitude in each of 4 domains: awareness, connection, insight, purpose.

  11. NIH Toolbox: Loneliness Score

    Time frame: baseline (pre-intervention), 4 weeks (post-intervention)

    5-item survey scored from 1-5 where higher scores indicate increased loneliness.

  12. Growth Mindset Scale for Well-Being Score

    Time frame: baseline (pre-intervention), 4 weeks (post-intervention)

    3-item survey scored from 1-6 where higher score lower growth mindset.

  13. Experiences Questionnaire Decentering Score

    Time frame: baseline (pre-intervention), 4 weeks (post-intervention)

    11-item survey scored from 1-5 where higher scores indicate higher levels of decentering.

  14. Daily Diary Assessment Question Scores

    Time frame: daily from baseline to post-test (week 4)

    9-items administered in the morning scored from 1 (not at all) to 5 (very much) for domain: mindfulness, decentering, connection, purpose, depression, anxiety, stress, rumination, motivation.

    11-items administered in the evening scored from 1 (not at all) to 5 (very much) for domain: mindfulness, decentering, connection, purpose, depression, anxiety, happy event, stressor exposure item, rumination, informal practice item, formal practice item.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Thrive Foundation

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2024
Registry last updated
Aug 19, 2024

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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