Skip to main content
OpenTrials
Completed

NCT Number: NCT04426318

COVID-19 and the Healthy Minds Program for Educators

This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. A 3-month follow-up in the fall of 2020 will also be conducted.

Participants will be recruited via email and mailed postcards, and will first complete an online screen. Eligible participants will then enter a waiting zone for between 2-days and 2-weeks before they are sent the online pre-test. Upon completion of the pre-test, participants will be assigned to condition via a simple random number generator. If assigned to the intervention (i.e., the Healthy Minds Program App), participants will receive instructions and support in downloading and activating the app. Every 7-days over the 4-week intervention period participants in both conditions will complete the same set of measures. A full battery of measures will be administered a second time post-test, following the 4-week intervention period. Three-months after post-test, a follow-up assessment will be conducted.

The investigators predict that participants assigned to the intervention will demonstrate significantly reduced psychological distress after the intervention, and these decreases will persist at the 3-month follow-up. Further, it is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Psychological Distress Psychological Stress Stress, Psychological Well-Being

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: Yes

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

Inclusion criteria

  • Ages 18 years old and up
  • Employees of a K-12 school district in Wisconsin
  • Smartphone or device that can download apps from Google Play or the iTunes app store

Exclusion criteria

  • Individuals under 18 years old
  • Significant meditation experience:
  • Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component),
  • Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months; or
  • Previous use of the HMP app.
  • Patient-Reported Outcomes Measurement Information System (PROMIS) depression score > 70

Treatment and study plan

Healthy Minds Program Foundations Training

Behavioral

The HMP is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. The program is unique in several ways. First, all program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). Second, in addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.

Other names: meditation, mindfulness

Primary outcomes

  1. Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale

    Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

    Psychological distress will be assessed by aggregating 3 measures: PROMIS anxiety and PROMIS depression, and the NIH Toolbox Perceived Stress Scale. Averages will be z-scored with a mean of 0 and a standard deviation 1. Higher scores indicate increased psychological distress.

Secondary outcomes

  1. Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale

    Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

    A measure of acting with mindful awareness. The total possible range in scores is 8-40, with higher scores indicating greater levels of this facet of mindfulness.

  2. Change From Baseline on the Drexel Defusion Scale (DDS)

    Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

    Psychological distancing (i.e., defusion) will be assessed with the 10-item Drexel Defusion Scale (DDS). The total possible range in scores is 0-50, with higher scores indicating greater levels of psychological distancing.

  3. Change From Baseline on the Meaning in Life Questionnaire

    Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

    The Meaning in Life Questionnaire Presence subscale will be used to measure perceptions of meaning and purpose in life. The total possible range in scores is 5 - 35 with higher scores indicating greater levels of meaning.

  4. Change From Baseline on the NIH Toolbox Loneliness Scale

    Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

    A measure of loneliness (i.e, lack of social connectedness). The total possible range in scores is 1-5, representing the average across all items; higher scores indicate greater levels of loneliness.

  5. Conway COVID Questionnaire Subscale Scores

    Time frame: baseline

    The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.

  6. Conway COVID Questionnaire Subscale Scores

    Time frame: 4 weeks (post intervention)

    The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.

  7. Conway COVID Questionnaire Subscale Scores

    Time frame: 16 weeks (3 months post-intervention)

    The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.

  8. Self-Compassion Scale Short Form Score

    Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

    The Self-Compassion Scale Short Form will be used to measure self-compassion. The total possible range in scores is 12-60, with higher scores indicating greater levels of self-compassion.

  9. Change From Baseline on the Perseverative Thought Questionnaire

    Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

    Negative ruminative thinking will be measured with the Perseverative Thought Questionnaire. The total possible range in scores is 0-60, with higher scores indicating greater levels negative ruminative thinking.

  10. Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale

    Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

    Well-being will be measured using the WHO-5. The total possible range in scores is 0-25, with higher scores indicating greater levels of well-being.

  11. Change From Baseline on the Neutral Face Rating Task: Prosocial Construal

    Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

    The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for prosocial construal is from 1 to 7, with higher scores representing greater prosocial construal.

  12. Change From Baseline on the Neutral Face Rating Task: Race Bias

    Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)

    The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for race bias range from -6 to 6, with higher scores representing greater bias favoring white faces (negative scores on the bias measure indicate bias for liking black faces more than white faces).

  13. Change From Baseline on the Growth Mindset Scale for Well-Being

    Time frame: baseline, 4 weeks (post intervention)

    A measure of fixed versus incremental mindset regarding well-being. The average across items for a possible range in scores from 1-6 will be measured, with higher scores indicating greater levels of incremental views on well-being (i.e., it can be learned).

Other outcomes

  1. Slope Across Time on Practice Quality and Mood Items

    Time frame: Every other day when participant completes a practice (up to 4 weeks)

    4-tems following each app-based practice for treatment participants that ask about perceive quality of the practice, (1 poor, 9 very good), and mood (1 poor, 5 good).

  2. Digital Working Alliance

    Time frame: After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only

    A measure of working alliance in a digital environment that will be averaged across all items for a score range from 1 to 7, with higher scores reflecting higher levels of alliance.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Center for Healthy Minds
  • Chan Zuckerberg Initiative
  • Healthy Minds Innovations

Registry information

Acronym: CAHMP-ED

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Sep 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.