COVID-19 and the Healthy Minds Program for Educators

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
COVID-19 and the Healthy Minds Program for Educators

Conditions
-----------------
Anxiety, Depression, Psychological Stress, Psychological Distress, Well-being

Intervention / Treatment
-----------------
* Behavioral: Healthy Minds Program Foundations Training


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Minds Program Foundations Training<br>Healthy Minds Program (HMP) Description: The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Richard Davidson, PhD. 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. | Behavioral: Healthy Minds Program Foundations Training<br>* 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.<br>* Other names: mindfulness;|
| No Intervention: Wait-list control<br>Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | 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. | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) | 
| Change From Baseline on the Drexel Defusion Scale (DDS) | 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. | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) | 
| Change From Baseline on the Meaning in Life Questionnaire | 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. | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) | 
| Change From Baseline on the NIH Toolbox Loneliness Scale | 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. | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) | 
| Conway COVID Questionnaire Subscale Scores | 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. | baseline | 
| Conway COVID Questionnaire Subscale Scores | 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. | 4 weeks (post intervention) | 
| Conway COVID Questionnaire Subscale Scores | 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. | 16 weeks (3 months post-intervention) | 
| Self-Compassion Scale Short Form Score | 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. | baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention) | 
| Change From Baseline on the Perseverative Thought Questionnaire | 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. | baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention) | 
| Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale | 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. | baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention) | 
| Change From Baseline on the Neutral Face Rating Task | 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 both prosocial construal and bias range from 1 to 7, with higher scores representing greater prosocial construal and bias favoring white faces (negative scores on the bias measure indicate bias for liking black faces more than white faces). | baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention) | 
| Change From Baseline on the Growth Mindset Scale for Well-Being | 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). | baseline, 4 weeks (post intervention) |