Anxiety, Depression, Psychological Distress, Psychological Stress, Well-being
Conditions
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.
Interventions
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.
Sponsors
Chan Zuckerberg Initiative
Healthy Minds Innovations
Center for Healthy Minds
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
There is no outcome assessor - all assessments will be conducted online by participants. Investigators will be blind to group assignment during data analysis. Analysis of hypotheses related to baseline characteristics, adherence and dosage cannot be blinded.
Intervention model description
Random parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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: 1. Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component), 2. Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months; or 3. Previous use of the HMP app. * Patient-Reported Outcomes Measurement Information System (PROMIS) depression score \> 70
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | 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. |
| Change From Baseline on the Drexel Defusion Scale (DDS) | 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. |
| Change From Baseline on the Meaning in Life Questionnaire | 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. |
| Change From Baseline on the NIH Toolbox Loneliness Scale | 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. |
| Conway COVID Questionnaire Subscale Scores | 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. |
| Self-Compassion Scale Short Form Score | 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. |
| Change From Baseline on the Neutral Face Rating Task: Race Bias | 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). |
| Change From Baseline on the Growth Mindset Scale for Well-Being | 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). |
| Change From Baseline on the Perseverative Thought Questionnaire | 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. |
| Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale | 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. |
| Change From Baseline on the Neutral Face Rating Task: Prosocial Construal | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Slope Across Time on Practice Quality and Mood Items | 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). |
| Digital Working Alliance | 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. |
Countries
United States
Participant flow
Pre-assignment details
8321 Wisconsin school system employees invited, 1136 self-screened for eligibility, 353 ineligible (for prior medication, prior HMP app use, or depression t-score greater than 70), 698 consented, 32 did not complete a pre-test, 666 assigned to an arm.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Minds Program Foundations Training Healthy Minds Program (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. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). 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. | 344 |
| Wait-list Control 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. | 318 |
| Total | 662 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | failed attention checks and had their data removed from analyses | 2 | 2 |
Baseline characteristics
| Characteristic | Healthy Minds Program Foundations Training | Total | Wait-list Control |
|---|---|---|---|
| Age, Customized 20-30 years | 55 Participants | 101 Participants | 46 Participants |
| Age, Customized 30-40 years | 105 Participants | 195 Participants | 90 Participants |
| Age, Customized 40-50 years | 103 Participants | 196 Participants | 93 Participants |
| Age, Customized 50-60 years | 61 Participants | 140 Participants | 79 Participants |
| Age, Customized over 60 years | 20 Participants | 29 Participants | 9 Participants |
| Age, Customized under 20 years | 0 Participants | 1 Participants | 1 Participants |
| Employment Category Classroom Support | 47 Participants | 91 Participants | 44 Participants |
| Employment Category Classroom Teacher | 144 Participants | 278 Participants | 134 Participants |
| Employment Category Other / Unknown | 58 Participants | 101 Participants | 43 Participants |
| Employment Category School Administrator | 8 Participants | 12 Participants | 4 Participants |
| Employment Category School Support | 38 Participants | 73 Participants | 35 Participants |
| Employment Category Special Education Teacher | 29 Participants | 60 Participants | 31 Participants |
| Employment Category System Staff | 20 Participants | 47 Participants | 27 Participants |
| Highest Level of Education Advanced Degree | 208 Participants | 386 Participants | 178 Participants |
| Highest Level of Education Graduated College | 100 Participants | 203 Participants | 103 Participants |
| Highest Level of Education Graduated High School | 10 Participants | 16 Participants | 6 Participants |
| Highest Level of Education less than 7 years formal education | 1 Participants | 3 Participants | 2 Participants |
| Highest Level of Education NA | 1 Participants | 3 Participants | 2 Participants |
| Highest Level of Education Some College | 24 Participants | 51 Participants | 27 Participants |
| Household Income $100,000 - $200,000 | 135 Participants | 256 Participants | 121 Participants |
| Household Income $20,000 - $40,000 | 22 Participants | 41 Participants | 19 Participants |
| Household Income $40,000 - $70,000 | 80 Participants | 162 Participants | 82 Participants |
| Household Income $70,000 - $100,000 | 87 Participants | 161 Participants | 74 Participants |
| Household Income greater than $200,000 | 9 Participants | 21 Participants | 12 Participants |
| Household Income Less than $20,000 | 8 Participants | 17 Participants | 9 Participants |
| Household Income Unknown | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian / Alaskan Native | 5 Participants | 9 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian / Pacific Islander | 9 Participants | 13 Participants | 4 Participants |
| Race/Ethnicity, Customized Black / African American | 11 Participants | 26 Participants | 15 Participants |
| Race/Ethnicity, Customized Hispanic / Latino | 15 Participants | 32 Participants | 17 Participants |
| Race/Ethnicity, Customized White / Caucasian | 315 Participants | 602 Participants | 287 Participants |
| Region of Enrollment United States | 344 participants | 662 participants | 318 participants |
| Sex/Gender, Customized Female | 302 Participants | 583 Participants | 281 Participants |
| Sex/Gender, Customized Male | 42 Participants | 79 Participants | 37 Participants |
| Sex/Gender, Customized Non-Binary | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 344 | 0 / 318 |
| other Total, other adverse events | 344 / 344 | 318 / 318 |
| serious Total, serious adverse events | 0 / 344 | 0 / 318 |
Outcome results
Primary
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.
Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | 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 | Baseline | 0.00 z-score | Standard Deviation 0.88 |
| Healthy Minds Program Foundations Training | 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 | Week 1 | -0.29 z-score | Standard Deviation 0.89 |
| Healthy Minds Program Foundations Training | 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 | Week 2 | -0.40 z-score | Standard Deviation 0.85 |
| Healthy Minds Program Foundations Training | 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 | Week 3 | -0.55 z-score | Standard Deviation 0.88 |
| Healthy Minds Program Foundations Training | 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 | Week 4 | -0.67 z-score | Standard Deviation 0.89 |
| Healthy Minds Program Foundations Training | 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 | Week 16 | -0.55 z-score | Standard Deviation 0.87 |
| Wait-list Control | 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 | Week 4 | -0.20 z-score | Standard Deviation 1.03 |
| Wait-list Control | 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 | Baseline | 0.00 z-score | Standard Deviation 0.91 |
| Wait-list Control | 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 | Week 3 | -0.14 z-score | Standard Deviation 1.02 |
| Wait-list Control | 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 | Week 1 | -0.10 z-score | Standard Deviation 0.95 |
| Wait-list Control | 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 | Week 16 | -0.24 z-score | Standard Deviation 1 |
| Wait-list Control | 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 | Week 2 | -0.10 z-score | Standard Deviation 1.01 |
Secondary
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.
Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Change From Baseline on the Drexel Defusion Scale (DDS) | baseline | 24.83 score on a scale | Standard Deviation 7.89 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Drexel Defusion Scale (DDS) | Week 1 | 27.14 score on a scale | Standard Deviation 8.72 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Drexel Defusion Scale (DDS) | Week 2 | 28.45 score on a scale | Standard Deviation 8.42 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Drexel Defusion Scale (DDS) | Week 3 | 29.61 score on a scale | Standard Deviation 8.73 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Drexel Defusion Scale (DDS) | Week 4 | 31.43 score on a scale | Standard Deviation 8.54 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Drexel Defusion Scale (DDS) | Week 16 | 30.93 score on a scale | Standard Deviation 8.69 |
| Wait-list Control | Change From Baseline on the Drexel Defusion Scale (DDS) | Week 4 | 27.92 score on a scale | Standard Deviation 8.63 |
| Wait-list Control | Change From Baseline on the Drexel Defusion Scale (DDS) | baseline | 24.45 score on a scale | Standard Deviation 8.23 |
| Wait-list Control | Change From Baseline on the Drexel Defusion Scale (DDS) | Week 3 | 27.52 score on a scale | Standard Deviation 9.07 |
| Wait-list Control | Change From Baseline on the Drexel Defusion Scale (DDS) | Week 1 | 26.26 score on a scale | Standard Deviation 8.31 |
| Wait-list Control | Change From Baseline on the Drexel Defusion Scale (DDS) | Week 16 | 28.23 score on a scale | Standard Deviation 8.57 |
| Wait-list Control | Change From Baseline on the Drexel Defusion Scale (DDS) | Week 2 | 26.96 score on a scale | Standard Deviation 8.73 |
Secondary
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.
Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | baseline | 24.80 score on a scale | Standard Deviation 5.93 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | Week 1 | 24.19 score on a scale | Standard Deviation 5.62 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | Week 2 | 25.71 score on a scale | Standard Deviation 5.47 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | Week 3 | 26.45 score on a scale | Standard Deviation 5.61 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | Week 4 | 27.12 score on a scale | Standard Deviation 5.67 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | Week 16 | 27.1 score on a scale | Standard Deviation 5.32 |
| Wait-list Control | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | Week 4 | 26.12 score on a scale | Standard Deviation 6.76 |
| Wait-list Control | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | baseline | 24.56 score on a scale | Standard Deviation 6.12 |
| Wait-list Control | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | Week 3 | 26.15 score on a scale | Standard Deviation 6.21 |
| Wait-list Control | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | Week 1 | 25.57 score on a scale | Standard Deviation 6.15 |
| Wait-list Control | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | Week 16 | 26.02 score on a scale | Standard Deviation 6.36 |
| Wait-list Control | Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale | Week 2 | 25.69 score on a scale | Standard Deviation 6.44 |
Secondary
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).
Time frame: baseline, 4 weeks (post intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Change From Baseline on the Growth Mindset Scale for Well-Being | baseline | 5.00 score on a scale | Standard Deviation 0.83 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Growth Mindset Scale for Well-Being | 4 weeks | 5.18 score on a scale | Standard Deviation 0.81 |
| Wait-list Control | Change From Baseline on the Growth Mindset Scale for Well-Being | baseline | 4.94 score on a scale | Standard Deviation 0.85 |
| Wait-list Control | Change From Baseline on the Growth Mindset Scale for Well-Being | 4 weeks | 4.87 score on a scale | Standard Deviation 0.87 |
Secondary
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.
Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Change From Baseline on the Meaning in Life Questionnaire | baseline | 26.20 score on a scale | Standard Deviation 5.44 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Meaning in Life Questionnaire | Week 1 | 26.83 score on a scale | Standard Deviation 5.13 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Meaning in Life Questionnaire | Week 2 | 27.15 score on a scale | Standard Deviation 5.14 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Meaning in Life Questionnaire | Week 3 | 27.62 score on a scale | Standard Deviation 4.92 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Meaning in Life Questionnaire | Week 4 | 27.85 score on a scale | Standard Deviation 5.35 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Meaning in Life Questionnaire | Week 16 | 27.91 score on a scale | Standard Deviation 5.14 |
| Wait-list Control | Change From Baseline on the Meaning in Life Questionnaire | Week 4 | 26.02 score on a scale | Standard Deviation 6.07 |
| Wait-list Control | Change From Baseline on the Meaning in Life Questionnaire | baseline | 25.81 score on a scale | Standard Deviation 5.46 |
| Wait-list Control | Change From Baseline on the Meaning in Life Questionnaire | Week 3 | 26.13 score on a scale | Standard Deviation 5.83 |
| Wait-list Control | Change From Baseline on the Meaning in Life Questionnaire | Week 1 | 26.02 score on a scale | Standard Deviation 5.38 |
| Wait-list Control | Change From Baseline on the Meaning in Life Questionnaire | Week 16 | 26.29 score on a scale | Standard Deviation 5.87 |
| Wait-list Control | Change From Baseline on the Meaning in Life Questionnaire | Week 2 | 25.85 score on a scale | Standard Deviation 5.68 |
Secondary
Change From Baseline on the Neutral Face Rating Task: Prosocial Construal
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.
Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Change From Baseline on the Neutral Face Rating Task: Prosocial Construal | baseline | 4.46 score on a scale | Standard Deviation 0.6 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Neutral Face Rating Task: Prosocial Construal | 4 weeks | 4.42 score on a scale | Standard Deviation 0.65 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Neutral Face Rating Task: Prosocial Construal | 16 weeks | 4.44 score on a scale | Standard Deviation 0.63 |
| Wait-list Control | Change From Baseline on the Neutral Face Rating Task: Prosocial Construal | baseline | 4.44 score on a scale | Standard Deviation 0.68 |
| Wait-list Control | Change From Baseline on the Neutral Face Rating Task: Prosocial Construal | 4 weeks | 4.27 score on a scale | Standard Deviation 0.59 |
| Wait-list Control | Change From Baseline on the Neutral Face Rating Task: Prosocial Construal | 16 weeks | 4.37 score on a scale | Standard Deviation 0.6 |
Secondary
Change From Baseline on the Neutral Face Rating Task: Race Bias
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).
Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Change From Baseline on the Neutral Face Rating Task: Race Bias | baseline | -0.57 score on a scale | Standard Deviation 0.67 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Neutral Face Rating Task: Race Bias | 4 weeks | -0.54 score on a scale | Standard Deviation 0.68 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Neutral Face Rating Task: Race Bias | 16 weeks | -0.51 score on a scale | Standard Deviation 0.69 |
| Wait-list Control | Change From Baseline on the Neutral Face Rating Task: Race Bias | baseline | -0.50 score on a scale | Standard Deviation 0.68 |
| Wait-list Control | Change From Baseline on the Neutral Face Rating Task: Race Bias | 4 weeks | -0.55 score on a scale | Standard Deviation 0.73 |
| Wait-list Control | Change From Baseline on the Neutral Face Rating Task: Race Bias | 16 weeks | -0.46 score on a scale | Standard Deviation 0.67 |
Secondary
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.
Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Change From Baseline on the NIH Toolbox Loneliness Scale | Week 1 | 2.34 score on a scale | Standard Deviation 0.75 |
| Healthy Minds Program Foundations Training | Change From Baseline on the NIH Toolbox Loneliness Scale | baseline | 2.53 score on a scale | Standard Deviation 0.77 |
| Healthy Minds Program Foundations Training | Change From Baseline on the NIH Toolbox Loneliness Scale | Week 4 | 2.07 score on a scale | Standard Deviation 0.71 |
| Healthy Minds Program Foundations Training | Change From Baseline on the NIH Toolbox Loneliness Scale | Week 2 | 2.16 score on a scale | Standard Deviation 0.72 |
| Healthy Minds Program Foundations Training | Change From Baseline on the NIH Toolbox Loneliness Scale | Week 16 | 2.13 score on a scale | Standard Deviation 0.75 |
| Healthy Minds Program Foundations Training | Change From Baseline on the NIH Toolbox Loneliness Scale | Week 3 | 2.02 score on a scale | Standard Deviation 0.68 |
| Wait-list Control | Change From Baseline on the NIH Toolbox Loneliness Scale | Week 16 | 2.38 score on a scale | Standard Deviation 0.82 |
| Wait-list Control | Change From Baseline on the NIH Toolbox Loneliness Scale | baseline | 2.58 score on a scale | Standard Deviation 0.77 |
| Wait-list Control | Change From Baseline on the NIH Toolbox Loneliness Scale | Week 1 | 2.49 score on a scale | Standard Deviation 0.74 |
| Wait-list Control | Change From Baseline on the NIH Toolbox Loneliness Scale | Week 2 | 2.38 score on a scale | Standard Deviation 0.72 |
| Wait-list Control | Change From Baseline on the NIH Toolbox Loneliness Scale | Week 3 | 2.37 score on a scale | Standard Deviation 0.75 |
| Wait-list Control | Change From Baseline on the NIH Toolbox Loneliness Scale | Week 4 | 2.33 score on a scale | Standard Deviation 0.81 |
Secondary
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.
Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Change From Baseline on the Perseverative Thought Questionnaire | baseline | 29.89 score on a scale | Standard Deviation 10.43 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Perseverative Thought Questionnaire | Week 4 | 24.75 score on a scale | Standard Deviation 10.71 |
| Healthy Minds Program Foundations Training | Change From Baseline on the Perseverative Thought Questionnaire | Week 16 | 23.47 score on a scale | Standard Deviation 10.74 |
| Wait-list Control | Change From Baseline on the Perseverative Thought Questionnaire | baseline | 29.62 score on a scale | Standard Deviation 11.29 |
| Wait-list Control | Change From Baseline on the Perseverative Thought Questionnaire | Week 4 | 28.19 score on a scale | Standard Deviation 12.37 |
| Wait-list Control | Change From Baseline on the Perseverative Thought Questionnaire | Week 16 | 25.91 score on a scale | Standard Deviation 12.19 |
Secondary
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.
Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale | baseline | 12.76 score on a scale | Standard Deviation 4.71 |
| Healthy Minds Program Foundations Training | Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale | Week 4 | 15.07 score on a scale | Standard Deviation 4.33 |
| Healthy Minds Program Foundations Training | Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale | Week 16 | 14.07 score on a scale | Standard Deviation 4.64 |
| Wait-list Control | Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale | baseline | 12.47 score on a scale | Standard Deviation 4.33 |
| Wait-list Control | Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale | Week 4 | 12.83 score on a scale | Standard Deviation 4.84 |
| Wait-list Control | Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale | Week 16 | 12.59 score on a scale | Standard Deviation 4.74 |
Secondary
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.
Time frame: 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Proximity Subscale | 4.45 score on a scale | Standard Deviation 1.63 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Resource Subscale | 1.81 score on a scale | Standard Deviation 1.2 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | News Subscale | 3.50 score on a scale | Standard Deviation 1.58 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Symptoms Subscale | 1.89 score on a scale | Standard Deviation 1.38 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Psychological Subscale | 3.98 score on a scale | Standard Deviation 1.46 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Threat Subscale | 4.81 score on a scale | Standard Deviation 1.36 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Financial Subscale | 2.91 score on a scale | Standard Deviation 1.97 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Threat Subscale | 4.90 score on a scale | Standard Deviation 1.33 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Financial Subscale | 3.01 score on a scale | Standard Deviation 2.07 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | News Subscale | 3.67 score on a scale | Standard Deviation 1.49 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Proximity Subscale | 4.56 score on a scale | Standard Deviation 1.6 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Psychological Subscale | 4.18 score on a scale | Standard Deviation 1.58 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Resource Subscale | 1.90 score on a scale | Standard Deviation 1.27 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Symptoms Subscale | 2.13 score on a scale | Standard Deviation 1.48 |
Secondary
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.
Time frame: 4 weeks (post intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Proximity Subscale | 3.36 score on a scale | Standard Deviation 1.67 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Resource Subscale | 1.85 score on a scale | Standard Deviation 1.17 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | News Subscale | 3.67 score on a scale | Standard Deviation 1.55 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Symptoms Subscale | 1.57 score on a scale | Standard Deviation 1.06 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Psychological Subscale | 3.96 score on a scale | Standard Deviation 1.55 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Threat Subscale | 4.64 score on a scale | Standard Deviation 1.38 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Financial Subscale | 3.10 score on a scale | Standard Deviation 2.08 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Threat Subscale | 4.74 score on a scale | Standard Deviation 1.39 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Financial Subscale | 2.93 score on a scale | Standard Deviation 2.02 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | News Subscale | 3.66 score on a scale | Standard Deviation 1.53 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Proximity Subscale | 3.41 score on a scale | Standard Deviation 1.73 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Psychological Subscale | 4.13 score on a scale | Standard Deviation 1.54 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Resource Subscale | 1.97 score on a scale | Standard Deviation 1.34 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Symptoms Subscale | 1.82 score on a scale | Standard Deviation 1.24 |
Secondary
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.
Time frame: baseline
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Proximity Subscale | 3.16 score on a scale | Standard Deviation 1.7 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Resource Subscale | 2.13 score on a scale | Standard Deviation 1.85 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | News Subscale | 4.03 score on a scale | Standard Deviation 1.65 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Symptoms Subscale | 1.65 score on a scale | Standard Deviation 1.1 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Psychological Subscale | 4.45 score on a scale | Standard Deviation 1.45 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Threat Subscale | 5.05 score on a scale | Standard Deviation 1.35 |
| Healthy Minds Program Foundations Training | Conway COVID Questionnaire Subscale Scores | Financial Subscale | 3.09 score on a scale | Standard Deviation 2.08 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Threat Subscale | 5.03 score on a scale | Standard Deviation 1.3 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Financial Subscale | 3.00 score on a scale | Standard Deviation 2.02 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | News Subscale | 4.10 score on a scale | Standard Deviation 1.55 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Proximity Subscale | 2.99 score on a scale | Standard Deviation 1.66 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Psychological Subscale | 4.39 score on a scale | Standard Deviation 1.44 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Resource Subscale | 2.00 score on a scale | Standard Deviation 1.28 |
| Wait-list Control | Conway COVID Questionnaire Subscale Scores | Symptoms Subscale | 1.70 score on a scale | Standard Deviation 1.17 |
Secondary
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.
Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Population: not all participants returned surveys for each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Self-Compassion Scale Short Form Score | baseline | 35.7 score on a scale | Standard Deviation 8.25 |
| Healthy Minds Program Foundations Training | Self-Compassion Scale Short Form Score | Week 4 | 40.1 score on a scale | Standard Deviation 8.75 |
| Healthy Minds Program Foundations Training | Self-Compassion Scale Short Form Score | Week 16 | 40.3 score on a scale | Standard Deviation 7.62 |
| Wait-list Control | Self-Compassion Scale Short Form Score | baseline | 35.2 score on a scale | Standard Deviation 8.42 |
| Wait-list Control | Self-Compassion Scale Short Form Score | Week 4 | 36.4 score on a scale | Standard Deviation 9.36 |
| Wait-list Control | Self-Compassion Scale Short Form Score | Week 16 | 38.0 score on a scale | Standard Deviation 9.28 |
Other Pre-specified
Digital Working Alliance
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.
Time frame: After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only
Other Pre-specified
Slope Across Time on Practice Quality and Mood Items
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).
Time frame: Every other day when participant completes a practice (up to 4 weeks)