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| ID | Type | Description | Link |
|---|---|---|---|
| A171600 | Other Identifier | UW Madison | |
| EDUC/COUNSELING PSYCH | Other Identifier | UW Madison | |
| Protocol Approval 10/15/2020 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Chan Zuckerberg Initiative | OTHER |
| Healthy Minds Innovations | OTHER |
| Center for Healthy Minds | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Minds Program Foundations Training | Experimental | 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. |
|
| Wait-list control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Every other day when participant completes a practice (up to 4 weeks) |
| Digital Working Alliance |
Inclusion Criteria:
Exclusion Criteria:
Individuals under 18 years old
Significant meditation experience:
Patient-Reported Outcomes Measurement Information System (PROMIS) depression score > 70
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34000843 | Result | Goldberg SB, Baldwin SA, Riordan KM, Torous J, Dahl CJ, Davidson RJ, Hirshberg MJ. Alliance With an Unguided Smartphone App: Validation of the Digital Working Alliance Inventory. Assessment. 2022 Sep;29(6):1331-1345. doi: 10.1177/10731911211015310. Epub 2021 May 18. | |
| 37379444 | Result | Hirshberg MJ, Davidson RJ, Goldberg SB. Educators Are Not Alright: Mental Health During COVID-19. Educ Res. 2023 Jan;52(1):48-52. doi: 10.3102/0013189X221142595. |
| Label | URL |
|---|---|
| OSF Registry | View source |
Not provided
Data will be de-identified and listed in public data registries (i.e., osf) based on the publication of preregistered study hypotheses on a manuscript by manuscript basis.
Data will be de-identified and made publicly available based on the publication of preregistered study hypotheses following peer review.
Researcher consent. Any reasonable request will be granted.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | z-score | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
|
up to 16 weeks
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score <55, 55≥ <60, 60≥ <70, and ≥70; Pilkonis et al., 2011).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| None to Slight Depression at Baseline | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Hirshberg | Center for Healthy Minds | 608-262-0035 | hirshberg@wisc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2022 | Jan 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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Random parallel assignment
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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.
|
|
| 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: 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. | baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
| 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). | 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) |
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. |
| After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only |
| 41809576 | Derived | Goldberg SB, Jiwani Z, Dahl CJ, Tatar R, Dunne JD, Davidson RJ, Hirshberg MJ. Sitting and Active Meditation Practice: Utilization and Associations with Outcomes in Naturalistic and Clinical Trial Data. Mindfulness (N Y). 2026 Mar 9. doi: 10.1007/s12671-026-02787-w. Online ahead of print. |
| 39347788 | Derived | Goldberg SB, Bolt DM, Dahl CJ, Davidson RJ, Hirshberg MJ. Does it matter how meditation feels? An experience sampling study. J Consult Clin Psychol. 2024 Aug;92(8):531-541. doi: 10.1037/ccp0000857. |
| 37768631 | Derived | Webb CA, Hirshberg MJ, Gonzalez O, Davidson RJ, Goldberg SB. Revealing subgroup-specific mechanisms of change via moderated mediation: A meditation intervention example. J Consult Clin Psychol. 2024 Jan;92(1):44-53. doi: 10.1037/ccp0000842. Epub 2023 Sep 28. |
| 36346668 | Derived | Webb CA, Hirshberg MJ, Davidson RJ, Goldberg SB. Personalized Prediction of Response to Smartphone-Delivered Meditation Training: Randomized Controlled Trial. J Med Internet Res. 2022 Nov 8;24(11):e41566. doi: 10.2196/41566. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Participants were permitted to select more than one category. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Highest Level of Education | Count of Participants | Participants |
|
| Household Income | Count of Participants | Participants |
|
| Employment Category | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
|
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
|
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
|
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
|
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | 4 weeks (post intervention) |
|
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | 16 weeks (3 months post-intervention) |
|
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
|
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
|
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
|
|
|
| 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. | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
|
|
|
| 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). | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention) |
|
|
|
| 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). | not all participants returned surveys for each time point | Posted | Mean | Standard Deviation | score on a scale | baseline, 4 weeks (post intervention) |
|
|
|
| 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). | Not Posted | Every other day when participant completes a practice (up to 4 weeks) | Participants |
| 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. | Not Posted | After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only | Participants |
| 0 |
| 344 |
| 0 |
| 344 |
| 344 |
| 344 |
| EG001 | 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. | 0 | 318 | 0 | 318 | 318 | 318 |
| Mild Depression at Baseline | Nervous system disorders | Systematic Assessment |
|
| Moderate Depression at Baseline | Nervous system disorders | Systematic Assessment |
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| Severe Depression at Baseline | Nervous system disorders | Systematic Assessment |
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| None to Slight Depression at 4 weeks | Nervous system disorders | Systematic Assessment |
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| Mild Depression at 4 weeks | Nervous system disorders | Systematic Assessment |
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| Moderate Depression at 4 weeks | Nervous system disorders | Systematic Assessment |
|
| Severe Depression at 4 weeks | Nervous system disorders | Systematic Assessment |
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| None to Slight Depression at 16 weeks | Nervous system disorders | Systematic Assessment |
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| Mild Depression at 16 weeks | Nervous system disorders | Systematic Assessment |
|
| Moderate Depression at 16 weeks | Nervous system disorders | Systematic Assessment |
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| Severe Depression at 16 weeks | Nervous system disorders | Systematic Assessment |
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| None to Slight Anxiety at Baseline | Nervous system disorders | Systematic Assessment |
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| Mild Anxiety at Baseline | Nervous system disorders | Systematic Assessment |
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| Moderate Anxiety at Baseline | Nervous system disorders | Systematic Assessment |
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| Severe Anxiety at Baseline | Nervous system disorders | Systematic Assessment |
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| None to Slight Anxiety at 4 weeks | Nervous system disorders | Systematic Assessment |
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| Mild Anxiety at 4 weeks | Nervous system disorders | Systematic Assessment |
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| Moderate Anxiety at 4 weeks | Nervous system disorders | Systematic Assessment |
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| Severe Anxiety at 4 weeks | Nervous system disorders | Systematic Assessment |
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| None to Slight Anxiety at 16 weeks | Nervous system disorders | Systematic Assessment |
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| Mild Anxiety at 16 weeks | Nervous system disorders | Systematic Assessment |
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| Moderate Anxiety at 16 weeks | Nervous system disorders | Systematic Assessment |
|
| Severe Anxiety at 16 weeks | Nervous system disorders | Systematic Assessment |
|
Not provided
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| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D015928 | Cognitive Behavioral Therapy |
| Week 1 |
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| Week 16 |
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| Proximity Subscale |
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| Psychological Subscale |
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| Resource Subscale |
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| Symptoms Subscale |
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| Threat Subscale |
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| News Subscale |
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| Proximity Subscale |
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| Psychological Subscale |
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| Resource Subscale |
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| Symptoms Subscale |
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| Threat Subscale |
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| Proximity Subscale |
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| Psychological Subscale |
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| Resource Subscale |
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| Symptoms Subscale |
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| Threat Subscale |
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| Week 4 |
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| Week 16 |
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| Week 4 |
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| Week 16 |
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| Week 4 |
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| Week 16 |
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| 4 weeks |
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| 16 weeks |
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| 4 weeks |
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| 16 weeks |
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| 4 weeks |
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