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| ID | Type | Description | Link |
|---|---|---|---|
| A171600 | Other Identifier | UW Madison | |
| Protocol Version 10/21/24 | Other Identifier | UW Madison |
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The purpose of this study is to determine whether providing small amounts of digital support impacts students in the Art and Science of Human Flourishing (ASHF) course. Approximately 300 participants will be enrolled and can expect to be on study for up to 4 months.
Participants will be currently enrolled students in the ASHF course. Students will complete measures at baseline, daily during the 1-month intervention period, at post-treatment, and 3 months later. During the 1-month intervention period, half of the participants will be randomized to receive small amounts of digital support in the form of text messages.
Context (from the course website): The Art and Science of Human Flourishing course is taught in tandem with the Healthy Minds Program (HMP) app. The overall framework of the ASHF course largely aligns with the HMP app and is composed of the following modules and sub-themes which are covered throughout the course of a 15-week semester:
Foundations: Flourishing, Transformation, Resilience
Small amounts of digital support will be tested on half the participants. Primary Outcomes for measuring the effect of this support will be the PROMIS Depression and Anxiety Measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microsupport | Experimental |
| |
| No Microsupport | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Messages | Other | small amounts of digital support will be in the form of text messages |
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| Measure | Description | Time Frame |
|---|---|---|
| Daily Informal Practice | Daily informal practice will be measured by a single item: "Today, I have tried to apply the practices I have been learning in the HMP app to my day-to-day activities." Participants will respond on a Likert scale (1 = not at all, 5 = all day long). A higher score on this item indicates more informal practice on that day. | Data collected each evening throughout the intervention (up to 1 month) |
| Daily psychological distress | Daily psychological distress will be measured by two items on anxiety ("Today, I felt anxious") and depression ("Today, I felt depressed"). Participants will rate these items on a 5-point Likert scale (1 = not at all, 5 = very much). Responses to each item will be z-scored and then averaged to create a distress composite. | Data collected each evening throughout the intervention (up to 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Psychological Distress Score | A composite psychological distress score will be obtained by computing a mean across scaled (z-transformed) scores on the computer-adaptive versions of PROMIS Depression and PROMIS Anxiety Scales and NIH Toolbox 10-item Perceived Stress. For PROMIS Depression Scale, participants score 4 to 8 items on a 5 point Likert scale from 1 (never) to 5 (always) to measure how they felt in the past 7 days. For PROMIS Anxiety Scale, participants score 4 to 8 items on a 5 point Likert scale from 1 (never) to 5 (always) to measure how they felt in the past 7 days. For NIH Toolbox 10-item Perceived Stress, participants score on a 5 point Likert scale from 1 (never) to 5 (very often) to measure how they felt in the past 7 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Goldberg, PhD | Center for Healthy Minds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53706 | United States |
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| Label | URL |
|---|---|
| The Art and Science of Human Flourishing Course | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2024 | Mar 12, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| NIH Toolbox Loneliness Score | 5-item survey scored from 1 (never) to 5 (always), where higher overall scores indicate higher loneliness. | baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| PROMIS Sleep Disturbance Score | The computer adaptive version will draw from a bank of 27-items scored from 1 (never / very poor) to 5 (always / very good), where higher overall scores indicate greater sleep disturbance in the past 7 days. | baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| Drexel Defusion Scale score | 10-item survey scored from 0 (not at all) to 5 (very much), where higher overall scores indicate higher defusion. | baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| Experiences Questionnaire Decentering Score | 11-item survey scored from 1 (never) to 5 (all the time), where higher overall scores indicate higher levels of decentering. | baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| Sense of Belonging Score | 8-item survey scored from 1 (not at all true for me) to 5 (very true for me), where higher overall scores indicate higher sense of belonging. | baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| Five Facet Mindfulness Questionnaire Awareness Subscale Score | 8-item survey scored from 1 (never or very rarely true) to 5 (very often or always true) where higher overall scores indicate higher awareness. | baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| Healthy Minds Index Scores | 17-item survey scored from 0 (not at all / never / none of the time) to 4 (to the highest degree / always / all of the time) on each of 4 domains: Awareness, Connection, Insight, Purpose. Higher overall scores indicate higher sense of awareness, connection, insight, and purpose. | baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| Digital Working Alliance Inventory (D-WAI) Score | 6-item survey scored from 1 (strongly disagree) to 7 (strongly agree), where higher overall scores indicate higher digital working alliance. | 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| Mindfulness Adherence Questionnaire Score | 10-item survey scored from 0 (never) to 6 (always), where higher overall scores indicate higher quality of mindfulness practice. A four-item subscale can be computed for formal practice and a six-item subscale can be computed for informal practice. | 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| Alcohol Use Disorders Identification Test Score | 10-item survey scored from 0 (never / no / 1 or 2) to 4 (4 or more times a week / 10 or more / daily or almost daily / yes, during the past year). Higher overall scores indicate higher alcohol use concerns. | baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up) |
| Morning mindfulness, decentering, connection, purpose, depression, anxiety, stress, rumination, and motivation to practice scores | Morning mindfulness, decentering, connection, purpose, depression, anxiety, stress, rumination, and motivation to practice meditation will be measured by a single item, respectively. Participants will respond on a Likert scale (1 = not at all, 5 = very much). A higher score on these items indicates higher mindfulness, decentering, loneliness, purpose, depression, anxiety, stress, rumination, sleep quality, and motivation to practice meditation that morning. | Each morning throughout the intervention (up to 1 month) |
| Sleep quality scores | For sleep quality, participants will respond on a Likert scale (1 = very bad, 4 = very good). A higher score indicates better sleep quality. | Each morning throughout the intervention (up to 1 month) |
| Evening mindfulness, decentering, connection, purpose, happy event, stressor exposure, rumination scoring | Evening mindfulness, decentering, connection, purpose, happy event, stressor exposure, rumination, and formal practice will be measured by a single item, respectively. Participants will respond on a Likert scale (1 = not at all, 5 = very much). A higher score on the items indicates higher mindfulness, decentering, loneliness, purpose, happiness, stress, and rumination that day. | Each evening throughout the intervention (up to 1 month) |
| Percentage of Participants with a formal practice | Participants will respond yes or no to whether they have a mindfulness, decentering, connection, purpose, happy event, stressor exposure, rumination formal practice. A response of "Yes" to the formal practice item indicates that the participant used the HMP app on that day, while a response of "No" indicates non-use. | Each evening throughout the intervention (up to 1 month) |
| Acceptability of Intervention Measure Score | The Acceptability of Intervention Measure is a 4-item self-report measure scored on a 5-point likert scale from 1 (completely disagree) to 5 (completely agree), where higher scores indicate greater acceptability of the intervention. | 1 month (immediately post-intervention) |