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| ID | Type | Description | Link |
|---|---|---|---|
| A171600 | Other Identifier | UW Madison | |
| EDUC/COUNSELING PSYCH | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Thrive Foundation | UNKNOWN |
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The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. 32 participants will be enrolled and can expect to be on study for up to 4 weeks.
The overall purpose of this study is to help determine the feasibility and acceptability of incorporating small amounts of human and digital support into a meditation app. Ultimately, the investigators hope this work will help to develop digital tools that can reduce symptoms of depression and/or anxiety. The meditation app of interest is the Healthy Minds Program (HMP). The HMP app provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.
Participants will be randomly assigned to receive or not receive an initial coaching call with a team member. Participants will also be randomly assigned to receive or not receive access to email-based support. All participants with receive text messages encouraging them to engage in the practices taught in the app.
Participants will complete a set of questionnaires at baseline and post-test (following the 4-week intervention period). Questionnaires and items will be selected from the set of questionnaires included in this application. The average length of time to complete questionnaires will be within 15 to 30 minutes. Participants will also receive short daily surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Interventional Coaching Call Plus Email Support | Active Comparator |
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| Initial Interventional Coaching Call No Email Support | Active Comparator |
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| Initial Informational Coaching Call Plus Email Support | Active Comparator |
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| Initial Informational Coaching Call No Email Support | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial Coaching Call | Other | Participant will receive initial coaching call with a team member. This coaching call will either be interventional (i.e., include content intended to prompt their adherence and benefit from the HMP app) or informational (i.e., include content intended to control for the time and attention of attending a coaching session, but not intended to provide specific benefits). |
| Measure | Description | Time Frame |
|---|---|---|
| Study completion rate | Percentage of participants completing pre- and post-test measures | Baseline to 4 weeks (post-intervention) |
| Daily diary completion rate | Percentage of daily assessments completed | Baseline to 4 weeks (post-intervention) |
| Acceptability of Intervention Score | 12-item survey scored from 1 - 5 where higher scores indicate more acceptability. | 4 weeks (post-intervention) |
| Modified System Usability Scale Score | 10-item survey scored from 1-5 where higher scores indicate more usability. | 4 weeks (post-intervention) |
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| Measure | Description | Time Frame |
|---|---|---|
| Attitudes Towards Psychological Online Interventions Score | 16-item survey scored from 1 - 5 where higher scores indicate more positive attitude in each of 4 domains: skepticism, confidence, threat, anonymity. | 4 weeks (post-intervention) |
| Determinants of Meditation Practice Inventory Score |
Inclusion Criteria:
Adults (age ≥18) who have recently downloaded the HMP app
Elevated symptoms of depression and/or anxiety
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Goldberg, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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Participants will not be informed which version of the introductory coaching session they are receiving.
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| Email Support | Other | Email-based support throughout study period |
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| Text Messages | Other | All participants with receive text messages encouraging them to engage in the practices taught in the app. |
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12-item survey scored from 1 - 5 where lower scores indicate lower perceived barriers to meditation practice in each of 4 domains; benefit, knowledge, pragmatic, cultural. |
| baseline (pre-intervention) |
| Patient Health Questionnaire - 9 (PHQ-9) Score | 9-item survey scored from 0-27 where higher scores indicate increased depression. | baseline (pre-intervention), 4 weeks (post-intervention) |
| PROMIS Meaning and Purpose Score | Computer adaptive survey scored from 1-5 where higher scores indicate higher sense of meaning and purpose. | baseline (pre-intervention), 4 weeks (post-intervention) |
| Digital Working Alliance Inventory (D-WAI) Score | 6-item survey scored from 1-7 where higher scores indicate increased trust in the app in each of three domains: goals, tasks, bond. | 4 weeks (post-intervention) |
| Five Facet Mindfulness Questionnaire (FFMQ): Awareness Score | 8-item survey scored from 1-5 where higher scores indicate lower levels of awareness. | baseline (pre-intervention), 4 weeks (post-intervention) |
| General Anxiety Disorder -7 (GAD-7) Score | 7-item survey scored from 0-21 where higher scores indicate increased anxiety. | screening, 4 weeks (post-intervention) |
| Mindfulness Adherence Questionnaire: Minutes of meditation per week | Minutes of meditation practice completed per week | 4 weeks (post-intervention) |
| Mindfulness Adherence Questionnaire Score | 10-item survey scored from 0-6 where higher scores indicate higher quality meditation practice in two domains: formal practice, informal practice. | 4 weeks (post-intervention) |
| Healthy Minds Index Score | 17-item survey scored from 0-4 where higher scores indicate healthier attitude in each of 4 domains: awareness, connection, insight, purpose. | baseline (pre-intervention), 4 weeks (post-intervention) |
| NIH Toolbox: Loneliness Score | 5-item survey scored from 1-5 where higher scores indicate increased loneliness. | baseline (pre-intervention), 4 weeks (post-intervention) |
| Growth Mindset Scale for Well-Being Score | 3-item survey scored from 1-6 where higher score lower growth mindset. | baseline (pre-intervention), 4 weeks (post-intervention) |
| Experiences Questionnaire Decentering Score | 11-item survey scored from 1-5 where higher scores indicate higher levels of decentering. | baseline (pre-intervention), 4 weeks (post-intervention) |
| Daily Diary Assessment Question Scores | 9-items administered in the morning scored from 1 (not at all) to 5 (very much) for domain: mindfulness, decentering, connection, purpose, depression, anxiety, stress, rumination, motivation. 11-items administered in the evening scored from 1 (not at all) to 5 (very much) for domain: mindfulness, decentering, connection, purpose, depression, anxiety, happy event, stressor exposure item, rumination, informal practice item, formal practice item. | daily from baseline to post-test (week 4) |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |