- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06630897
Art and Science of Human Flourishing Microsupport Study
Study Overview
Detailed Description
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
- Awareness: Focus, Emotions, Mindfulness
- Connection: Interdependence, Compassion, Diversity
- Wisdom: Identity, Values, Gratitude
- Integration: Courage, Community
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53706
- University of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Currently enrolled in ASHF course
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Microsupport
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small amounts of digital support will be in the form of text messages
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No Intervention: No Microsupport
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily Informal Practice
Time Frame: Data collected each evening throughout the intervention (up to 1 month)
|
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
Time Frame: Data collected each evening throughout the intervention (up to 1 month)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite Psychological Distress Score
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
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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baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
|
NIH Toolbox Loneliness Score
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
5-item survey scored from 1 (never) to 5 (always), where higher overall scores indicate higher loneliness.
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baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
|
PROMIS Sleep Disturbance Score
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
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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.
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baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
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Drexel Defusion Scale score
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
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
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
11-item survey scored from 1 (never) to 5 (all the time), where higher overall scores indicate higher levels of decentering.
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baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
|
Sense of Belonging Score
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
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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.
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baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
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|
Five Facet Mindfulness Questionnaire Awareness Subscale Score
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
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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.
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baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
|
Healthy Minds Index Scores
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
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.
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baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
|
Digital Working Alliance Inventory (D-WAI) Score
Time Frame: 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
6-item survey scored from 1 (strongly disagree) to 7 (strongly agree), where higher overall scores indicate higher digital working alliance.
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1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
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Mindfulness Adherence Questionnaire Score
Time Frame: 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
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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.
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1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
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Alcohol Use Disorders Identification Test Score
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
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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.
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baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
|
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Morning mindfulness, decentering, connection, purpose, depression, anxiety, stress, rumination, and motivation to practice scores
Time Frame: Each morning throughout the intervention (up to 1 month)
|
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.
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Each morning throughout the intervention (up to 1 month)
|
|
Sleep quality scores
Time Frame: Each morning throughout the intervention (up to 1 month)
|
For sleep quality, participants will respond on a Likert scale (1 = very bad, 4 = very good).
A higher score indicates better sleep quality.
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Each morning throughout the intervention (up to 1 month)
|
|
Evening mindfulness, decentering, connection, purpose, happy event, stressor exposure, rumination scoring
Time Frame: Each evening throughout the intervention (up to 1 month)
|
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.
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Each evening throughout the intervention (up to 1 month)
|
|
Percentage of Participants with a formal practice
Time Frame: Each evening throughout the intervention (up to 1 month)
|
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.
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Each evening throughout the intervention (up to 1 month)
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Acceptability of Intervention Measure Score
Time Frame: 1 month (immediately post-intervention)
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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.
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1 month (immediately post-intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Simon Goldberg, PhD, Center for Healthy Minds
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0929
- A171600 (Other Identifier: UW Madison)
- Protocol Version 10/21/24 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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