Art and Science of Human Flourishing Microsupport Study

March 12, 2025 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Currently enrolled in ASHF course

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Microsupport
small amounts of digital support will be in the form of text messages
No Intervention: No Microsupport

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.
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.
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)
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
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.
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)
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
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
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
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.
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.
1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
Mindfulness Adherence Questionnaire Score
Time Frame: 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
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
Time Frame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
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
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.
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.
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.
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.
Each evening throughout the intervention (up to 1 month)
Acceptability of Intervention Measure Score
Time Frame: 1 month (immediately post-intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Simon Goldberg, PhD, Center for Healthy Minds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2024

Primary Completion (Actual)

March 5, 2025

Study Completion (Actual)

March 5, 2025

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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