Mental StressNCT06630897
Art and Science of Human Flourishing Microsupport Study
A study testing Text Messages in people with Mental Stress, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Stress
- What is being tested?
- Text Messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to 5 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently enrolled in ASHF course
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mental Stress
- Being tested
- Text Messages
- Keywords
- Wellbeing, Digital Support, Microsupport, text messages
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessagesOther
small amounts of digital support will be in the form of text messages
| Study group | Role | What they receive |
|---|---|---|
| Microsupport | Experimental | Not described Receives: Other: Text Messages |
| No Microsupport | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Data collected each evening throughout the intervention (up to 1 month)
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month (immediately post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start7 Oct 2024
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental StressStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Goldberg, PhD, Principal investigator, Center for Healthy Minds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630897
- Sponsor's protocol ID
- 2024-0929
- Other IDs
- A171600, Protocol Version 10/21/24
- Status last verified
- Mar 2025
- First submitted
- 3 Oct 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art and Science of Human Flourishing Microsupport Study
- ClinicalTrials.gov ID
- NCT06630897
- Acronym / sponsor ID
- 2024-0929
- Conditions
- Mental Stress
- Keywords
- Wellbeing, Digital Support, Microsupport, text messages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microsupport | Experimental | Other: Text Messages |
| No Microsupport | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently enrolled in ASHF course
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Messagessmall amounts of digital support will be in the form of text messages | Other | Microsupport |
Primary outcome
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.
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.
16 secondary outcomes
Composite Psychological Distress Score
Time frame: 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)
PROMIS Sleep Disturbance Score
Time frame: 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)
Experiences Questionnaire Decentering Score
Time frame: 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)
Five Facet Mindfulness Questionnaire Awareness Subscale Score
Time frame: 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)
Digital Working Alliance Inventory (D-WAI) Score
Time frame: 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)
Alcohol Use Disorders Identification Test Score
Time frame: 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)
Sleep quality scores
Time frame: 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)
Percentage of Participants with a formal practice
Time frame: Each evening throughout the intervention (up to 1 month)
Acceptability of Intervention Measure Score
Time frame: 1 month (immediately post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- The Art and Science of Human Flourishing CourseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Goldberg, PhD principal investigator
Center for Healthy Minds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messages in people with Mental Stress, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Informal Practice (time frame: Data collected each evening throughout the intervention (up to 1 month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.