Clinical trial NCT06630897: Art and Science of Human Flourishing Microsupport Study
Official title: Art and Science of Human Flourishing Microsupport Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Stress
Keywords: Wellbeing
Digital Support
Microsupport
text messages
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Currently enrolled in ASHF course

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Daily Informal Practice
timeFrame: Data collected each evening throughout the intervention (up to 1 month)
measure: Daily psychological distress
timeFrame: Data collected each evening throughout the intervention (up to 1 month)
Secondary outcomes:
measure: Composite Psychological Distress Score
timeFrame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: NIH Toolbox Loneliness Score
timeFrame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: PROMIS Sleep Disturbance Score
timeFrame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: Drexel Defusion Scale score
timeFrame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: Experiences Questionnaire Decentering Score
timeFrame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: Sense of Belonging Score
timeFrame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: Five Facet Mindfulness Questionnaire Awareness Subscale Score
timeFrame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: Healthy Minds Index Scores
timeFrame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: Digital Working Alliance Inventory (D-WAI) Score
timeFrame: 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: Mindfulness Adherence Questionnaire Score
timeFrame: 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: Alcohol Use Disorders Identification Test Score
timeFrame: baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)
measure: Morning mindfulness, decentering, connection, purpose, depression, anxiety, stress, rumination, and motivation to practice scores
timeFrame: Each morning throughout the intervention (up to 1 month)
measure: Sleep quality scores
timeFrame: Each morning throughout the intervention (up to 1 month)
measure: Evening mindfulness, decentering, connection, purpose, happy event, stressor exposure, rumination scoring
timeFrame: Each evening throughout the intervention (up to 1 month)
measure: Percentage of Participants with a formal practice
timeFrame: Each evening throughout the intervention (up to 1 month)
measure: Acceptability of Intervention Measure Score
timeFrame: 1 month (immediately post-intervention)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Center for Healthy Minds
name: Simon Goldberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: