NCT06630897

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

October 7, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

October 3, 2024

Last Update Submit

March 12, 2025

Conditions

Keywords

WellbeingDigital SupportMicrosupporttext messages

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Data collected each evening throughout the intervention (up to 1 month)

Secondary Outcomes (16)

  • Composite Psychological Distress Score

    baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)

  • NIH Toolbox Loneliness Score

    baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)

  • PROMIS Sleep Disturbance Score

    baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)

  • Drexel Defusion Scale score

    baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)

  • Experiences Questionnaire Decentering Score

    baseline, 1 month (immediately post-intervention), 4 months (3 month post-intervention follow up)

  • +11 more secondary outcomes

Study Arms (2)

Microsupport

EXPERIMENTAL
Other: Text Messages

No Microsupport

NO INTERVENTION

Interventions

small amounts of digital support will be in the form of text messages

Microsupport

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently enrolled in ASHF course

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Links

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Simon Goldberg, PhD

    Center for Healthy Minds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 8, 2024

Study Start

October 7, 2024

Primary Completion

March 5, 2025

Study Completion

March 5, 2025

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations