NCT06244043

Human and Digital Support Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. 32 participants will be enrolled and can expect to be on study for up to 4 weeks.

Detailed description

The overall purpose of this study is to help determine the feasibility and acceptability of incorporating small amounts of human and digital support into a meditation app. Ultimately, the investigators hope this work will help to develop digital tools that can reduce symptoms of depression and/or anxiety. The meditation app of interest is the Healthy Minds Program (HMP). The HMP app provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices. Participants will be randomly assigned to receive or not receive an initial coaching call with a team member. Participants will also be randomly assigned to receive or not receive access to email-based support. All participants with receive text messages encouraging them to engage in the practices taught in the app. Participants will complete a set of questionnaires at baseline and post-test (following the 4-week intervention period). Questionnaires and items will be selected from the set of questionnaires included in this application. The average length of time to complete questionnaires will be within 15 to 30 minutes. Participants will also receive short daily surveys.

Conditions

• Depression
• Anxiety

Interventions

Type	Name	Description
OTHER	Initial Coaching Call	Participant will receive initial coaching call with a team member. This coaching call will either be interventional (i.e., include content intended to prompt their adherence and benefit from the HMP app) or informational (i.e., include content intended to control for the time and attention of attending a coaching session, but not intended to provide specific benefits).
OTHER	Email Support	Email-based support throughout study period
OTHER	Text Messages	All participants with receive text messages encouraging them to engage in the practices taught in the app.

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-06-02
• Completion: 2024-06-02
• First posted: 2024-02-06
• Last updated: 2024-08-19

Locations

1 site across 1 country: United States