Student Wellness 2.0

Not Applicable

Recruiting

• Conditions: Mental Health Issue

• Registration Number: NCT06804213
• Lead Sponsor: University of Michigan

Brief Summary

In this randomized controlled study, investigators plan to assess the impact of a mobile health app with positive psychological combined with wellness coaching on college student mental health outcomes. The study aims to differentiate the effectiveness of combining mobile health and wellness coaching compared to wellness coaching on its own. The goal is to improve our understanding of the optimal combination of traditional in-person and digital interventions on diverse student populations, as well as better understand the causal impact of the mobile health app on well-being.

Detailed Description

Study participants will be asked to:

1. Complete as many sessions of individual wellness coaching as they see fit

2. Install and interact with the Fitbit and Roadmap 2.0 apps on their smartphone

3. Complete longitudinal surveys at baseline, month 1, month 2, and end of study

4. Complete an exit interview at the end of the study

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-27
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Must be at least 18 years old.
2. Students must be either enrolled at the University of Michigan OR in the STEER transition program.
3. Potential subjects must be able to provide a mailing address within the United States where they can receive study tools and be mailed study materials (e.g., Fitbit, compensation).
4. Possess a smartphone (Apple or Android).
5. Ability to understand and demonstrate willingness to remotely sign a written informed consent document

Exclusion Criteria

1. People who are not enrolled in classes at the University of Michigan OR people who are not members of the STEER organization.
2. Unwilling or unable to comply with the study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental health	From enrollment to the exit survey at 4 months	Evaluate the difference between the intervention (Roadmap 2.0 + wellness coaching) arm and the control (limited Roadmap 2.0 + wellness coaching) arm by measuring the effectiveness of Roadmap 2.0 when coupled with wellness coaching. Participants will complete validated quality-of-life surveys, which measure subject-reported outcomes related to mental health.

Secondary Outcome Measures

Name	Time	Method
Survey completion	From enrollment to the exit survey at 4 months	Assess survey completion rate, estimating at least 50% of participants will complete the surveys at all four time points.

Trial Locations

Locations (2)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

STEER for Student Athletes; 🇺🇸 Port Chester, New York, United States