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OpenTrials
Completed

NCT Number: NCT06804213

Student Wellness 2.0

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.

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Key information

Conditions

Mental Health Issue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

Study participants will be asked to:

  • Complete as many sessions of individual wellness coaching as they see fit
  • Install and interact with the Fitbit and Roadmap 2.0 apps on their smartphone
  • Complete longitudinal surveys at baseline, month 1, month 2, and end of study
  • Complete an exit interview at the end of the study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be at least 18 years old.
  • Students must be either enrolled at the University of Michigan OR in the STEER transition program.
  • 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).
  • Possess a smartphone (Apple or Android).
  • Ability to understand and demonstrate willingness to remotely sign a written informed consent document

Exclusion criteria

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

Treatment and study plan

Mobile health app with positive psychological activities

Behavioral

Mobile health app with step tracking, sleep tracking, and positive psychological activities

Primary outcomes

  1. Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental health

    Time frame: 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 outcomes

  1. Survey completion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • STEER for Student Athletes

Registry information

Official study title

A Randomized Controlled Study Evaluating Student Wellness Using the Roadmap mHealth App and Wellness Coaching

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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