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Completed

NCT Number: NCT05736445

Evaluating Student Wellness Using a Blended Approach of the Roadmap mHealth App Plus Wellness Coaching

In this pilot study, the investigators plan to examine how the combination of wellness coaching and a mobile health app that promotes positive psychology activities can improve the overall well-being of college students. With these tools, the investigators hope to better understand the relationship between digital intervention and coaching and determine how it may improve the mental health of students. The study team also hopes to investigate how mental health can impact academic performance.

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Key information

Conditions

Mental Health Issue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

Students seeking wellness coaching will have the option to participate in this study. The study will ask participants 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
  • Allow the study team to access academic records (optional)

The investigators plan to evaluate the app + coaching influence on mental health outcomes and to determine what can be learned to improve its design for a future, full-scale study, if there is evidence of adoption and sustainability from this pilot study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • University of Michigan students aged 18 years or older.
  • Students must either be coming to campus for the academic year or taking classes online for the academic year.
  • For those completing school online, must be able to provide a mailing address within the United States where they can receive study tools and be mailed study materials
  • Possess a smartphone (Apple or Android).
  • Ability to understand and demonstrate willingness to remotely sign a written informed consent.

Exclusion criteria

  • People who are not enrolled in classes at the University of Michigan for the Winter 2023 term.
  • Unwilling or unable to comply with the study procedures.

Treatment and study plan

Wellness coaching plus app use

Behavioral

Participants will participate in wellness coaching and interact with apps on their smartphones

Primary outcomes

  1. Wellness Coaching + App Use

    Time frame: 9 months

    To assess the primary endpoint, the investigators will evaluate participants' opinions about the uptake of Roadmap + Wellness Coaching through semi-structured qualitative interviews. The investigators will ask questions related to the feasibility and acceptability of the: 1) Roadmap 2.0 app; 2) Fitbit device; 3) completing assessments (through the app); and 4) wellness coaching. The investigators expect the net favorability (agree + totally agree) of all four components will be >50% based on answering questions on a scale of totally disagree, disagree, neutral, agree, and totally agree to be considered feasible and acceptable to participate in.

Secondary outcomes

  1. Survey Completion

    Time frame: 7 months

    Assess survey completion rate, estimating 50% of participants will complete the surveys at all four time points

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Sep 21, 2023

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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