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

Completed

• Conditions: Mental Health Issue
• Interventions: Behavioral: Wellness coaching plus app use

• Registration Number: NCT05736445
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Students seeking wellness coaching will have the option to participate in this study. The study will ask participants 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

5. 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.

Study Timeline

• Study Start: 2023-01-08
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-21
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. University of Michigan students aged 18 years or older.
2. Students must either be coming to campus for the academic year or taking classes online for the academic year.
3. 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
4. Possess a smartphone (Apple or Android).
5. Ability to understand and demonstrate willingness to remotely sign a written informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Students at the University of Michigan	Wellness coaching plus app use	Students enrolled in the Winter 2023 academic semester at the University of Michigan

Primary Outcome Measures

Name	Time	Method
Wellness Coaching + App Use	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 Outcome Measures

Name	Time	Method
Survey Completion	7 months	Assess survey completion rate, estimating 50% of participants will complete the surveys at all four time points

Trial Locations

Locations (1)

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