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

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05736445
• Other study ID #: HUM00223936
• Status: Completed
• Start date: January 8, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• Wellness coaching plus app use
Participants will participate in wellness coaching and interact with apps on their smartphones

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wellness Coaching + App Use	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.	9 months
Secondary	Survey Completion	Assess survey completion rate, estimating 50% of participants will complete the surveys at all four time points	7 months