NCT05736445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

January 26, 2023

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Survey Completion

    7 months

Study Arms (1)

Students at the University of Michigan

Students enrolled in the Winter 2023 academic semester at the University of Michigan

Behavioral: Wellness coaching plus app use

Interventions

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

Students at the University of Michigan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Students enrolled at the University of Michigan

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Sung Won Choi, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Edith S Briskin and Shirley K Schlafer Foundation Research Professor of Pediatrics, Professor of Pediatrics, University of Michigan Medical School

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 21, 2023

Study Start

January 8, 2023

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations