College Student Stress: Transitions Over Time

September 1, 2024 updated by: Adam Horwitz, University of Michigan

This research study is being conducted to better understand how college students develop and cope with stress and to identify opportunities to help students notice and respond to stress early before symptoms contribute to significant negative consequences.

This project will be completed in two parts. In the first part (not a trial) participants will be asked to complete a screening survey to determine eligibility. Eligible participants (i.e., those with mild-to-moderate depressive symptoms and not receiving mental health care) will continue into the clinical trial portion (part two). It is anticipated that 100 students will continue to the clinical trial phase of the study, where they will be randomly assigned to the "assessment only" (n=25) or "intervention" (n=75) conditions.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • First-year college students that are full-time or part-time students enrolled at the University of Michigan, Ann Arbor or Flint campuses
  • Mild-to-moderate depressive symptoms, and are not receiving professional mental health services will be eligible

Exclusion Criteria:

  • Under the age of 17
  • Currently be receiving mental health therapy/counseling from a healthcare professional
  • Experiencing minimal depressive symptoms (defined in protocol)
  • Experiencing moderately severe to severe depressive symptoms (defined in protocol)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of eligible participants that agree to participate in the trial
Time Frame: 10-20 days after screen survey
10-20 days after screen survey
Percentage of completed follow-ups
Time Frame: Baseline up to six-week follow-up
Baseline up to six-week follow-up
Percentage of participants that remain active (i.e. do not request to stop messages) on the text-message group
Time Frame: Baseline up to six-week follow-up
Baseline up to six-week follow-up
Number of withdrawals
Time Frame: Baseline up to six-week follow-up
Baseline up to six-week follow-up
Total percent of feedback reports that were viewed across all sent feedback reports
Time Frame: Baseline up to six-week follow-up
Baseline up to six-week follow-up
Percent of participants (in the intervention arm) that viewed a personalized feedback report at least once
Time Frame: Baseline up to six-week follow-up
Baseline up to six-week follow-up
Participant self-reported satisfaction with the intervention components
Time Frame: Six-week follow-up
There are 8 questions regarding satisfaction (1-Strongly disagree, 4 Neither agree nor disagree, 7-Strongly Agree) that the participant will complete regarding the study. Additionally, two questions will be open ended to collect information about the study. A higher score means more satisfaction with the study.
Six-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

September 1, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

September 1, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00257547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified IPD will be shared upon request following publication of primary results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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