College Student Stress: Transitions Over Time

November 19, 2025 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). There were 120 students in the clinical trial phase of the study, where 30 were randomly assigned to "assessment only" and 90 to the "intervention" condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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 Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Assessment Only
Weekly surveys only.
Behavioral: Surveys
Participants (in both arms) will complete surveys once per week and participants in the intervention arm will also complete additional 1-minute surveys daily. Study participation will be completed at the conclusion of the final follow-up survey administered 6-weeks after study enrollment.
Experimental: Intervention - surveys, text messages, and feedback reports

Participants in the intervention arm will be randomized to receive (or not receive) text messages in a given week, with a daily randomization to receive (or not receive) a text message if randomized to receive text messages that week.

Additionally, participants will be randomized each week to receive (or not receive) personalized feedback reports.
Behavioral: Surveys
Participants (in both arms) will complete surveys once per week and participants in the intervention arm will also complete additional 1-minute surveys daily. Study participation will be completed at the conclusion of the final follow-up survey administered 6-weeks after study enrollment.
Behavioral: Supportive Text messages
Text messages will be sent Mondays-Sunday if participants are randomized to receive them in a given week, with a daily 50:50 send/no-send randomization. A bank of 25 text messages will be used for the study, providing tips/strategies across a range of topics, including managing time and academic stressors, recommendations for self-care and mood management, and messages geared towards fostering social connections and support. Some messages will contain links to videos, websites, or articles for more information on a topic.
Behavioral: Personalized Feedback (PF) Report
For individuals that are randomized to receive a Personalized Feedback Report, the study team will send participants a text on a Monday with the feedback from the prior survey (baseline survey in the first week, weekly survey in the next five weeks). There will be graphs for depression, anxiety, stress, and flourishing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eligible Participants Who Agreed to Participate in the Trial
Time Frame: Up to 10 days after screening survey
Of the individuals meeting eligibility criteria (i.e., mild-to-moderate depressive symptoms, no current mental health service utilization) from the initial screen, what percentage agreed to be enrolled and randomized into the clinical trial.
Up to 10 days after screening survey
Percentage of Participants Who Completed Follow-ups
Time Frame: Baseline up to six-week follow-up
Weekly ten-minute surveys assessing mental health symptoms, stress, and adaptive functioning were sent to participants. Results reflect the number of participants who completed their survey each week.
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
Results reflect the participants who remained active during the full trial in the intervention group.
Baseline up to six-week follow-up
Number of Withdrawals
Time Frame: Baseline up to six-week follow-up
Results reflect participants who requested to withdraw from the trial.
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
As part of the intervention arm, participants were randomized each week to receive or not receive personalized feedback reports. Reports had graphical explanations of the participant's responses to the survey questions. The data values reported reflect the number of participants who viewed feedback reports, while the Number Analyzed for each Row reflects the number of participants who were sent a personalized feedback report that week.
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
As part of the intervention, some participants in the intervention arm were randomly sent feedback reports. Reports had graphical explanations of the participant's response to the survey questions. All participants in the intervention arm were sent at least one feedback report during the course of the trial. Results reflect the number of participants who viewed at least one report.
Baseline up to six-week follow-up
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
Time Frame: Six-week follow-up
Participants in the "Assessment Only" arm who completed the 6-week follow-up survey responded to an 8-question survey regarding their satisfaction with the study. Each question was on a scale of 1 to 7 (1-Strongly disagree, 4 Neither agree nor disagree, 7-Strongly Agree). A higher score indicated more satisfaction with the study. Results reflect the average participant scores for each question.
Six-week follow-up
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
Time Frame: Six-week follow-up
Participants in the "Intervention" arm who completed the 6-week follow-up survey responded to an 18-question survey regarding their satisfaction with the intervention. Each question was on a scale of 1 to 7 (1-Strongly disagree, 4 Neither agree nor disagree, 7-Strongly Agree). A higher score indicated more satisfaction. Results reflect the average participant scores for each question.
Six-week follow-up

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Adam Horwitz, Ph.D., 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 (Actual)

October 1, 2024

Primary Completion (Actual)

November 27, 2024

Study Completion (Actual)

November 27, 2024

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 (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00257547
  • K23MH131761 (U.S. NIH Grant/Contract)

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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