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OpenTrials
Completed

NCT Number: NCT06583096

College Student Stress: Transitions Over Time

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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Surveys

Behavioral

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.

Supportive Text messages

Behavioral

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.

Personalized Feedback (PF) Report

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Number of Withdrawals

    Time frame: Baseline up to six-week follow-up

    Results reflect participants who requested to withdraw from the trial.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 3, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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