College Student Stress: Transitions Over Time

NCT06583096 | Completed Results

• 2 other identifiers: HUM00257547K23MH131761
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Symptoms

Keywords

First-year college student; Surveys; Supportive text messages; Stress; Personalized feedback

Outcome Measures

Primary Outcomes (8)

• Percentage of Eligible Participants Who Agreed to Participate in the Trial

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

Assessment Only

OTHER

Weekly surveys only.

Behavioral: Surveys

Intervention - surveys, text messages, and feedback reports

EXPERIMENTAL

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; Behavioral: Supportive Text messages; Behavioral: Personalized Feedback (PF) Report

Interventions

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.

Assessment Only; Intervention - surveys, text messages, and feedback reports

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.

Intervention - surveys, text messages, and feedback reports

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.

Intervention - surveys, text messages, and feedback reports

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Adam Horwitz
• Organization: University of Michigan

ahor@med.umich.edu

(734) 764-0231

Study Officials

• Adam Horwitz, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: After initial survey (screening) is received, participants that are eligible for the trial and complete the baseline assessments will be assigned (3:1) to the "Assessment Only" (n = 30) or the "Intervention" (n=90) condition". The intervention arm contains two components: personalized feedback reports and supportive text messages. Each week participants are randomized, with a 2:1 probability to receive (versus not receive) a personalized feedback report, and a 2:1 probability to receive (versus not receive) supportive text messages during the week. For those randomized to receive text messages in a given week, there is a daily 50:50 randomization to receive (or not receive) a text message.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 3, 2024
• Study Start: October 1, 2024
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 4, 2025
• Results First Posted: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)