College Student Stress: Transitions Over Time

Not Applicable

Completed

• Conditions: Depressive Symptoms
• Interventions: Behavioral: Surveys; Behavioral: Supportive Text messages; Behavioral: Personalized Feedback (PF) Report

• Registration Number: NCT06583096
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-09-01
• Study First Posted: 2024-09-03
• Study Start: 2024-10-01
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assessment Only	Surveys	Weekly surveys only.
Intervention - surveys, text messages, and feedback reports	Surveys	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.
Intervention - surveys, text messages, and feedback reports	Supportive Text messages	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.
Intervention - surveys, text messages, and feedback reports	Personalized Feedback (PF) Report	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.

Primary Outcome Measures

Name	Time	Method
Percentage of eligible participants that agree to participate in the trial	10-20 days after screen survey
Percentage of completed follow-ups	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	Baseline up to six-week follow-up
Number of withdrawals	Baseline up to six-week follow-up
Total percent of feedback reports that were viewed across all sent feedback reports	Baseline up to six-week follow-up
Percent of participants (in the intervention arm) that viewed a personalized feedback report at least once	Baseline up to six-week follow-up
Participant self-reported satisfaction with the intervention components	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States