College Student Stress: Transitions Over Time

NCT ID: NCT06583096

Last Updated: 2025-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2024-11-27

Brief Summary

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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

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Conditions

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Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Assessment Only

Weekly surveys only.

Group Type OTHER

Surveys

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Surveys

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Adam Horwitz

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Horwitz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K23MH131761

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00257547

Identifier Type: -

Identifier Source: org_study_id

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