Clinical trial NCT06583096: College Student Stress: Transitions Over Time
Official title: College Student Stress: Transitions Over Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: First-year college student
Surveys
Supportive text messages
Stress
Personalized feedback
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-09-03
Enrollment: 120
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 = 25) or the "Intervention" (n=75) 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 purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of eligible participants that agree to participate in the trial
timeFrame: 10-20 days after screen survey
measure: Percentage of completed follow-ups
timeFrame: Baseline up to six-week follow-up
measure: Percentage of participants that remain active (i.e. do not request to stop messages) on the text-message group
timeFrame: Baseline up to six-week follow-up
measure: Number of withdrawals
timeFrame: Baseline up to six-week follow-up
measure: Total percent of feedback reports that were viewed across all sent feedback reports
timeFrame: Baseline up to six-week follow-up
measure: Percent of participants (in the intervention arm) that viewed a personalized feedback report at least once
timeFrame: Baseline up to six-week follow-up
measure: Participant self-reported satisfaction with the intervention components
timeFrame: Six-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Adam Horwitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: