Effects and Mechanisms of Smartphone-Based Stress Management Training on Well-Being in College Students

July 8, 2024 updated by: Virginia Commonwealth University
Studying can be a difficult time, and some students can find it challenging to deal with stress. This research project at Virginia Commonwealth University aims to understand how two different online stress management training programs affect students' daily experiences and activities. This research project will help us understand how those training programs help students to improve their emotional well-being.

Study Overview

Detailed Description

Participants will be randomly assigned (like the flip of a coin) to one of the two online stress management training programs. For two weeks, participants will receive daily online lessons that will teach you how to deal with stress.

To investigate how this program affects mood, researchers will monitor participant's daily activities and experiences combining brief daily surveys with activity tracking via smartphones. The activities and experiences will be tracked for a week before the training, two weeks of the training, and one week after. Shortly after the training, researchers will also reach out to participants for a phone interview where they will ask about the training experience in more detail. Afterwards, researchers will check in with participants at the end of the semester for one more week of experience and activity tracking.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-25 years old;
  • Enrollment as a full-time student;
  • Studying in-person;
  • Reduced emotional well-being;
  • Absence of major depressive, generalized anxiety, and panic disorder diagnoses;
  • Little or no experience of the intervention;
  • Ownership of a smartphone with an OS no older than iPhone 5 or Android 5 and an active data plan.

Exclusion Criteria:

• Diagnosis of major depression, generalized anxiety, and panic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online emotion regulation training version 1
Daily lessons received by email to be completed the same day
Active Comparator: Online emotion regulation training version 2
Daily lessons receive by email to be completed the same day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in loneliness
Time Frame: Baseline to the end of the semester, up to 15 weeks
Loneliness will be measured with the UCLA Loneliness Scale an instrument assessing frequency of felt social disconnection.
Baseline to the end of the semester, up to 15 weeks
Change in social connection
Time Frame: Baseline to the end of the semester, up to 15 weeks
Connection to others will be measured with the Two-Way Social Support Scale
Baseline to the end of the semester, up to 15 weeks
Change in depression
Time Frame: Baseline to the end of the semester, up to 15 weeks
Depressive symptoms will be measured using Center for Epidemiologic Studies Depression Scale
Baseline to the end of the semester, up to 15 weeks
Change in anxiety
Time Frame: Baseline to the end of the semester, up to 15 weeks
Anxiety symptoms will be measured using Beck's Anxiety Inventory
Baseline to the end of the semester, up to 15 weeks
Changes in daily experiences
Time Frame: Baseline to the end of the intervention, 4 weeks
Smartphone passive sensing will be accomplished through AWARE which will record frequency (but not content) of short message service (SMS) text messaging and calls, location and mobility (to assess out-of-home departures), and nearby Bluetooth addresses (to assess social proximity). A conversation plugin will make surrounding sound inferences (without retaining audio recordings), including presence of other voices.
Baseline to the end of the intervention, 4 weeks
Changes in daily well-being
Time Frame: Baseline to the end of the intervention, 4 weeks
Ecological momentary assessment (EMA) will include items to measure mood, loneliness, felt social connection and school belonging, and interactions with others. EMA surveys will be administered through the AWARE app.
Baseline to the end of the intervention, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kirk Brown, PhD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Actual)

April 23, 2024

Study Completion (Actual)

April 23, 2024

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HM20024191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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