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Completed

NCT Number: NCT05518656

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

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.

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Key information

Conditions

Emotion Regulation Behavior Emotional Regulation Self-Control Social Behavior

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental intervention

Behavioral

Daily lessons received by email to be completed the same day

comparison intervention

Behavioral

Daily lessons receive by email to be completed the same day

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Mind and Life Institute, Hadley, Massachusetts

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2022
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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