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

Emotion Regulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518656
• Other study ID #: HM20024191
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: Virginia Commonwealth University
• Contact: Polina Beloborodova
• Phone: (804) 215-6196
• Email: beloborodp[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotion Regulation

Intervention

Behavioral:
• Experimental intervention
Daily lessons received by email to be completed the same day
• Comparison intervention
Daily lessons receive by email to be completed the same day

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Mind and Life Institute, Hadley, Massachusetts

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in loneliness	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
Primary	Change in social connection	Connection to others will be measured with the Two-Way Social Support Scale	Baseline to the end of the semester, up to 15 weeks
Primary	Change in depression	Depressive symptoms will be measured using Center for Epidemiologic Studies Depression Scale	Baseline to the end of the semester, up to 15 weeks
Primary	Change in anxiety	Anxiety symptoms will be measured using Beck's Anxiety Inventory	Baseline to the end of the semester, up to 15 weeks
Primary	Changes in daily experiences	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
Primary	Changes in daily well-being	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