Clinical trial NCT05518656: Effects and Mechanisms of Smartphone-Based Stress Management Training on Well-Being in College Students
Official title: Effects and Mechanisms of Smartphone-Based Stress Management Training on Well-Being in College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Mind and Life Institute, Hadley, Massachusetts
First posted: 2022-08-26
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in loneliness
timeFrame: Baseline to the end of the semester, up to 15 weeks
measure: Change in social connection
timeFrame: Baseline to the end of the semester, up to 15 weeks
measure: Change in depression
timeFrame: Baseline to the end of the semester, up to 15 weeks
measure: Change in anxiety
timeFrame: Baseline to the end of the semester, up to 15 weeks
measure: Changes in daily experiences
timeFrame: Baseline to the end of the intervention, 4 weeks
measure: Changes in daily well-being
timeFrame: Baseline to the end of the intervention, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Kirk Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: