- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05518656
Effects and Mechanisms of Smartphone-Based Stress Management Training on Well-Being in College Students
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Kirk Brown, PhD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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