Emotion RegulationNCT05518656
Effects and Mechanisms of Smartphone-Based Stress Management Training on Well-Being in College Students
A study testing Experimental intervention and Comparison intervention in people with Emotion Regulation, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- Experimental intervention and Comparison intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 23 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of major depression, generalized anxiety, and panic disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Emotion Regulation
- Being tested
- Experimental intervention, Comparison intervention
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental interventionBehavioural
Daily lessons received by email to be completed the same day
Comparison interventionBehavioural
Daily lessons receive by email to be completed the same day
| Study group | Role | What they receive |
|---|---|---|
| Online emotion regulation training version 1 | Experimental | Not described Receives: Behavioral: Experimental intervention |
| Online emotion regulation training version 2 | Active comparator | Not described Receives: Behavioral: Comparison intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in loneliness
Loneliness will be measured with the UCLA Loneliness Scale an instrument assessing frequency of felt social disconnection.
Measured: Baseline to the end of the semester, up to 15 weeks
Change in social connection
Connection to others will be measured with the Two-Way Social Support Scale
Measured: Baseline to the end of the semester, up to 15 weeks
Change in depression
Depressive symptoms will be measured using Center for Epidemiologic Studies Depression Scale
Measured: Baseline to the end of the semester, up to 15 weeks
Change in anxiety
Anxiety symptoms will be measured using Beck's Anxiety Inventory
Measured: Baseline to the end of the semester, up to 15 weeks
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.
Measured: Baseline to the end of the intervention, 4 weeks
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.
Measured: Baseline to the end of the intervention, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start15 Feb 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts
- Responsible party
- Sponsor
- Investigators
- Kirk Brown, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518656
- Sponsor's protocol ID
- HM20024191
- Status last verified
- Jul 2024
- First submitted
- 24 Aug 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Smartphone-Based Stress Management Training on Well-Being in College Students
- ClinicalTrials.gov ID
- NCT05518656
- Acronym / sponsor ID
- HM20024191
- Conditions
- Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Mind and Life Institute, Hadley, Massachusetts
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online emotion regulation training version 1 | Experimental | Behavioral: Experimental intervention |
| Online emotion regulation training version 2 | Active comparator | Behavioral: Comparison intervention |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- Diagnosis of major depression, generalized anxiety, and panic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental interventionDaily lessons received by email to be completed the same day | Behavioural | Online emotion regulation training version 1 |
| Comparison interventionDaily lessons receive by email to be completed the same day | Behavioural | Online emotion regulation training version 2 |
Primary outcome
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.
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
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Emotion Regulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk Brown, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental intervention and Comparison intervention in people with Emotion Regulation, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in loneliness (time frame: Baseline to the end of the semester, up to 15 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.