NCT05518656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

August 24, 2022

Last Update Submit

July 8, 2024

Conditions

Emotion Regulation

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • Change in anxiety

    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

    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

    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

Study Arms (2)

Online emotion regulation training version 1

EXPERIMENTAL
Behavioral: Experimental intervention

Online emotion regulation training version 2

ACTIVE COMPARATOR
Behavioral: Comparison intervention

Interventions

Experimental interventionBEHAVIORAL

Daily lessons received by email to be completed the same day

Online emotion regulation training version 1
Comparison interventionBEHAVIORAL

Daily lessons receive by email to be completed the same day

Online emotion regulation training version 2

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Diagnosis of major depression, generalized anxiety, and panic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Kirk Brown, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 26, 2022

Study Start

February 15, 2023

Primary Completion

April 23, 2024

Study Completion

April 23, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)