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Clinical Trials/NCT05841979
NCT05841979
Completed
Phase 2

The Lived Experiences Measured Using Rings Pilot Study

University of Vermont1 site in 1 country188 target enrollmentDecember 1, 2022

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Depression
Sponsor
University of Vermont
Enrollment
188
Locations
1
Primary Endpoint
Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The transition to college is a period of elevated risk for a range of mental health conditions. For students with pre-existing mental health diagnoses, the added pressures can exacerbate challenges. Although colleges and universities strive to provide mental health support to their students, the high demand for these services makes it difficult to provide scalable cost-effective solutions. To address these issues, the present study aims to compare the efficacy of three different treatments using a large cohort of 600 students transitioning to college. Interventions were selected based on their potential for generalizability and cost-effectiveness on college campuses. The randomized controlled trial will assign 150 participants to one of four arms: 1) group-based therapy, 2) physical activity program, 3) nature experiences group, or 4) self-monitoring condition as the control group. In addition, biometric data will be collected from all participants using a wearable device to develop algorithmic predictions of mental and physical health functioning. Once recruitment is complete, modeling strategies will be used to evaluate the outcomes and effectiveness of each intervention. The findings of this study will provide evidence as to the benefits of implementing scalable and proactive interventions using technology with the goal of improving well-being and success of new college students.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
June 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew Price

Professor

University of Vermont

Eligibility Criteria

Inclusion Criteria

  • Current undergraduate student in their first year of school
  • own a mobile device

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)

Time Frame: Change in anxiety scores from time of randomization through 5 months

Self ReportedAnxiety

Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)

Time Frame: Change in depression scores from time of randomization through 5 months

Self Reported Depression

Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)

Time Frame: Change in stress scores from time of randomization through 5 months

Self Reported Stress

Stress as measured by the Perceived Stress Scale

Time Frame: Change in stress scores from time of randomization through 5 months

Self Reported subclinical stress

Well-Being as measured by Warwick-Edinburgh Mental Well-being Scale

Time Frame: Change in well-being scores from time of randomization through 5 months

Self Reported well-being

Secondary Outcomes

  • Sleep Quality Index(Change in sleep quality scores from time of randomization through 5 months)
  • Oura Ring Sleep Index(Change in Oura Sleep measured scores from time of randomization through 5 months)
  • Medical Outcomes Social Support Survey(Change in social support scores scores from time of randomization through 5 months)

Study Sites (1)

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