The Lived Experiences Measured Using Rings Pilot Study

Phase 2

Active, not recruiting

• Conditions: Stress; Sleep; Depression; Anxiety
• Interventions: Behavioral: Nature Experiences; Behavioral: Moodlifters; Behavioral: Physical Activity

• Registration Number: NCT05841979
• Lead Sponsor: University of Vermont

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-21
• Study First Posted: 2023-05-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-12-19
• Study Completion: 2027-05-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nature experience	Nature Experiences	Nature Experiences
group-based therapy	Moodlifters	Group therapy delivered via moodlifters
physical activity	Physical Activity	Physical Activity and Exercise

Primary Outcome Measures

Name	Time	Method
Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)	Change in anxiety scores from time of randomization through 5 months	Self ReportedAnxiety
Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)	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)	Change in stress scores from time of randomization through 5 months	Self Reported Stress
Stress as measured by the Perceived Stress Scale	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	Change in well-being scores from time of randomization through 5 months	Self Reported well-being

Secondary Outcome Measures

Name	Time	Method
Sleep Quality Index	Change in sleep quality scores from time of randomization through 5 months	Self Reported Sleep
Oura Ring Sleep Index	Change in Oura Sleep measured scores from time of randomization through 5 months	Biometric Sleep recorded from an Oura Ring
Medical Outcomes Social Support Survey	Change in social support scores scores from time of randomization through 5 months	Social Support

Trial Locations

Locations (1)

University of Vermont; 🇺🇸 Burlington, Vermont, United States