The Lived Experiences Measured Using Rings Pilot Study (LEMURS-P)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stress; Sleep; Anxiety
• Intervention / Treatment: Behavioral: Moodlifters; Behavioral: Physical Activity; Behavioral: Nature Experiences

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group-based therapy; Group therapy delivered via moodlifters	Behavioral: Moodlifters; Mood Lifters, a novel mental wellness program, was developed as a more accessible means to provide psychotherapy (Votta & Deldin, 2022). Meetings covered biopsychosocial areas and skills that were drawn from multiple therapeutic interventions consistent with a biopsychosocial framework. Areas included physical health, negative thoughts, problem-solving, emotional awareness and regulation, building relationships, behavioral activation, and using a strengths-based approach. ML is delivered by peer leaders who are individuals that have completed the program as well as a training program.
Experimental: physical activity; Physical Activity and Exercise	Behavioral: Physical Activity; Participants randomized to the exercise arm received 14 weeks of a structured weekly strength and conditioning training program to enhance muscle mass, strength, cardiorespiratory fitness, and overall well-being. The program is based on previous research showing that cardiorespiratory fitness and muscle strength/size can both contribute to decreased mortality/increased longevity and enhanced mental health (Burke et al., 2017; McLeod et al., 2016; Srikanthan & Karlamangla, 2014; Strasser & Burtscher, 2018). The training program consists of three training sessions per week, with one being an in-person group session guided by a certified strength and conditioning specialist. The other two training sessions are self-guided via the mobile app Trainheroic. This weekly training schedule aligns with previous research showing benefits to structuring an exercise program using a variety of social contexts (group setting, own, etc.; Burke et al., 2017).
Experimental: nature experience; Nature Experiences	Behavioral: Nature Experiences; Participants randomized to the Nature Experiences participated in 14 weeks of group and self-directed activities to connect with the natural environment. Weekly group activities will be led by Nature Guides, who are undergraduate and graduate students with extensive outdoor education training. Group activities will last one hour a week and include hiking in forests, walking in parks, bird-watching, mindfulness exercises, and snow activities. Participants will be given a list of self-directed activity suggestions each week. The goal of self-directed activities is to spend an additional two hours in a natural environment each week.
No Intervention: self-monitoring; Placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)	Self Reported Depression	Change in depression scores from time of randomization through 5 months
Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)	Self ReportedAnxiety	Change in anxiety scores from time of randomization through 5 months
Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)	Self Reported Stress	Change in stress scores from time of randomization through 5 months
Well-Being as measured by Warwick-Edinburgh Mental Well-being Scale	Self Reported well-being	Change in well-being scores from time of randomization through 5 months
Stress as measured by the Perceived Stress Scale	Self Reported subclinical stress	Change in stress scores from time of randomization through 5 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: MassMutual - Private Industry Funded
• Investigators: Principal Investigator: Laura Bloomfield, MD, PhD, University of Vermont; Principal Investigator: Chris Danforth, PhD, University of Vermont; Principal Investigator: Ryan McGinnis, PhD, University of Vermont; Principal Investigator: Ellen McGinnis, PhD, University of Vermont; Principal Investigator: Matthew Price, PhD, University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: LEMURS S23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No