Skip to main content
OpenTrials
Completed

NCT Number: NCT05841979

The Lived Experiences Measured Using Rings Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Vermont

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Moodlifters

Behavioral

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.

Physical activity

Behavioral

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).

Nature Experiences

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Sleep Quality Index

    Time frame: Change in sleep quality scores from time of randomization through 5 months

    Self Reported Sleep

  2. Oura Ring Sleep Index

    Time frame: Change in Oura Sleep measured scores from time of randomization through 5 months

    Biometric Sleep recorded from an Oura Ring

  3. Medical Outcomes Social Support Survey

    Time frame: Change in social support scores scores from time of randomization through 5 months

    Social Support

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • MassMutual - Private Industry Funded

Registry information

Acronym: LEMURS-P

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 3, 2023
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.