The Lived Experiences Measured Using Rings Pilot Study

NCT05841979 | Completed Phase 2

• 1 other identifier: LEMURS S23
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Stress; Sleep; Anxiety

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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 Arms (4)

group-based therapy

EXPERIMENTAL

Group therapy delivered via moodlifters

Behavioral: Moodlifters

physical activity

EXPERIMENTAL

Physical Activity and Exercise

Behavioral: Physical Activity

nature experience

EXPERIMENTAL

Nature Experiences

Behavioral: Nature Experiences

self-monitoring

NO INTERVENTION

Placebo control

Interventions

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.

group-based therapy

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).

physical activity

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.

nature experience

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Vermont: lead
• MassMutual - Private Industry Funded: collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

• Price M, Hidalgo JE, Bird YM, Bloomfield LSP, Buck C, Cerutti J, Dodds PS, Fudolig MI, Gehman R, Hickok M, Kim J, Llorin J, Lovato J, McGinnis EW, McGinnis RS, Norton R, Ramirez V, Stanton K, Ricketts TH, Danforth CM. A large clinical trial to improve well-being during the transition to college using wearables: The lived experiences measured using rings study. Contemp Clin Trials. 2023 Oct;133:107338. doi: 10.1016/j.cct.2023.107338. Epub 2023 Sep 16.

  PMID: 37722484 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 3, 2023
• Study Start: December 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 17, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)