The Lived Experiences Measured Using Rings Pilot Study

NCT ID: NCT05841979

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group-based therapy

Group therapy delivered via moodlifters

Group Type: EXPERIMENTAL

Moodlifters

Intervention Type: 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

Physical Activity and Exercise

Group Type: EXPERIMENTAL

Physical Activity

Intervention Type: 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 experience

Nature Experiences

Group Type: EXPERIMENTAL

Nature Experiences

Intervention Type: 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.

self-monitoring

Placebo control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MassMutual - Private Industry Funded

UNKNOWN

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Matthew Price

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Bloomfield, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Chris Danforth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Ryan McGinnis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Ellen McGinnis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Matthew Price, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of Vermont

Burlington, Vermont, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37722484 (View on PubMed)

Other Identifiers

LEMURS S23

Identifier Type: -

Identifier Source: org_study_id