Wellness Interventions for Mental Health in College Students

(LEMURS-P Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Vermont

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

188 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Chris Danforth, PhD

Principal Investigator

University of Vermont

Ryan McGinnis, PhD

Principal Investigator

University of Vermont

Ellen McGinnis, PhD

Principal Investigator

University of Vermont

Matthew Price, PhD

Principal Investigator

University of Vermont

Laura Bloomfield, MD, PhD

Principal Investigator

University of Vermont

Eligibility Criteria

This study is for first-year college students who own a mobile device. It's designed to help those experiencing depression, stress, sleep issues, or anxiety as they transition into college life.

Inclusion Criteria

I am a first-year undergraduate student.

Own a mobile device

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of four arms: group-based therapy, physical activity program, nature experiences group, or self-monitoring condition as the control group. Biometric data is collected using a wearable device.

5 months

Follow-up

Participants are monitored for changes in mental health conditions, social support, and sleep quality after treatment.

4 weeks

Treatment Details

Interventions

• Moodlifters
• Nature Experiences
• Physical Activity

Trial Overview The trial tests three interventions: group-based therapy (Moodlifters), a physical activity program, and nature experiences against a control group using self-monitoring. Participants are randomly placed in one of these four groups to see which method best supports mental health.

Participant Groups

Group I: physical activity Experimental Treatment 1 Intervention

Physical Activity and Exercise

Group II: nature experience Experimental Treatment 1 Intervention

Nature Experiences

Group III: group-based therapy Experimental Treatment 1 Intervention

Group therapy delivered via moodlifters

Group IV: self-monitoring Active Control 1 Intervention

Placebo control

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

MassMutual - Private Industry Funded

Collaborator

Trials

1

Recruited

600+