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Wellness Interventions for Mental Health in College Students (LEMURS-P Trial)

Phase 2
Waitlist Available
Led By Laura Bloomfield, MD, PhD
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in stress scores from time of randomization through 5 months
Awards & highlights

LEMURS-P Trial Summary

This trial will compare 3 treatments to improve mental health & well-being of 600 college students with biometric data & interventions.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the interventions involve therapy, exercise, and outdoor activities rather than medication, side effects may include discomfort from discussing personal issues or physical strain from new activities.

LEMURS-P Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in stress scores from time of randomization through 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in stress scores from time of randomization through 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)
Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)
Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)
+2 more
Secondary outcome measures
Medical Outcomes Social Support Survey
Oura Ring Sleep Index
Sleep Quality Index

LEMURS-P Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: physical activityExperimental Treatment1 Intervention
Physical Activity and Exercise
Group II: nature experienceExperimental Treatment1 Intervention
Nature Experiences
Group III: group-based therapyExperimental Treatment1 Intervention
Group therapy delivered via moodlifters
Group IV: self-monitoringActive Control1 Intervention
Placebo control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Activity
2019
Completed Phase 3
~4710

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
270 Previous Clinical Trials
3,743,195 Total Patients Enrolled
5 Trials studying Depression
4,697 Patients Enrolled for Depression
MassMutual - Private Industry FundedUNKNOWN
Laura Bloomfield, MD, PhDPrincipal InvestigatorUniversity of Vermont

Media Library

Moodlifters Clinical Trial Eligibility Overview. Trial Name: NCT05841979 — Phase 2
Depression Research Study Groups: group-based therapy, physical activity, nature experience, self-monitoring
Depression Clinical Trial 2023: Moodlifters Highlights & Side Effects. Trial Name: NCT05841979 — Phase 2
Moodlifters 2023 Treatment Timeline for Medical Study. Trial Name: NCT05841979 — Phase 2
~150 spots leftby Dec 2024
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