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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
266 Previous Clinical Trials
3,743,091 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the qualification criterion for this research restricted to those 70 years of age or younger?

"This research project is open to individuals aged 18-25. However, there are separate studies targeting people under the age of 18 and those over 65 with a total number of 290 and 1,165 respectively."

Answered by AI

Who is eligible to register for this clinical trial?

"This clinical study requires prospective participants to have an official diagnosis of depression and be in the age range between 18 - 25 years old. As of now, 600 patients are needed for this trial."

Answered by AI

Is the FDA's seal of approval granted to group-based therapy?

"Based on our assessment, group-based therapy was assigned a score of 2. This is because the trial has reached Phase 2 status with some evidence to suggest safety but not efficacy."

Answered by AI

Are there any openings for this research trial at the moment?

"Unfortunately, this clinical trial is no longer recruiting participants. It was first posted on December 1st 2022 and last updated on April 21st 2023. Despite that, there are a plethora of other medical studies actively enrolling candidates at the present time - 1621 in total."

Answered by AI
~175 spots leftby Dec 2024