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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three methods to support mental health in new college students: group therapy (called Moodlifters), physical activity, and nature experiences. The goal is to determine which method best helps students feel better and succeed during their first year of college. Participants will wear a device that collects health data to understand how these treatments affect well-being. The study seeks first-year college students who own a mobile device. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important mental health research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on wellness interventions rather than medication changes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Moodlifters effectively and safely improves mental wellness. This simple, group-based program reduces distress without major side effects. Research indicates that participants generally handle it well, with few negative effects reported.

Spending time in nature also links to better mental health. Studies show it can boost mood, lower stress, and reduce anxiety. These activities are generally safe and have been widely used without reports of harm.

Physical activity is well-known for its mental health benefits. It improves mood and reduces symptoms of issues like anxiety and depression. Regular exercise is considered safe and beneficial for most people, with minimal risk when done properly.

Overall, these treatments are well-tolerated and previous research has shown them to be safe for improving mental health. Always consult with a healthcare provider to ensure these options are right for you. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these wellness interventions for mental health in college students because they offer unique, holistic approaches compared to traditional treatments like medication and individual therapy. Moodlifters provides group-based therapy via a structured program, promoting peer support and social connection, which can be crucial for mental well-being. Nature experiences encourage students to engage with the outdoors, which may reduce stress and enhance mood through exposure to natural environments. Additionally, the physical activity arm emphasizes the mental health benefits of exercise, known to boost endorphins and improve mood. These interventions aim to offer more accessible, sustainable, and enjoyable alternatives to conventional mental health treatments.

What evidence suggests that this trial's treatments could be effective for mental health in college students?

In this trial, participants will join different treatment arms to evaluate their effectiveness in improving mental health among college students. Mood Lifters, one possible treatment in this trial, has shown significant reductions in depression, anxiety, and stress in past research. A large majority, about 85%, reported feeling better able to manage their mental health through this program. Another treatment arm involves spending time in nature, which has been linked to better mental health; evidence shows it can boost mood and lower anxiety levels. The trial also includes a physical activity arm, as studies have shown that regular exercise strongly connects to positive mental health outcomes, reducing symptoms of anxiety and depression. These treatments all have promising data supporting their potential effectiveness for improving mental health in college students. ^{1 6 7 8 9}

Who Is on the Research Team?

Laura Bloomfield, MD, PhD

Principal Investigator

University of Vermont

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

Are You a Good Fit for This Trial?

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

Own a mobile device

I am a first-year undergraduate student.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10968146/

Mood Lifters for Graduate Students and Young Adults A total of 84.8% (117 of 138) of participants somewhat or strongly agreed that Mood Lifters enabled them to manage their mental health better ( ...

2. researchgate.net researchgate.net/publication/396933294_Addressing_Mental_Health_Needs_in_Young_Adults_A_Pilot_Analysis_of_College-Aged_Mood_Lifters_Participants/download

A Pilot Analysis of College-Aged Mood Lifters Participants Results: Analyses revealed statistically significant improvements in depression, anxiety, perceived stress, flourishing, social functioning, and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38330384/

Mood Lifters for college athletes: a biopsychosocial ... Results: Mood Lifters significantly improved participants' depression, anxiety, and self-esteem. Conclusion: Student-athletes showed ...

4. tandfonline.com tandfonline.com/doi/abs/10.1080/07448481.2024.2312421

Mood Lifters for college athletes: a biopsychosocial ... Results: Mood Lifters significantly improved participants' depression, anxiety, and self-esteem. Conclusion: Student-athletes showed improvements in mental well ...

5. sites.lsa.umich.edu sites.lsa.umich.edu/pjdeldin-lab/wp-content/uploads/sites/928/2024/08/Votta-Deldin-2022.pdf

evaluation of a novel peer-led mental wellness program Nevertheless, the significant results were promising and further data collection and analysis is being completed to understand the full effects of the program.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02558075

NCT02558075 | Mood Lifters: A Self Help Program Study Plan ; Patient Health Questionnaire, Change in depression symptomology will be measured from baseline to 15 weeks. 15 weeks post baseline assessment.

7. link.springer.com link.springer.com/article/10.1007/s41811-024-00204-5

Mood Lifters: A Dimensional Approach to Mental Health Care Mood Lifters is a 15-week, peer-led, group-based program that promotes transdiagnostic mental wellness.

8. jahonline.org jahonline.org/article/S1054-139X(25)00284-8/fulltext

Group-based Low-intensity Cognitive Behavioral Therapy ... This study investigated the effects of group-based low-intensity cognitive behavioural therapy (GB-LiCBT) on alleviating distress, ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1054139X25002848

Group-based Low-intensity Cognitive Behavioral Therapy ... This study investigated the effects of group-based low-intensity cognitive behavioural therapy (GB-LiCBT) on alleviating distress, ...