The Lived Experiences Measured Using Rings Pilot Study

Depression Clinical Trial

— LEMURS-P  

Official title:

The Lived Experiences Measured Using Rings Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05841979
• Other study ID #: LEMURS S23
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Est. completion date: May 19, 2027

Study information

• Verified date: March 2024
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: May 19, 2027
• Est. primary completion date: December 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Anxiety
• Depression
• Sleep
• Stress

Intervention

Behavioral:
• 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.
• 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).
• 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.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	MassMutual - Private Industry Funded

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)	Self Reported Depression	Change in depression scores from time of randomization through 5 months
Primary	Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)	Self ReportedAnxiety	Change in anxiety scores from time of randomization through 5 months
Primary	Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)	Self Reported Stress	Change in stress scores from time of randomization through 5 months
Primary	Well-Being as measured by Warwick-Edinburgh Mental Well-being Scale	Self Reported well-being	Change in well-being scores from time of randomization through 5 months
Primary	Stress as measured by the Perceived Stress Scale	Self Reported subclinical stress	Change in stress scores from time of randomization through 5 months
Secondary	Sleep Quality Index	Self Reported Sleep	Change in sleep quality scores from time of randomization through 5 months
Secondary	Oura Ring Sleep Index	Biometric Sleep recorded from an Oura Ring	Change in Oura Sleep measured scores from time of randomization through 5 months
Secondary	Medical Outcomes Social Support Survey	Social Support	Change in social support scores scores from time of randomization through 5 months