A Phase 2 interventional study of Moodlifters and Physical Activity in Depression, Stress and Sleep, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by University of Vermont · Phase 2, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 188 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
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Exclusion Criteria:
Group therapy delivered via moodlifters
Behavioral: Moodlifters
Physical Activity and Exercise
Behavioral: Physical Activity
Nature Experiences
Behavioral: Nature Experiences
Placebo control
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.
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).
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.
Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)
Self Reported Depression
Time frame: Change in depression scores from time of randomization through 5 months
Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)
Self ReportedAnxiety
Time frame: Change in anxiety scores from time of randomization through 5 months
Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)
Self Reported Stress
Time frame: Change in stress scores from time of randomization through 5 months
Well-Being as measured by Warwick-Edinburgh Mental Well-being Scale
Self Reported well-being
Time frame: Change in well-being scores from time of randomization through 5 months
Stress as measured by the Perceived Stress Scale
Self Reported subclinical stress
Time frame: Change in stress scores from time of randomization through 5 months
Sleep Quality Index
Self Reported Sleep
Time frame: Change in sleep quality scores from time of randomization through 5 months
Oura Ring Sleep Index
Biometric Sleep recorded from an Oura Ring
Time frame: Change in Oura Sleep measured scores from time of randomization through 5 months
Medical Outcomes Social Support Survey
Social Support
Time frame: Change in social support scores scores from time of randomization through 5 months
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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University of Vermont