Clinical trial NCT05841979: The Lived Experiences Measured Using Rings Pilot Study
Official title: The Lived Experiences Measured Using Rings Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Stress
Sleep
Anxiety
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: MassMutual - Private Industry Funded
First posted: 2023-05-03
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)
timeFrame: Change in depression scores from time of randomization through 5 months
measure: Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)
timeFrame: Change in anxiety scores from time of randomization through 5 months
measure: Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)
timeFrame: Change in stress scores from time of randomization through 5 months
measure: Well-Being as measured by Warwick-Edinburgh Mental Well-being Scale
timeFrame: Change in well-being scores from time of randomization through 5 months
measure: Stress as measured by the Perceived Stress Scale
timeFrame: Change in stress scores from time of randomization through 5 months
Secondary outcomes:
measure: Sleep Quality Index
timeFrame: Change in sleep quality scores from time of randomization through 5 months
measure: Oura Ring Sleep Index
timeFrame: Change in Oura Sleep measured scores from time of randomization through 5 months
measure: Medical Outcomes Social Support Survey
timeFrame: Change in social support scores scores from time of randomization through 5 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Laura Bloomfield, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Chris Danforth, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Ryan McGinnis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Ellen McGinnis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Matthew Price, PhD
role: PRINCIPAL_INVESTIGATOR
References: