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临床试验/NCT05841979
NCT05841979已完成2 期

The Lived Experiences Measured Using Rings Pilot Study

University of Vermont2 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
188
试验地点
2
主要终点
Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

nature experience

Experimental

Nature Experiences

干预措施: Nature Experiences (Behavioral)

self-monitoring

No Intervention

Placebo control

group-based therapy

Experimental

Group therapy delivered via moodlifters

干预措施: Moodlifters (Behavioral)

physical activity

Experimental

Physical Activity and Exercise

干预措施: Physical Activity (Behavioral)

结局指标

主要结局

Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)

时间窗: Change in anxiety scores from time of randomization through 5 months

Self ReportedAnxiety

Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)

时间窗: Change in depression scores from time of randomization through 5 months

Self Reported Depression

Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)

时间窗: Change in stress scores from time of randomization through 5 months

Self Reported Stress

Stress as measured by the Perceived Stress Scale

时间窗: Change in stress scores from time of randomization through 5 months

Self Reported subclinical stress

Well-Being as measured by Warwick-Edinburgh Mental Well-being Scale

时间窗: Change in well-being scores from time of randomization through 5 months

Self Reported well-being

次要结局

  • Sleep Quality Index(Change in sleep quality scores from time of randomization through 5 months)
  • Oura Ring Sleep Index(Change in Oura Sleep measured scores from time of randomization through 5 months)
  • Medical Outcomes Social Support Survey(Change in social support scores scores from time of randomization through 5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Price

Professor

University of Vermont

研究点 (2)

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