跳至主要内容
临床试验/NCT05384067
NCT05384067已完成不适用

Defining Stress and Sleep as Modifiable Intervention Targets in Correctional Officers to Reduce Mental and Physical Health Risk

Florida State University2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Saliva Samples via ELISA Assay- α-amylase

研究概览

简要总结

The purpose of Project MiCRIM is to test the feasibility and effectiveness of an online 4-week mindfulness-based intervention that incorporates informational elements about sleep, mindfulness, thoughts, emotions, and acceptance using a control sample of Criminology and Criminal Justice majors as a proxy for Corrections officers.

详细描述

The study will use a waitlist-control design to examine the effectiveness of a brief (4-week) online mindfulness-based intervention aimed at reducing stress and improving sleep quality. A proxy, convenience sample of 50 criminology majors will be recruited and randomized into the active intervention or waitlist condition. The intervention requires participants to complete one mindfulness education module every week for 4 weeks, and to practice a 15-minute formal guided mindfulness meditation at least five times per week across the 4 weeks. Participants will also be taught evidence-based sleep improvement techniques, will be provided education for when to use the techniques, and will be encouraged to implement the techniques to improve sleep. Validated self-report measures of stress, anxiety, mood, and sleep quality will be assessed pre- and post-intervention. Adherence to the mindfulness practice will be monitored online and self-report assessments of sleep technique implementation will be collected. Sleep patterns will be assessed using a Philips Respironics Spectrum 2 Actiwatch, which is a wrist-worn device that measures movement and light exposure and estimates sleep-wake patterns. Lastly, multiple saliva samples pre- and post-intervention will be collected and analyzed by ELISA with a multiplex cytokine assay. Cortisol, α-amylase, and the four analytes with known deleterious roles in cellular and behavioral stress responsiveness will be measured simultaneously: interleukin-1beta, interleukin-6, interleukin-8, and Tumour Necrosis Factor-alpha will be examined pre- and post-intervention.

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
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Criminal Justice or Criminology major

排除标准

  • Abnormal BMI (below 18.5 or above 30)
  • self-reported sleep apnea, head injury, neurological problem, unstable mental health disorder, substance use disorder, psychosis, or current suicidal ideation or plan

结局指标

主要结局

Saliva Samples via ELISA Assay- α-amylase

时间窗: Change from baseline to 5 weeks

Test for level changes in α-amylase.

Saliva Samples via ELISA Assay- interleukin-1beta

时间窗: Change from baseline to 5 weeks

Test for level changes in interleukin-1beta.

Saliva Samples via ELISA Assay- Cortisol

时间窗: Change from baseline to 5 weeks

Tests for level changes in cortisol.

Saliva Samples via ELISA Assay- interleukin-6

时间窗: Change from baseline to 5 weeks

Test for level changes in interleukin-6.

Saliva Samples via ELISA Assay- TNF-α

时间窗: Change from baseline to 5 weeks

Test for level changes in TNF-α.

Saliva Samples via ELISA Assay- interleukin-8

时间窗: Change from baseline to 5 weeks

Test for level changes in interleukin-8.

次要结局

  • The Smith Relaxation Dispositions Inventory(Change from baseline to 5 weeks)
  • Generalized Anxiety Disorder 7(Change from baseline to 5 weeks)
  • The PTSD Checklist for DSM-5 (PCL-5)(Change from baseline to 5 weeks)
  • Five Facet Mindfulness Questionnaire - Short Form(Change from baseline to 5 weeks)
  • Perceived Stress Scale(Change from baseline to 5 weeks)
  • Sleep Condition Indicator(Change from baseline to 5 weeks)
  • Pittsburgh Sleep Quality Index, Addendum for PTSD (PSQI-A)(Change from baseline to 5 weeks)
  • Pittsburgh Sleep Quality Index (PSQI)(Change from baseline to 5 weeks)
  • Patient Health Questionnaire 9(Change from baseline to 5 weeks)

研究者

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

Scott Pickett

Associate Professor

Florida State University

研究点 (2)

Loading locations...

相似试验

Project MiCRIM- Sleep and Stress Intervention | 临床试验