Clinical trial NCT05384067: Project MiCRIM- Sleep and Stress Intervention
Official title: Defining Stress and Sleep as Modifiable Intervention Targets in Correctional Officers to Reduce Mental and Physical Health Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Stress
Keywords: mindfulness
sleep
stress
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and control group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

-Criminal Justice or Criminology major

Exclusion Criteria:

* 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

Primary outcomes:
measure: Saliva Samples via ELISA Assay- Cortisol
timeFrame: Change from baseline to 5 weeks
measure: Saliva Samples via ELISA Assay- α-amylase
timeFrame: Change from baseline to 5 weeks
measure: Saliva Samples via ELISA Assay- interleukin-1beta
timeFrame: Change from baseline to 5 weeks
measure: Saliva Samples via ELISA Assay- interleukin-6
timeFrame: Change from baseline to 5 weeks
measure: Saliva Samples via ELISA Assay- interleukin-8
timeFrame: Change from baseline to 5 weeks
measure: Saliva Samples via ELISA Assay- TNF-α
timeFrame: Change from baseline to 5 weeks
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline to 5 weeks
measure: Pittsburgh Sleep Quality Index, Addendum for PTSD (PSQI-A)
timeFrame: Change from baseline to 5 weeks
measure: The Smith Relaxation Dispositions Inventory
timeFrame: Change from baseline to 5 weeks
measure: Five Facet Mindfulness Questionnaire - Short Form
timeFrame: Change from baseline to 5 weeks
measure: Patient Health Questionnaire 9
timeFrame: Change from baseline to 5 weeks
measure: Generalized Anxiety Disorder 7
timeFrame: Change from baseline to 5 weeks
measure: Perceived Stress Scale
timeFrame: Change from baseline to 5 weeks
measure: Sleep Condition Indicator
timeFrame: Change from baseline to 5 weeks
measure: The PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change from baseline to 5 weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University Center for Translational Behavioral Medicine
state: Florida
Study officials:
References: