Project MiCRIM- Sleep and Stress Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep, Stress

Intervention / Treatment
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* Behavioral: Mindfulness-based intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention and control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based intervention<br>Participants in this arm will wear a sleep-monitoring device, complete questionnaires and participate in an online mindfulness component each week for the duration of this study. | Behavioral: Mindfulness-based intervention<br>* Participants will 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.<br>|
| No Intervention: Control<br>Participants in this arm will only wear a sleep-monitoring device and complete questionnaires. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva Samples via ELISA Assay- Cortisol | Tests for level changes in cortisol. | Change from baseline to 5 weeks | 
| Saliva Samples via ELISA Assay- α-amylase | Test for level changes in α-amylase. | Change from baseline to 5 weeks | 
| Saliva Samples via ELISA Assay- interleukin-1beta | Test for level changes in interleukin-1beta. | Change from baseline to 5 weeks | 
| Saliva Samples via ELISA Assay- interleukin-6 | Test for level changes in interleukin-6. | Change from baseline to 5 weeks | 
| Saliva Samples via ELISA Assay- interleukin-8 | Test for level changes in interleukin-8. | Change from baseline to 5 weeks | 
| Saliva Samples via ELISA Assay- TNF-α | Test for level changes in TNF-α. | Change from baseline to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index (PSQI) | Assesses sleep quality. The PSQI includes a scoring key for calculating a patient's seven sub scores, each of which can range from 0 to 3. The sub scores are tallied, yielding a global score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. | Change from baseline to 5 weeks | 
| Pittsburgh Sleep Quality Index, Addendum for PTSD (PSQI-A) | Assesses sleep quality related to PTSD. The PSQI-A includes a scoring key for calculating a patient's scores, each of which can range from 0 to 3 with higher scores indicating worse outcomes. | Change from baseline to 5 weeks | 
| The Smith Relaxation Dispositions Inventory | Assesses momentary states of relaxation during the past two weeks. Items scored on a 4-point Likert Type scale ranging from 1 (not at all) to 4 (very much). | Change from baseline to 5 weeks | 
| Five Facet Mindfulness Questionnaire - Short Form | Assesses 5 facets of mindfulness- observation, description, awareness of actions, non-judgement and non-reaction. Items scored on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Facet scores were computed by summing the scores on the individual items. Facet scores range from 8 to 40 (except for the nonreactivity facet, which ranges from 7 to 35), with higher scores indicating more mindfulness. | Change from baseline to 5 weeks | 
| Patient Health Questionnaire 9 | Measures depression severity. This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 0- not at all, 1- several days, 2- more than half the days, 3- nearly every day, respectively. The total score for the nine items ranges from 0 to 27. 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression. | Change from baseline to 5 weeks | 
| Generalized Anxiety Disorder 7 | Assesses anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity. Scores above 10 are considered to be in the clinical range. | Change from baseline to 5 weeks | 
| Perceived Stress Scale | Assesses perceptions of stress. Scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. | Change from baseline to 5 weeks | 
| Sleep Condition Indicator | Eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. | Change from baseline to 5 weeks | 
| The PTSD Checklist for DSM-5 (PCL-5) | Assesses the 20 Diagnostic Statistical Manual-5 symptoms of PTSD using a 5-point Likert-type scale ranging from 0 (not at all) to 4 (extremely). | Change from baseline to 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, sleep, stress