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Project MiCRIM- Sleep and Stress Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05384067
Enrollment
31
Registered
2022-05-20
Start date
2022-05-01
Completion date
2023-03-31
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep, Stress

Keywords

mindfulness, sleep, stress

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.

Interventions

BEHAVIORALMindfulness-based intervention

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.

Sponsors

Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Intervention and control group

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Saliva Samples via ELISA Assay- CortisolChange from baseline to 5 weeksTests for level changes in cortisol.
Saliva Samples via ELISA Assay- α-amylaseChange from baseline to 5 weeksTest for level changes in α-amylase.
Saliva Samples via ELISA Assay- interleukin-1betaChange from baseline to 5 weeksTest for level changes in interleukin-1beta.
Saliva Samples via ELISA Assay- interleukin-6Change from baseline to 5 weeksTest for level changes in interleukin-6.
Saliva Samples via ELISA Assay- interleukin-8Change from baseline to 5 weeksTest for level changes in interleukin-8.
Saliva Samples via ELISA Assay- TNF-αChange from baseline to 5 weeksTest for level changes in TNF-α.

Secondary

MeasureTime frameDescription
Generalized Anxiety Disorder 7Change from baseline to 5 weeksAssesses 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.
Sleep Condition IndicatorChange from baseline to 5 weeksEight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria.
The PTSD Checklist for DSM-5 (PCL-5)Change from baseline to 5 weeksAssesses 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).
Perceived Stress ScaleChange from baseline to 5 weeksAssesses 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.
Pittsburgh Sleep Quality Index (PSQI)Change from baseline to 5 weeksAssesses 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.
Pittsburgh Sleep Quality Index, Addendum for PTSD (PSQI-A)Change from baseline to 5 weeksAssesses 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.
The Smith Relaxation Dispositions InventoryChange from baseline to 5 weeksAssesses 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).
Five Facet Mindfulness Questionnaire - Short FormChange from baseline to 5 weeksAssesses 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.
Patient Health Questionnaire 9Change from baseline to 5 weeksMeasures 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026