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Completed

NCT Number: NCT05384067

Project MiCRIM- Sleep and Stress Intervention

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.

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Key information

Conditions

Sleep Stress

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University Center for Translational Behavioral Medicine

Tallahassee, Florida, 32310, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based Intervention

Behavioral

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.

Primary outcomes

  1. Saliva Samples via ELISA Assay- Cortisol

    Time frame: Change from baseline to 5 weeks

    Tests for level changes in cortisol.

  2. Saliva Samples via ELISA Assay- α-amylase

    Time frame: Change from baseline to 5 weeks

    Test for level changes in α-amylase.

  3. Saliva Samples via ELISA Assay- interleukin-1beta

    Time frame: Change from baseline to 5 weeks

    Test for level changes in interleukin-1beta.

  4. Saliva Samples via ELISA Assay- interleukin-6

    Time frame: Change from baseline to 5 weeks

    Test for level changes in interleukin-6.

  5. Saliva Samples via ELISA Assay- interleukin-8

    Time frame: Change from baseline to 5 weeks

    Test for level changes in interleukin-8.

  6. Saliva Samples via ELISA Assay- TNF-α

    Time frame: Change from baseline to 5 weeks

    Test for level changes in TNF-α.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline to 5 weeks

    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.

  2. Pittsburgh Sleep Quality Index, Addendum for PTSD (PSQI-A)

    Time frame: Change from baseline to 5 weeks

    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.

  3. The Smith Relaxation Dispositions Inventory

    Time frame: Change from baseline to 5 weeks

    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).

  4. Five Facet Mindfulness Questionnaire - Short Form

    Time frame: Change from baseline to 5 weeks

    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.

  5. Patient Health Questionnaire 9

    Time frame: Change from baseline to 5 weeks

    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.

  6. Generalized Anxiety Disorder 7

    Time frame: Change from baseline to 5 weeks

    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.

  7. Perceived Stress Scale

    Time frame: Change from baseline to 5 weeks

    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.

  8. Sleep Condition Indicator

    Time frame: Change from baseline to 5 weeks

    Eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria.

  9. The PTSD Checklist for DSM-5 (PCL-5)

    Time frame: Change from baseline to 5 weeks

    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).

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 20, 2022
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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