Project MiCRIM- Sleep and Stress Intervention

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05384067
• Other study ID #: STUDY00002715
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep
• Stress

Intervention

Behavioral:
• Mindfulness-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.

Locations

Country	Name	City	State
United States	Florida State University Center for Translational Behavioral Medicine	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saliva Samples via ELISA Assay- Cortisol	Tests for level changes in cortisol.	Change from baseline to 5 weeks
Primary	Saliva Samples via ELISA Assay- a-amylase	Test for level changes in a-amylase.	Change from baseline to 5 weeks
Primary	Saliva Samples via ELISA Assay- interleukin-1beta	Test for level changes in interleukin-1beta.	Change from baseline to 5 weeks
Primary	Saliva Samples via ELISA Assay- interleukin-6	Test for level changes in interleukin-6.	Change from baseline to 5 weeks
Primary	Saliva Samples via ELISA Assay- interleukin-8	Test for level changes in interleukin-8.	Change from baseline to 5 weeks
Primary	Saliva Samples via ELISA Assay- TNF-a	Test for level changes in TNF-a.	Change from baseline to 5 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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