Project MiCRIM- Sleep and Stress Intervention

NCT05384067 | Completed

• 1 other identifier: STUDY00002715
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Stress

Keywords

mindfulness; sleep; stress

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline to 5 weeks

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

  Change from baseline to 5 weeks

• The Smith Relaxation Dispositions Inventory

  Change from baseline to 5 weeks

• Five Facet Mindfulness Questionnaire - Short Form

  Change from baseline to 5 weeks

• Patient Health Questionnaire 9

  Change from baseline to 5 weeks

Study Arms (2)

Mindfulness-based intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in this arm will only wear a sleep-monitoring device and complete questionnaires.

Interventions

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.

Mindfulness-based intervention

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Criminal Justice or Criminology major

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University Center for Translational Behavioral Medicine

Tallahassee, Florida, 32310, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention and control group

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 20, 2022
• Study Start: May 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)