SleepNCT05384067
Project MiCRIM- Sleep and Stress Intervention
A study testing Mindfulness-based intervention in people with Sleep and Stress, run by Florida State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- What is being tested?
- Mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Criminal Justice or Criminology major
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University Center for Translational Behavioral Medicine
Tallahassee, Florida, 32310
About this study
Official title: Defining Stress and Sleep as Modifiable Intervention Targets in Correctional Officers to Reduce Mental and Physical Health Risk
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.
Read the 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.
- Being tested
- Mindfulness-based intervention
- Keywords
- mindfulness, sleep, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-based intervention |
| Control | No intervention | Participants in this arm will only wear a sleep-monitoring device and complete questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva Samples via ELISA Assay- Cortisol
Tests for level changes in cortisol.
Measured: Change from baseline to 5 weeks
Saliva Samples via ELISA Assay- α-amylase
Test for level changes in α-amylase.
Measured: Change from baseline to 5 weeks
Saliva Samples via ELISA Assay- interleukin-1beta
Test for level changes in interleukin-1beta.
Measured: Change from baseline to 5 weeks
Saliva Samples via ELISA Assay- interleukin-6
Test for level changes in interleukin-6.
Measured: Change from baseline to 5 weeks
Saliva Samples via ELISA Assay- interleukin-8
Test for level changes in interleukin-8.
Measured: Change from baseline to 5 weeks
Saliva Samples via ELISA Assay- TNF-α
Test for level changes in TNF-α.
Measured: Change from baseline to 5 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Change from baseline to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 May 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and control group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Pickett, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384067
- Sponsor's protocol ID
- STUDY00002715
- Status last verified
- Jul 2023
- First submitted
- 12 May 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Stress and Sleep as Modifiable Intervention Targets in Correctional Officers to Reduce Mental and Physical Health Risk
- ClinicalTrials.gov ID
- NCT05384067
- Acronym / sponsor ID
- STUDY00002715
- Keywords
- mindfulness, sleep, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention | Experimental | Behavioral: Mindfulness-based interventionParticipants 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. |
| Control | No intervention | –Participants in this arm will only wear a sleep-monitoring device and complete questionnaires. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Criminal Justice or Criminology major
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based interventionParticipants 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. | Behavioural | Mindfulness-based intervention |
Primary outcome
Saliva Samples via ELISA Assay- Cortisol
Time frame: Change from baseline to 5 weeks
Tests for level changes in cortisol.
Saliva Samples via ELISA Assay- α-amylase
Time frame: Change from baseline to 5 weeks
Test for level changes in α-amylase.
Saliva Samples via ELISA Assay- interleukin-1beta
Time frame: Change from baseline to 5 weeks
Test for level changes in interleukin-1beta.
Saliva Samples via ELISA Assay- interleukin-6
Time frame: Change from baseline to 5 weeks
Test for level changes in interleukin-6.
Saliva Samples via ELISA Assay- interleukin-8
Time frame: Change from baseline to 5 weeks
Test for level changes in interleukin-8.
Saliva Samples via ELISA Assay- TNF-α
Time frame: Change from baseline to 5 weeks
Test for level changes in TNF-α.
9 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline to 5 weeks
Pittsburgh Sleep Quality Index, Addendum for PTSD (PSQI-A)
Time frame: Change from baseline to 5 weeks
The Smith Relaxation Dispositions Inventory
Time frame: Change from baseline to 5 weeks
Five Facet Mindfulness Questionnaire - Short Form
Time frame: Change from baseline to 5 weeks
Patient Health Questionnaire 9
Time frame: Change from baseline to 5 weeks
Generalized Anxiety Disorder 7
Time frame: Change from baseline to 5 weeks
Perceived Stress Scale
Time frame: Change from baseline to 5 weeks
Sleep Condition Indicator
Time frame: Change from baseline to 5 weeks
The PTSD Checklist for DSM-5 (PCL-5)
Time frame: Change from baseline to 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention in people with Sleep and Stress, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva Samples via ELISA Assay- Cortisol (time frame: Change from baseline to 5 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023; AzTrials last refreshed its copy on 30 Oct 2026.