NCT05208164 · University of Illinois at Chicago
My ESSENCE - A Research Study on Mindfulness for African-Americans With Type 2 Diabetes
(E-RCT)
What this study is about
The proposed research and training will allow Dr. Alana Biggers to obtain critical research skills and study a mindfulness meditation program designed to improve sleep and reduce stress in African-American adults with diabetes. If effective, this program may reduce the risk of cardiovascular disease among African-Americans with type 2 diabetes who are at high risk of cardiovascular disease.
View original scientific description
The proposed research and training will allow Dr. Alana Biggers to obtain critical research skills and study a mindfulness meditation program designed to improve sleep and reduce stress in African-American adults with diabetes. If effective, this program may reduce the risk of cardiovascular disease among African-Americans with type 2 diabetes who are at high risk of cardiovascular disease.
Interventions
BEHAVIORAL
Mindfunlness Meditation
Sleep monitoring, mental health promotion and active enrollment/engagement in self-described coping mechanisms
Primary outcome measures
Sleep Quality
Time frame: Change from baseline at 8 and 16 weeks.
Will use Pittsburgh Sleep Quality Index (PSQI). PSQI has a minimum score of 0 (better) and maximum of 21 (worse). Score \> 5 is considered poor quality sleep.
Perceived Stress
Time frame: Change from baseline at 8 and 16 weeks.
Will use Perceived Stress Scale. Scale has a minimum value of 0, and maximum value of 40. Scores from 0-13 are considered low stress, 14-26 are moderate, and 27-40 are high perceived stress.
Sleep Disturbances
Time frame: Change from baseline at 8 and 16 weeks
Will use Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8b. Scores are reported as T-scores, with 28.9 being the minimum value, and 76.5 being the maximum. Higher scores indicate greater sleep disturbances.
Sleep Impairment
Time frame: Change from baseline at 8 and 16 weeks
Will use Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short Form 8a.Scores are reported as T-scores, with 30.0 being the minimum value, and 80.1 being the maximum. Higher scores indicate greater sleep impairment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Self-identifies as African American or Black
- Diagnosis of type 2 diabetes
- Valid address in greater Chicagoland area
- Mobile phone with unlimited text-messaging
- Mobile device (smartphone, tablet, or computer) with the ability to connect to the internet if remote online delivery
- Availability to participate in mindfulness class either in-person or online
Exclusion criteria
- Untreated obstructive sleep apnea (OSA)
- Severe insomnia, narcolepsy, or REM sleep related disorder
- Major cognitive impairments or psychiatric disorder
- Alcohol or drug abuse
- Limited English proficiency
- Inability to send/receive text messages
- Currently engaging in mindfulness practice
Where
- Chicago, Illinois
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2025 · Source of record for eligibility and locations