Status:
COMPLETED
Decreasing Stress in Diabetes
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Conditions:
Stress
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to conduct a randomized controlled trial (RCT) to determine the effects of an online 6-month Mindfulness-based stress reduction (MBSR) intervention compared to an active c...
Detailed Description
Specific Aims are: 1) To conduct a randomized controlled trial to determine the effects of an online 6-month Mindfulness-Based Stress Reduction (MBSR) intervention compared to an active control Stress...
Eligibility Criteria
Inclusion
- Men and Women
- Age 18 years or older
- Diagnosed with diabetes for at least one year
- Hemoglobin A1c ≥ 7.5% within 10 weeks and 2 days (72 days) before the start of the study intervention (Orientation session)
- High Subjective stress defined as Perceived Stress Scale-10 score ≥ 12
- Available for the intervention sessions with reasonable certainty
- Have a device equipped with internet connection, camera and microphone and willingness to interact with study staff and class instructors virtually/remotely via this platform
- Must have a Primary Care Provider (PCP)
- Must have an accessible/active personal e-mail address or be willing to obtain one for study correspondence
Exclusion
- Current suicidality
- History of, or meets Mini International Neuropsychiatric Interview (MINI) structured interview criteria for, bipolar disorder, psychosis, or other significant psychopathology; Those with depression or anxiety will be allowed to participate since they are under the care of a PCP.
- Inpatient admission for psychiatric disorder within the past two years, or ER visit for psychiatric disorder within the past 10 weeks
- Meets MINI structured interview criteria for Alcohol Use Disorder or Substance Use Disorder (Past 12 months)
- Inability to read, write or speak English
- Current enrollment in a stress reduction program, or in any other investigative study
- Previous participation in a mindfulness-based stress reduction (MBSR) course
- Pregnant women
- Have a household member who is currently, or was previously, assigned to study treatment
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2024
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT04016415
Start Date
July 28 2020
End Date
August 9 2024
Last Update
October 2 2025
Active Locations (1)
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1
Penn State College of Medicine, Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033