Diabetes Mellitus, Type 2 Clinical Trial
— De-StressOfficial title:
Decreasing Stress in Diabetes: A Randomized Controlled Trial
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 control Stress Management Education (SME) on glucose control in adults with uncontrolled type 1 or type 2 diabetes. The study will randomize 290 adults with uncontrolled diabetes to a 6-month MBSR intervention or SME control. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. Outcomes will be assessed at baseline, a follow-up phone call after Class #4, and study visits at 2-months and 6-months.
Status | Recruiting |
Enrollment | 290 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Men and Women 2. Age 18 years or older 3. Diagnosed with diabetes for at least one year 4. Hemoglobin A1c = 7.5% within 10 weeks and 2 days (72 days) before the start of the study intervention (Orientation session) 5. High Subjective stress defined as Perceived Stress Scale-10 score = 12 6. Available for the intervention sessions with reasonable certainty 7. 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 8. Must have a Primary Care Provider (PCP) 9. Must have an accessible/active personal e-mail address or be willing to obtain one for study correspondence Exclusion Criteria: 1. Current suicidality 2. History of, or meets 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. 3. Inpatient admission for psychiatric disorder within the past two years, or ER visit for psychiatric disorder within the past 10 weeks 4. Meets MINI structured interview criteria for Alcohol Use Disorder or Substance Use Disorder (Past 12 months) 5. Inability to read, write or speak English 6. Current enrollment in a stress reduction program, or in any other investigative study 7. Previous participation in a mindfulness-based stress reduction (MBSR) course 8. Pregnant women 9. Have a household member who is currently, or was previously, assigned to study treatment |
Country | Name | City | State |
---|---|---|---|
United States | Penn State College of Medicine, Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center | Georgetown University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Penn State University, Rowan University, West Chester University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Hemoglobin A1c from Baseline to 6 months | Hemoglobin A1c (HbA1c) is a measure of average glucose levels over the past 3 months. | baseline and 6 months | |
Secondary | Change in Hemoglobin A1c from Baseline to 2 months | Hemoglobin A1c (HbA1c) is a measure of average glucose levels over the past 3 months. | baseline and 2 months | |
Secondary | Change in Diabetes Distress Scale from Baseline to 2 months | The Diabetes Distress Scale (DDS) is a 17-item questionnaire that assesses diabetes-related distress on a scale of 1 to 6, where 1 = Not a Problem to 6 = A Very Serious Problem. The lowest possible score is 17 and the highest possible score is 102, indicating living with diabetes is a very serious problem. | baseline and 2 months | |
Secondary | Change in Diabetes Distress Scale from Baseline to 6 months | The Diabetes Distress Scale (DDS) is a 17-item questionnaire that assesses diabetes-related distress on a scale of 1 to 6, where 1 = Not a Problem to 6 = A Very Serious Problem. The lowest possible score is 17 and the highest possible score is 102, indicating living with diabetes is a very serious problem. | baseline and 6 months | |
Secondary | Change in Perceived Stress Scale-10 from Baseline to 2 months | The Perceived Stress Scale-10 (PSS-10) is a 10-item questionnaire that assesses subjective stress on a scale of 0 to 4, where 0 = Never to 4 =Very Often. The lowest possible score is 0 and the highest possible score is 40, indicating high levels of subjective stress. | baseline and 2 months | |
Secondary | Change in Perceived Stress Scale-10 from Baseline to 6 months | The Perceived Stress Scale-10 (PSS-10) is a 10-item questionnaire that assesses subjective stress on a scale of 0 to 4, where 0 = Never to 4 =Very Often. The lowest possible score is 0 and the highest possible score is 40, indicating high levels of subjective stress. | baseline and 6 months |
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