NCT04016415Completed
Decreasing Stress in Diabetes
Decreasing Stress in Diabetes: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Oct 2025
Brief summary (registry, in English)
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 at least 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 (2MO) and 6-months (6MO).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 309 (actual)
- First submitted
- 9 Jul 2019
- Start date
- 28 Jul 2020
- Primary completion date
- 9 Aug 2024
- Lead sponsor
- Milton S. Hershey Medical Center
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT04016415
What you commit to
- Study type: Interventional
- Participants enrolled: 309
- From 28 Jul 2020 to the primary completion date, 9 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in a mindfulness-based stress reduction (MBSR) course
- Have a household member who is currently, or was previously, assigned to study treatment
Other illness
- 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)
Other
- Current suicidality
- Inability to read, write or speak English
- Current enrollment in a stress reduction program, or in any other investigative study
- Pregnant women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.