N/A
Completed N=309
Decreasing Stress in Diabetes
Stress · Type 2 Diabetes Mellitus · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT04016415 ↗
Enrolled (actual)
309
Serious AEs
6.9%
Results posted
Oct 2025
Primary outcomePrimary: Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) — 8.50; 8.60; 8.15; 8.24 percentage of glycated hemoglobin — p=0.96
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 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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) |
8.50; 8.60; 8.15; 8.24; -0.35; -0.36 | 0.96 |
| SECONDARY Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) |
8.50; 8.60; 8.27; 8.30; -0.23; -0.30 | 0.68 |
| SECONDARY Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) |
2.48; 2.31; 2.15; 2.05; -0.33; -0.26 | 0.41 |
| SECONDARY Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) |
2.48; 2.31; 2.13; 1.92; -0.34; -0.39 | 0.59 |
| SECONDARY Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) |
19.85; 18.18; 16.65; 16.55; -3.20; -1.63 | 0.04 sig |
| SECONDARY Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) |
19.85; 18.18; 17.04; 16.21; -2.81; -1.98 | 0.30 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04016415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.