NCT04016415|CompletedResultsDMC
Decreasing Stress in Diabetes
De-Stress
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Sponsor study identifier
Secondary identifiers
NIH
interventional
309
1 country
1
Study Start
July 28, 2020
Actual (reported)Primary Completion
August 9, 2024
Actual (reported)Study Completion
August 9, 2024
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 9, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 9, 2019
Actual (reported)July 11, 2019
Actual (reported)July 28, 2020
Actual (reported)August 9, 2024
Actual (reported)August 9, 2024
Actual (reported)October 2, 2025
Actual (reported)Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO)
Home Hemoglobin A1c (HbA1c) was measured and collected using the PTS Diagnostics A1CNow® Self-Check Kit. See Baseline Characteristics section for more details on this outcome measure. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect).
Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 6MO data are reported here as the primary comparison.
Subjects randomized to Mindfulness-Based Stress Reduction (MBSR) will receive the 8-week University of Massachusetts Authorized MBSR curriculum followed by monthly mindfulness boosters in Months 3 to 6. The University of Massachusetts MBSR curriculum was selected for the intervention, as it is the most standardized and researched mindfulness program that has been shown to reduce psychological distress in various patient populations.
Penn State College of Medicine, Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
The study could not be conducted without participant awareness of their randomly assigned course. Course cohorts were variable in size. SME course cohorts were taught by several different instructors throughout the duration of the trial. The COVID-19 pandemic may have impacted participant stress. HbA1c was measured using home kits. Study visits were conducted remotely, and surveys were completed electronically, therefore biasing the study sample towards more technologically capable participants.
Nazia T Raja-Khan, M.D., M.S.
Milton S. Hershey Medical Center
309 participants (actual enrollment reported by the registry).
Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO)
Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 2MO data are reported here as the secondary comparison
Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO)
The DDS was collected during each participant's baseline, 2MO, and 6MO visit and is framed with a recall time frame of the past month. Baseline and 2MO data are reported here as the comparison for this outcome.
Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO)
The DDS was collected during each participant's baseline, 2MO, and 6MO visit and is framed with a recall time frame of the past month. Baseline and 6MO data are reported here as the comparison for this outcome.
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO)
PSS-10 was assessed at screening, baseline (pre-randomization), 2MO, and 6MO visits. Baseline and 2MO data are presented here as the comparison for this outcome.
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO)
PSS-10 was assessed at screening, baseline (pre-randomization), 2MO, and 6MO visits. Baseline and 6MO data are presented here as the comparison for this outcome.
Subjects randomized to Stress Management Education (SME) will receive health education on nutrition (adapted for the type 2 diabetes population), exercise as gentle stretching to match yoga in MBSR, and other general health topics that may be relevant to the type 2 diabetes population such as sleep, time management, etc. Stress Management Education does not have any mindfulness in it. Stress Management Education was specifically created as a control condition for MBSR studies so it matches MBSR for time, social support, homework, etc.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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First Submitted
July 9, 2019
First Posted
July 11, 2019
Study Start
July 28, 2020
Actual (reported)Primary Completion
August 9, 2024
Actual (reported)Study Completion
August 9, 2024
Actual (reported)Last Updated
October 2, 2025
Results First Posted
October 2, 2025
Record last verified: 2025-09
De-identified individual participant data will be available upon request approval beginning one year following the trial's initial publication date. All data requests must be submitted to the Principal Investigator (PI) in the form of a brief proposal outlining the research questions and aims, statistical analysis plan, specific measures needed, funding availability or sponsors involved (if applicable), and any other details pertaining to the proposed project. Proposals will be reviewed by the PI and relevant study team members within 3 months upon receipt.
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Source: ClinicalTrials.gov.
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