Decreasing Stress in Diabetes
De-Stress
2 other identifiers
interventional
309
1 country
1
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedStudy Start
First participant enrolled
July 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2024
CompletedResults Posted
Study results publicly available
October 2, 2025
CompletedOctober 2, 2025
September 1, 2025
4 years
July 9, 2019
August 6, 2025
September 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (5)
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.
Study Arms (2)
Mindfulness Based Stress Reduction
EXPERIMENTALStress Management Education
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milton S. Hershey Medical Centerlead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- National Institutes of Health (NIH)collaborator
- Rowan Universitycollaborator
- West Chester University of Pennsylvaniacollaborator
- Georgetown Universitycollaborator
Study Sites (1)
Penn State College of Medicine, Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Nazia T Raja-Khan, M.D., M.S., Associate Prof, Dept of Medicine, Div. of Endocrin & Diabetes
- Organization
- Milton S. Hershey Medical Center, Penn State Hershey College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Nazia T Raja-Khan, M.D., M.S.
Milton S. Hershey Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The PI, study coordinator, and all study personnel collecting outcomes, will be blinded from the treatment assignments. Only the MBSR and SME instructors and the study personnel who schedule the classes, videorecord the classes, and code the videos will have knowledge of the assignments, and these individuals will not be involved in the collection of outcomes. Subjects will be asked to keep their treatment assignment concealed from study personnel collecting outcomes. However, complete blinding may not be possible given the nature of this study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine, Obstetrics and Gynecology, and Psychiatry and Behavioral Health
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 11, 2019
Study Start
July 28, 2020
Primary Completion
August 9, 2024
Study Completion
August 9, 2024
Last Updated
October 2, 2025
Results First Posted
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Proposals will be reviewed and considered for approval beginning one year following the trial's initial publication date
- Access Criteria
- For data request proposals that receive approval, consultations will be scheduled to coordinate any relevant or applicable Institutional Review Board (IRB) considerations and/or data use agreements pertaining to the specific data requested.
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.