Decreasing Stress in Diabetes (De-Stress)

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 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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Stress
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction; Behavioral: Stress Management Education

Detailed Description

Specific Aims are: 1) To conduct a randomized controlled trial 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 levels in at least 290 adults with uncontrolled type 1 or type 2 diabetes. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. The primary outcome will be hemoglobin A1c (HbA1c), a measure of the average glucose level over the past 3 months. We hypothesize that between the two groups, there will be a clinically significant 0.5% absolute difference in the mean change in HbA1c from baseline to 6-months. We will also look at the 2-month HbA1c, however it may be too brief a time period to fully capture the impact of MBSR. An absolute reduction in HbA1c of 0.5% would be expected to reduce the risk of any diabetes-related complication by at least 10%. Additionally, we will assess fasting glucose as a secondary outcome as it is linked with adverse health outcomes, and can be lowered with MBSR based on our pilot study; 2) To determine the effects of online MBSR compared to SME control on psychosocial, behavioral and physiological mechanisms potentially mediating the effects of MBSR and/or SME on glucose levels in adults with uncontrolled diabetes. Secondary outcomes include: diabetes-related distress, subjective stress, craving, the impact of Coronavirus Disease 2019 (COVID-19) on subjects' lives, subject expectancy, dietary intake, physical activity, and serum hsCRP as a marker of chronic inflammation. Adverse Childhood Experiences (ACEs) will be assessed at baseline. It is hypothesized that these measures may mediate the effects of MBSR and/or SME on glucose.

The proposed study has the potential to transform current standards of care for diabetes by using a novel long-term MBSR intervention as a powerful adjunct intervention for diabetes. MBSR could impact the clinical picture of diabetes by empowering patients with skills for strengthening their own internal resources to promote self regulation and adaptive coping and reduce stress reactivity, which are all essential for implementing healthy behaviors and are expected to lead to improved glucose control and reduced risk of diabetes complications. This proposal is relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to conduct research on diabetes to improve people's health and quality of life.

• Study Type: Interventional
• Enrollment (Actual): 309
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine, Penn State Milton S Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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.
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stress Management Education	Behavioral: Stress Management Education; 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.
Experimental: Mindfulness Based Stress Reduction	Behavioral: Mindfulness Based Stress Reduction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO)	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 2MO 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 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 Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 ("not a problem") to 6 ("a very serious problem"), with higher scores indicating more diabetes-related distress. The DDS Mean Item score is calculated as the average of all 17 items on the scale. 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 2MO from this model (where all three study visit timepoints are included in the time effect).	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 Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 ("not a problem") to 6 ("a very serious problem"), with higher scores indicating more diabetes-related distress. The DDS Mean Item score is calculated as the average of all 17 items on the scale. 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).	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 is a 10-item survey that includes both positive and negative phrased items on a scale of 0-4. After reversing 4 positive items, the summative score ranges from 0-40, where higher values indicate higher levels of perceived stress, with a recall time frame for the last month. 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 2MO from this model (where all three study visit timepoints are included in the time effect).	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 is a 10-item survey that includes both positive and negative phrased items on a scale of 0-4. After reversing 4 positive items, the summative score ranges from 0-40, where higher values indicate higher levels of perceived stress, with a recall time frame for the last month. 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).	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.

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Georgetown University; National Institutes of Health (NIH); Rowan University; West Chester University of Pennsylvania
• Investigators: Principal Investigator: Nazia T Raja-Khan, M.D., M.S., Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): August 9, 2024
• Study Completion (Actual): August 9, 2024

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 13, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; Meditation; Stress, Psychological; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Mind-Body Therapies
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Stress, Psychological; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Stress Reduction
• Other Study ID Numbers: 10532 (DAIDS ES); 5R01DK119379 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Proposals will be reviewed and considered for approval beginning one year following the trial's initial publication date
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No