Trial Outcomes & Findings for Decreasing Stress in Diabetes (NCT NCT04016415)

Last Updated: 2025-10-02

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

309 participants

Primary outcome timeframe

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.

Results posted on

2025-10-02

Participant Flow

Recruitment from medical clinics, support groups, health fairs, StudyFinder, ResearchMatch, HealthGrades, and social media began 2/26/20 with final participant screened 1/17/24. First consent to study was 7/28/20. Type 2 diabetics were eligible for the study until 7/22/21, then expanding to all diabetics (except gestational diabetes). Eligibility was HbA1c ≥ 8 until 5/9/22, when eligible HbA1c dropped to ≥ 7.5. Final follow-up for primary outcome data collection was on 8/9/24.

497 consents were signed following pre-screening at the start of the initial screening visit, reflecting n=492 unique consented individuals. Study eligibility criteria were assessed further during the screening visit and baseline visit. 183 individuals were consented but never randomized (never enrolled; n=161 ineligible at screening visit, n=1 ineligible at baseline visit, n=14 withdrew from the study, n=1 died, n=6 study team withdraws). 309 (492-183) individuals were enrolled and randomized.

Participant milestones

Participant milestones
Measure	Mindfulness Based Stress Reduction MBSR course (Intervention) - 8-week University of Massachusetts Mindfulness-Based Stress Reduction curriculum adapted for live online delivery due to the Coronavirus Disease 2019 (COVID-19) pandemic; 1 orientation, 6 weekly classes, 1 retreat (long class session), 2 weekly classes, 4 monthly booster sessions; participants are asked to do at least 25-30 minutes of home practice homework per day for 6 days each week for the first 7 weeks following the first class. Home practice homework included mindfulness activities in accordance with the standard MBSR curriculum. Following the last weekly class, participants are encouraged to continue their home practice activities regularly on their own. Examples of MBSR activity engagement includes mindful walking, mindful yoga, mindful eating, and body scans. MBSR does not cover health education. Both arms received the following general information at their baseline visit: Two handouts from the American Diabetes Association Patient Education Library, 1) "Plan Your Portions" Diabetes Placemat and 2) "The Diabetes Advisor - Physical Activity", and three additional handouts covering 3) Hyperglycemia/Hypoglycemia, 4) Glucometer Best Practices, and 5) Blood Glucose Meter Correlation.	Stress Management Education SME course (Active Control) - Dr. Elizabeth Hoge's Stress Management Education program curriculum adapted for live online delivery due to the COVID-19 pandemic; 1 orientation, 6 weekly classes, 1 retreat (long class session), 2 weekly classes, 4 monthly booster sessions; participants are asked to do at least 25-30 minutes of home practice homework per day for 6 days each week for the first 7 weeks after the first class. Home practice homework included listening to excerpts of audiobooks about general stress management or nutrition facts. Following the last weekly class, participants are encouraged to continue their home practice activities regularly on their own. The SME curriculum was specifically created as a control condition for MBSR studies to parallel the intervention's structure with respect to time, schedule, social support, homework, etc. SME does not cover mindfulness. The SME program includes nutrition (adapted for individuals with diabetes), exercise as gentle stretching with Theraband to parallel the yoga component of MBSR, and other general health topics, such as sleep. Both arms received the following general information at their baseline visit: Two handouts from the American Diabetes Association Patient Education Library, 1) "Plan Your Portions" Diabetes Placemat and 2) "The Diabetes Advisor - Physical Activity", and three additional handouts covering 3) Hyperglycemia/Hypoglycemia, 4) Glucometer Best Practices, and 5) Blood Glucose Meter Correlation.
Overall Study STARTED	154	155
Overall Study Attended Orientation (Began Intervention)	147	149
Overall Study Completed a 2-month (2MO) Visit	123	124
Overall Study COMPLETED	115	123
Overall Study NOT COMPLETED	39	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Mindfulness Based Stress Reduction MBSR course (Intervention) - 8-week University of Massachusetts Mindfulness-Based Stress Reduction curriculum adapted for live online delivery due to the Coronavirus Disease 2019 (COVID-19) pandemic; 1 orientation, 6 weekly classes, 1 retreat (long class session), 2 weekly classes, 4 monthly booster sessions; participants are asked to do at least 25-30 minutes of home practice homework per day for 6 days each week for the first 7 weeks following the first class. Home practice homework included mindfulness activities in accordance with the standard MBSR curriculum. Following the last weekly class, participants are encouraged to continue their home practice activities regularly on their own. Examples of MBSR activity engagement includes mindful walking, mindful yoga, mindful eating, and body scans. MBSR does not cover health education. Both arms received the following general information at their baseline visit: Two handouts from the American Diabetes Association Patient Education Library, 1) "Plan Your Portions" Diabetes Placemat and 2) "The Diabetes Advisor - Physical Activity", and three additional handouts covering 3) Hyperglycemia/Hypoglycemia, 4) Glucometer Best Practices, and 5) Blood Glucose Meter Correlation.	Stress Management Education SME course (Active Control) - Dr. Elizabeth Hoge's Stress Management Education program curriculum adapted for live online delivery due to the COVID-19 pandemic; 1 orientation, 6 weekly classes, 1 retreat (long class session), 2 weekly classes, 4 monthly booster sessions; participants are asked to do at least 25-30 minutes of home practice homework per day for 6 days each week for the first 7 weeks after the first class. Home practice homework included listening to excerpts of audiobooks about general stress management or nutrition facts. Following the last weekly class, participants are encouraged to continue their home practice activities regularly on their own. The SME curriculum was specifically created as a control condition for MBSR studies to parallel the intervention's structure with respect to time, schedule, social support, homework, etc. SME does not cover mindfulness. The SME program includes nutrition (adapted for individuals with diabetes), exercise as gentle stretching with Theraband to parallel the yoga component of MBSR, and other general health topics, such as sleep. Both arms received the following general information at their baseline visit: Two handouts from the American Diabetes Association Patient Education Library, 1) "Plan Your Portions" Diabetes Placemat and 2) "The Diabetes Advisor - Physical Activity", and three additional handouts covering 3) Hyperglycemia/Hypoglycemia, 4) Glucometer Best Practices, and 5) Blood Glucose Meter Correlation.
Overall Study Adverse Event	2	1
Overall Study Lost to Follow-up	6	2
Overall Study Physician Decision	5	1
Overall Study Pregnancy	0	1
Overall Study Withdrawal by Subject	24	27
Overall Study Participant Non-Compliance: Orientation not completed prior to Class #2	2	0

Baseline Characteristics

Of the n=154 participants randomized to MBSR arm, n=3 participants were missing pre-randomization values (n=2 protocol deviations - values not recollected at baseline with screening values collected \> 14 days prior; n=1 protocol deviation - no pre-randomization home kit value collected).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness Based Stress Reduction n=154 Participants 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.	Stress Management Education n=155 Participants 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.	Total n=309 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 12.24 • n=154 Participants	53.6 years STANDARD_DEVIATION 11.67 • n=155 Participants	54.6 years STANDARD_DEVIATION 11.98 • n=309 Participants
Sex: Female, Male Female	104 Participants n=154 Participants	102 Participants n=155 Participants	206 Participants n=309 Participants
Sex: Female, Male Male	50 Participants n=154 Participants	53 Participants n=155 Participants	103 Participants n=309 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=154 Participants	15 Participants n=155 Participants	21 Participants n=309 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	147 Participants n=154 Participants	138 Participants n=155 Participants	285 Participants n=309 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=154 Participants	2 Participants n=155 Participants	3 Participants n=309 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=154 Participants	2 Participants n=155 Participants	2 Participants n=309 Participants
Race (NIH/OMB) Asian	3 Participants n=154 Participants	3 Participants n=155 Participants	6 Participants n=309 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=154 Participants	0 Participants n=155 Participants	0 Participants n=309 Participants
Race (NIH/OMB) Black or African American	21 Participants n=154 Participants	19 Participants n=155 Participants	40 Participants n=309 Participants
Race (NIH/OMB) White	125 Participants n=154 Participants	126 Participants n=155 Participants	251 Participants n=309 Participants
Race (NIH/OMB) More than one race	3 Participants n=154 Participants	2 Participants n=155 Participants	5 Participants n=309 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=154 Participants	3 Participants n=155 Participants	5 Participants n=309 Participants
Region of Enrollment United States	154 Participants n=154 Participants	155 Participants n=155 Participants	309 Participants n=309 Participants
Type of Diabetes Type 1	24 Participants n=154 Participants	23 Participants n=155 Participants	47 Participants n=309 Participants
Type of Diabetes Type 2	127 Participants n=154 Participants	128 Participants n=155 Participants	255 Participants n=309 Participants
Type of Diabetes Latent Autoimmune Diabetes in Adults (LADA)	0 Participants n=154 Participants	3 Participants n=155 Participants	3 Participants n=309 Participants
Type of Diabetes Diabetes due to pancreatitis or pancreatectomy (surgical removal of all or part of the pancreas)	2 Participants n=154 Participants	1 Participants n=155 Participants	3 Participants n=309 Participants
Type of Diabetes Drug- or chemical-induced diabetes (such as with steroid use or after organ transplantation)	1 Participants n=154 Participants	0 Participants n=155 Participants	1 Participants n=309 Participants
Randomization Stratification Factor; Taking Insulin at Baseline No	63 Participants n=154 Participants	64 Participants n=155 Participants	127 Participants n=309 Participants
Randomization Stratification Factor; Taking Insulin at Baseline Yes	91 Participants n=154 Participants	91 Participants n=155 Participants	182 Participants n=309 Participants
A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values	8.56 percentage of glycated hemoglobin STANDARD_DEVIATION 1.3 • n=151 Participants • Of the n=154 participants randomized to MBSR arm, n=3 participants were missing pre-randomization values (n=2 protocol deviations - values not recollected at baseline with screening values collected \> 14 days prior; n=1 protocol deviation - no pre-randomization home kit value collected).	8.62 percentage of glycated hemoglobin STANDARD_DEVIATION 1.3 • n=155 Participants • Of the n=154 participants randomized to MBSR arm, n=3 participants were missing pre-randomization values (n=2 protocol deviations - values not recollected at baseline with screening values collected \> 14 days prior; n=1 protocol deviation - no pre-randomization home kit value collected).	8.59 percentage of glycated hemoglobin STANDARD_DEVIATION 1.3 • n=306 Participants • Of the n=154 participants randomized to MBSR arm, n=3 participants were missing pre-randomization values (n=2 protocol deviations - values not recollected at baseline with screening values collected \> 14 days prior; n=1 protocol deviation - no pre-randomization home kit value collected).
Class Cohort Number Cohort 1: Orientation Date = 09/22/2020	4 Participants n=154 Participants	4 Participants n=155 Participants	8 Participants n=309 Participants
Class Cohort Number Cohort 2: Orientation Date = 01/26/2021	4 Participants n=154 Participants	2 Participants n=155 Participants	6 Participants n=309 Participants
Class Cohort Number Cohort 3: Orientation Date = 05/06/2021	2 Participants n=154 Participants	4 Participants n=155 Participants	6 Participants n=309 Participants
Class Cohort Number Cohort 4: Orientation Date = 07/20/2021	6 Participants n=154 Participants	5 Participants n=155 Participants	11 Participants n=309 Participants
Class Cohort Number Cohort 5: Orientation Date = 09/28/2021	7 Participants n=154 Participants	7 Participants n=155 Participants	14 Participants n=309 Participants
Class Cohort Number Cohort 6: Orientation Date = 01/25/2022	8 Participants n=154 Participants	10 Participants n=155 Participants	18 Participants n=309 Participants
Class Cohort Number Cohort 7: Orientation Date = 04/19/2022	10 Participants n=154 Participants	12 Participants n=155 Participants	22 Participants n=309 Participants
Class Cohort Number Cohort 8: Orientation Date = 07/26/2022	11 Participants n=154 Participants	8 Participants n=155 Participants	19 Participants n=309 Participants
Class Cohort Number Cohort 9: Orientation Date = 10/04/2022	9 Participants n=154 Participants	11 Participants n=155 Participants	20 Participants n=309 Participants
Class Cohort Number Cohort 10: Orientation Date = 01/24/2023	19 Participants n=154 Participants	21 Participants n=155 Participants	40 Participants n=309 Participants
Class Cohort Number Cohort 11: Orientation Date = 04/18/2023	24 Participants n=154 Participants	20 Participants n=155 Participants	44 Participants n=309 Participants
Class Cohort Number Cohort 12: Orientation Date = 07/11/2023	16 Participants n=154 Participants	17 Participants n=155 Participants	33 Participants n=309 Participants
Class Cohort Number Cohort 13: Orientation Date = 09/26/2023	18 Participants n=154 Participants	17 Participants n=155 Participants	35 Participants n=309 Participants
Class Cohort Number Cohort 14: Orientation Date = 01/23/2024	16 Participants n=154 Participants	17 Participants n=155 Participants	33 Participants n=309 Participants
Diabetes Distress Scale (DDS) Mean Item Score	2.50 scores on a scale STANDARD_DEVIATION 0.98 • n=154 Participants	2.33 scores on a scale STANDARD_DEVIATION 0.89 • n=155 Participants	2.42 scores on a scale STANDARD_DEVIATION 0.94 • n=309 Participants
Perceived Stress Scale-10 (PSS-10) Score	19.88 scores on a scale STANDARD_DEVIATION 6.66 • n=154 Participants	18.39 scores on a scale STANDARD_DEVIATION 6.69 • n=155 Participants	19.13 scores on a scale STANDARD_DEVIATION 6.71 • n=309 Participants

PRIMARY outcome

Timeframe: 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.

Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=306 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=151; SME=155) and n=237 contributing values to the 6MO timepoint Least Squares Mean (MBSR=114; SME=123).

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction n=154 Participants 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.	Stress Management Education n=155 Participants 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.
Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) 6MO	8.15 percentage of glycated hemoglobin Interval 7.85 to 8.46	8.24 percentage of glycated hemoglobin Interval 7.94 to 8.54
Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) Change from Baseline to 6MO	-0.35 percentage of glycated hemoglobin Interval -0.6 to -0.1	-0.36 percentage of glycated hemoglobin Interval -0.6 to -0.11
Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) Baseline	8.50 percentage of glycated hemoglobin Interval 8.23 to 8.77	8.60 percentage of glycated hemoglobin Interval 8.33 to 8.87

SECONDARY outcome

Timeframe: 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

Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=306 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=151; SME=155) and n=244 contributing values to the 2MO timepoint Least Squares Mean (MBSR=122; SME=122).

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).

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction n=154 Participants 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.	Stress Management Education n=155 Participants 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.
Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) Baseline	8.50 percentage of glycated hemoglobin Interval 8.23 to 8.77	8.60 percentage of glycated hemoglobin Interval 8.33 to 8.87
Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) Change from Baseline to 2MO	-0.23 percentage of glycated hemoglobin Interval -0.46 to -0.01	-0.30 percentage of glycated hemoglobin Interval -0.52 to -0.08
Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) 2MO	8.27 percentage of glycated hemoglobin Interval 7.97 to 8.58	8.30 percentage of glycated hemoglobin Interval 8.0 to 8.61

SECONDARY outcome

Timeframe: 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.

Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=247 contributing values to the 2MO timepoint Least Squares Mean (MBSR=123; SME=124).

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).

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction n=154 Participants 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.	Stress Management Education n=155 Participants 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.
Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) Baseline	2.48 scores on a scale Interval 2.34 to 2.62	2.31 scores on a scale Interval 2.17 to 2.45
Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) Change from Baseline to 2MO	-0.33 scores on a scale Interval -0.43 to -0.22	-0.26 scores on a scale Interval -0.37 to -0.16
Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) 2MO	2.15 scores on a scale Interval 2.02 to 2.29	2.05 scores on a scale Interval 1.91 to 2.18

SECONDARY outcome

Timeframe: 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.

Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=236 contributing values to the 6MO timepoint Least Squares Mean (MBSR=115; SME=121).

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).

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction n=154 Participants 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.	Stress Management Education n=155 Participants 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.
Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) Baseline	2.48 scores on a scale Interval 2.34 to 2.62	2.31 scores on a scale Interval 2.17 to 2.45
Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) Change from Baseline to 6MO	-0.34 scores on a scale Interval -0.47 to -0.22	-0.39 scores on a scale Interval -0.51 to -0.27
Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) 6MO	2.13 scores on a scale Interval 1.99 to 2.27	1.92 scores on a scale Interval 1.78 to 2.06

SECONDARY outcome

Timeframe: 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.

Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=246 contributing values to the 2MO timepoint Least Squares Mean (MBSR=123; SME=123).

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).

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction n=154 Participants 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.	Stress Management Education n=155 Participants 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.
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) Baseline	19.85 scores on a scale Interval 18.61 to 21.09	18.18 scores on a scale Interval 16.95 to 19.41
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) 2MO	16.65 scores on a scale Interval 15.35 to 17.95	16.55 scores on a scale Interval 15.25 to 17.85
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) Change from Baseline to 2MO	-3.20 scores on a scale Interval -4.26 to -2.14	-1.63 scores on a scale Interval -2.69 to -0.58

SECONDARY outcome

Timeframe: 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.

Population: Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=238 contributing values to the 6MO timepoint Least Squares Mean (MBSR=115; SME=123).

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).

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction n=154 Participants 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.	Stress Management Education n=155 Participants 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.
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) Baseline	19.85 scores on a scale Interval 18.61 to 21.09	18.18 scores on a scale Interval 16.95 to 19.41
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) 6MO	17.04 scores on a scale Interval 15.64 to 18.45	16.21 scores on a scale Interval 14.82 to 17.59
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) Change from Baseline to 6MO	-2.81 scores on a scale Interval -3.93 to -1.68	-1.98 scores on a scale Interval -3.07 to -0.88

Adverse Events

Mindfulness Based Stress Reduction

Serious events: 15 serious events

Other events: 43 other events

Deaths: 0 deaths

Stress Management Education

Serious events: 18 serious events

Other events: 46 other events

Deaths: 0 deaths

Consented - Not Randomized

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Mindfulness Based Stress Reduction n=154 participants at risk 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.	Stress Management Education n=155 participants at risk 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.	Consented - Not Randomized n=183 participants at risk Individuals who consented to the trial but were not randomized to a study group arm.
Metabolism and nutrition disorders Hypoglycemia	21.4% 33/154 • Number of events 56 • Adverse event data were collected from consent through end of trial for each individual (up to roughly 6 months after orientation). Adverse events were followed until resolution/stabilization or until end of trial. All Serious Adverse Events (SAEs) are reported here for all consenting individuals. Adverse Events (AEs) were regularly solicited at baseline, 4-wk call, 2MO, and 6MO visits via systematic open-ended check-ins ("Have there been any changes to your health since the last visit?") and questionnaires (e.g. Hypoglycemia Survey) through self-report. Self-initiated reporting of AEs between visits was encouraged. Efforts were made to obtain supporting documentation from medical records as needed.	20.6% 32/155 • Number of events 59 • Adverse event data were collected from consent through end of trial for each individual (up to roughly 6 months after orientation). Adverse events were followed until resolution/stabilization or until end of trial. All Serious Adverse Events (SAEs) are reported here for all consenting individuals. Adverse Events (AEs) were regularly solicited at baseline, 4-wk call, 2MO, and 6MO visits via systematic open-ended check-ins ("Have there been any changes to your health since the last visit?") and questionnaires (e.g. Hypoglycemia Survey) through self-report. Self-initiated reporting of AEs between visits was encouraged. Efforts were made to obtain supporting documentation from medical records as needed.	0.00% 0/183 • Adverse event data were collected from consent through end of trial for each individual (up to roughly 6 months after orientation). Adverse events were followed until resolution/stabilization or until end of trial. All Serious Adverse Events (SAEs) are reported here for all consenting individuals. Adverse Events (AEs) were regularly solicited at baseline, 4-wk call, 2MO, and 6MO visits via systematic open-ended check-ins ("Have there been any changes to your health since the last visit?") and questionnaires (e.g. Hypoglycemia Survey) through self-report. Self-initiated reporting of AEs between visits was encouraged. Efforts were made to obtain supporting documentation from medical records as needed.
Infections and infestations COVID-19	7.8% 12/154 • Number of events 12 • Adverse event data were collected from consent through end of trial for each individual (up to roughly 6 months after orientation). Adverse events were followed until resolution/stabilization or until end of trial. All Serious Adverse Events (SAEs) are reported here for all consenting individuals. Adverse Events (AEs) were regularly solicited at baseline, 4-wk call, 2MO, and 6MO visits via systematic open-ended check-ins ("Have there been any changes to your health since the last visit?") and questionnaires (e.g. Hypoglycemia Survey) through self-report. Self-initiated reporting of AEs between visits was encouraged. Efforts were made to obtain supporting documentation from medical records as needed.	11.0% 17/155 • Number of events 17 • Adverse event data were collected from consent through end of trial for each individual (up to roughly 6 months after orientation). Adverse events were followed until resolution/stabilization or until end of trial. All Serious Adverse Events (SAEs) are reported here for all consenting individuals. Adverse Events (AEs) were regularly solicited at baseline, 4-wk call, 2MO, and 6MO visits via systematic open-ended check-ins ("Have there been any changes to your health since the last visit?") and questionnaires (e.g. Hypoglycemia Survey) through self-report. Self-initiated reporting of AEs between visits was encouraged. Efforts were made to obtain supporting documentation from medical records as needed.	0.00% 0/183 • Adverse event data were collected from consent through end of trial for each individual (up to roughly 6 months after orientation). Adverse events were followed until resolution/stabilization or until end of trial. All Serious Adverse Events (SAEs) are reported here for all consenting individuals. Adverse Events (AEs) were regularly solicited at baseline, 4-wk call, 2MO, and 6MO visits via systematic open-ended check-ins ("Have there been any changes to your health since the last visit?") and questionnaires (e.g. Hypoglycemia Survey) through self-report. Self-initiated reporting of AEs between visits was encouraged. Efforts were made to obtain supporting documentation from medical records as needed.

Additional Information

Dr. Nazia T Raja-Khan, M.D., M.S., Associate Prof, Dept of Medicine, Div. of Endocrin & Diabetes

Milton S. Hershey Medical Center, Penn State Hershey College of Medicine

Phone: 717-531-8395

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place