Mind-STRIDE: Mindful Stress Reduction in Diabetes Self-management Education for Veterans

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02928952
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Arms: 2
• Actual Duration (Months): 41.2
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The purpose of this study is to see if adding Mindfulness training to diabetes education reduces feelings of stress and makes it easier to adhere to healthy behaviors that improve diabetes outcomes (such as hemoglobin A1c).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Behavioral: Mind-STRIDE	N/A

Detailed Description

Background: One million Veterans (25%) who receive health care through Veterans Health Administration (VHA) have diabetes and are therefore responsible for daily diabetes self-management (DSM). DSM is essential for glycemic control and prevention of potentially life threatening and disabling complications such as severe hypoglycemia, kidney failure, acute coronary syndrome and stroke. Importantly, 40% of individuals with diabetes suffer from diabetes-related distress (DRD) that interferes with their ability to sustain healthy self-management behaviors, and may be particularly problematic for Veterans who are at higher risk for comorbid negative emotional states such as depression and post-traumatic stress disorder.

Diabetes self-management education (DSME) has traditionally contained little content or skill-building directly related to stress management, leaving this critical component of diabetes self-management largely unaddressed in DSME. In the investigators' pilot work, the investigators have developed a brief stress management intervention known as Mind-STRIDE, which contains mindfulness training and home practice and is easily integrated into existing DSME. While the investigators have previously demonstrated the feasibility, patient acceptability, and initial efficacy of Mind-STRIDE, its effects on diabetes-related psychological and physiological patient outcomes remain unknown. There is, therefore, a critical need to determine the efficacy of this targeted mindfulness intervention for improving DRD, diabetes self-efficacy, DSM behaviors, and metabolic control of Veterans with diabetes in order to offer comprehensive, evidence-based DSME that improves Veteran-centric diabetes outcomes.

Objectives: The objectives of this study are to determine the efficacy of Mind-STRIDE for improving DRD, diabetes self-efficacy, DSM, and metabolic control, and to characterize distinctive Veteran experiences with DRD and Mind-STRIDE.

Methods: To achieve these objectives, the investigators will conduct a randomized controlled trial of 126 Veterans at a large VA medical center in southwest PA. Participants will be assigned to one of two study conditions: an experimental group that receives routine diabetes education plus Mind-STRIDE, or to a usual care group that receives diabetes education alone. DRD, diabetes self-efficacy, and DSM will be assessed using self-report questionnaires. Metabolic control (Hemoglobin A1c) will be assessed using standard laboratory procedures. Data will be collected at baseline, 12-weeks, and 24-weeks, and will be analyzed using mixed-effects models. Telephone interviews will be conducted at 15-weeks post-intervention in a subset of participants from the experimental group, and will be analyzed using modified Grounded Theory methods. Quantitative and qualitative findings will be compared and interpreted using Convergent Parallel Design.

Status: Assessments were completed 4/09/2020.

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Effects of a Mindfulness Intervention Delivered Within Diabetes Education on Diabetes-related Outcomes in Military Veterans
• Actual Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Apr 9, 2020
• Actual Study Completion Date: Apr 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diabetes Self Management Education (DSME) + Mind-STRIDE Will receive routine diabetes self-management education + the Mind-STRIDE intervention	Behavioral: Mind-STRIDE; Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education
No Intervention: DSME alone Usual care control

Outcome Measures

Primary Outcome Measures

1. Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress) [baseline, 12 weeks and 24 weeks]

   A 20-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores are summed and multiplied by 1.25. Minimum value = 0; Maximum value = 100. Higher scores denote higher levels of diabetes related distress. The cutoff for significant distress is 33; a score of 40 is consistent with diabetes burn-out.

Secondary Outcome Measures

1. Diabetes Self-efficacy Scale (DSES) [baseline, 12 weeks and 24 weeks]

   An 8-item psychometrically validated self-report questionnaire on a 10- point Likert Scale (1= Not confident at all; 10 = Totally confident). This scale measures diabetes self efficacy, a critical pathway to improved self-management that refers to an individual's confidence in their ability to perform key diabetes self-management behaviors. Scores are derived as the mean of the 8 questions. Minimum score =1; Maximum Score = 10. Higher scores denote higher diabetes self-efficacy.

2. Hemoglobin A1c (A1C) [baseline, 12 weeks and 24 weeks]

   A blood test that measures the percentage of glycated hemoglobin in red blood cells as a means of estimating the average blood sugar concentrations for the preceding two to three months. Lower percentage denote better blood glucose levels and may range from 4.5% in persons without diabetes t0 >15% in persons with poorly managed hyperglycemia. . An A1C <7% has been associated with prevention of diabetes complications. A1C>9% denotes chronic,severe blood glucose elevation. All tests were performed at VAPHS according to National Glyco-hemoglobin Standardization Program-approved methods.

3. Mindfulness Attention and Awareness Scale (MAAS) [baseline, 12 weeks and 24 weeks]

   A 15-item psychometrically validated questionnaire on a 6-point Likert scale (1=Almost Always and 6= Never) The scale is scored by computing the mean of the 15 items. (Minimum score = 1; maximum score = 6). Higher scores reflect higher levels of dispositional (trait) mindfulness. Average score in the general US population is 4.22. Mindfulness is a mental state achieved by focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations.

4. Body Weight [baseline, 12 weeks and 24 weeks]

   Weight in pounds

5. Blood Pressure [baseline, 12 weeks and 24 weeks]

   Change in mean arterial blood pressure, calculated as blood pressure + 2 (diastolic blood pressure) divided by 3.

6. Patient Health Questionnaire (PHQ8) [baseline, 12 weeks and 24 weeks]

   The Patient Health Questionnaire (PHQ-8) is a standardized, validated scale that assesses 8 key symptoms of depression experienced over the prior two weeks on a 4-point Likert scale (0=not at all; 3= nearly every day). It is the same as the PHQ-9, without the question regarding suicidal ideation. Score is the sum of the 8 items (Minimum value =0; Maximum= 24). A score of 10 or greater is considered major depression, 20 or more is severe major depression.

7. PTSD Checklist- Civilian Version (PCL-C) [baseline, 12 weeks and 24 weeks]

   The Abbreviated PCL-C is a validated 6-item civilian version of the PTSD check- list designed for use in general medical settings to assess symptoms of PTSD using a 5-point Likert scale. Scores reflect how much the participant has been bothered by specific PTSD symptoms during the past month. (0= "not at all; 4= "extremely") .Scores are summed. (Minimum value =0; maximum values = 24). Scores >14 are suggestive of PTSD, with higher scores reflecting greater PTSD symptoms.

8. Summary of Diabetes Self-Care Activities (SDSCA), General Diet [baseline, 12 weeks and 24 weeks]

   A 2-item subscale of the psychometrically validated SDSCA that measures the frequency of general dietary behaviors each day over the past 7-days and number of days per week over the past month (0= no days; 7 = 7 days). Scores = mean number of days per week ( Minimum score =0; maximum score = 7) . Higher scores denote healthier dietary behaviors.

9. Summary of Diabetes Self-Care Activities (SDSCA), Specific Diet [baseline, 12 weeks and 24 weeks]

   A 2-item subscale of the psychometrically validated SDSCA that measures the frequency of eating fruits and vegetables and high fat foods each day over the past 7-days. Minimum maximum values = (0= no days; 7 = 7 days). 1 item is scored as mean number of days (Minimum score =0; maximum score = 7), while the 2nd item is summed and reversed (0= 7days; 7= 0 days). The scores for the two items are summed for the subscale score (Minimum score=0; maximum score =7) Higher scores denote healthier dietary behaviors. Each subscale of the SDSCA is scored separately, without a calculated composite score.

10. Summary of Diabetes Self-Care Activities (SDSCA) Space Carbohydrates [baseline, 12 weeks and 24 weeks]

    One item from the SDSCA that assesses the number of days over the past 7-days in which the participant spaced carbohydrates evenly throughout the day. Minimum score 0; maximum score 7. Higher scores denote healthier dietary behaviors.

11. Summary of Diabetes Self-Care Activities (SDSCA)- Exercise [baseline, 12 weeks, 24 weeks]

    A 2-item subscale of the SDSCA that measures the number of days over the past 7-days on which the participant engaged in physical activity . Score = mean score of days over the past 7 days (Min.=1; Max.=7). Higher scores denote healthier exercise behaviors. Each SDSCA subscale scored separately.

12. Summary of Diabetes Self-Care Activities (SDSCA)- - Footcare [baseline, 12 weeks, 24 weeks]

    A 2-item subscale of the SDSCA that measures the number of days the participant 1) inspected their feet and 2) inspected the inside of their shoes over the past 7-days. Score = mean number of days (Min=0; max=7). Higher scores denote healthier footcare behaviors.

13. Summary of Diabetes Self-Care Activities (SDSCA)- Blood Glucose Testing [baseline, 12 weeks, 24 weeks]

    A 2-item subscale of the SDSCA that measures 1) the number of days on which the participant tested their blood glucose over the past 7 days and 2) the number of days on which they tested their blood glucose according to the number of times recommended by their health care provider over the past 7-days. Scores= mean number of days per week. Minimum score is 0 Maximum score is 7.Higher scores denote healthier self-monitoring behaviors. Each SDSCA subscale scored separately

14. Summary of Diabetes Self-Care Activities (SDSCA)- - Smoking [baseline,12 weeks, 24 weeks]

    A 2-item subscale of the SDSCA that measures 1) whether the participant smoked even a puff of a cigarette in the past 7 days (0=no; 1= yes) and 2) if so, the number of cigarettes smoked on an average day. The scores are summed. Minimum score =0, maximum score = >40. Lower scores denote healthier smoking behaviors.

15. Summary of Diabetes Self-Care Activities (SDSCA)- - Medication Adherence [baseline, 12 weeks, 24 weeks]

    A 2-item subscale of the SDCSA that measures the frequency of 1) taking prescribed insulin and 2)prescribed number of diabetes pills each day over the past 7-days. Scores from the 2 items are summed. Minimum score =0; maximum score = 7). Higher scores denote greater adherence to diabetes medications. Participants entered N/A if they were not prescribed insulin or diabetes pills. Each subscale of the SDSCA is scored independently with no calculated composite score.

Other Outcome Measures

1. Change in 6-item PROMIS Short Form v1.0 Pain Interference 6 b [baseline, 12 weeks and 24 weeks]

   A psychometrically validated 7-item instrument on a 5 point Likert scale (1= "not at all"- 5 and "very much") determining the degree to which pain has interfered with aspects of daily living during the past 7 days. It is a general and not disease-specific measure of pain. Scores are summed (Min. value = 6; Max value =35). Total raw scores are then converted into a T-score for each participant. The T-scores rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A score of 50 is the average for the United States general population with a standard deviation of 10.

2. Insomnia Severity Index (ISI) [baseline, 12 weeks and 24 weeks]

   Seven psychometrically tested items on a 4 point Likert scale that measure difficulty falling asleep and staying asleep (0= none; 4=very severe) and satisfaction with current sleep patterns (0=very satisfied; 4=very dissatisfied), Noticeable impairment of quality of life (0= not noticeable; 4= very much noticeable), Worry/distress re: sleep (0=not at all worried; 4=very much worried); Interference of sleep problem to daily functioning (0=not interfering; 4= very much interfering). Scores are summed. Minimum score = 0; maximum score = 20). Higher scores denote greater insomnia severity. Scores over 14 denote insomnia; Scores 8 to 14 denote subthreshold insomnia.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Referral to DSME class at VA Pittsburgh Healthcare System University Drive Campus (VAPHS UD)

• Diagnosis of type 1 or type 2 diabetes

• Hemoglobin A1C >7.0%

• Problem Areas in "Diabetes Scale (PAID) -5" score =/ >3 or "Diabetes Distress Scale -2" =/>2 score indicating the presence of Diabetes-related Distress

Exclusion Criteria:

• Documented cognitive impairment that would interfere with the ability to comprehend the informed consent and actively participate in the study

• Previous attendance of VA DSME class within the past 12 months

• Currently active mindfulness practice

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania	United States	15240

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Monica M. DiNardo, PhD ARNP CDE, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 2, 2015

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02928952
• Other Study ID Numbers: NRI 15-150
• First Posted: Oct 10, 2016
• Last Update Posted: May 28, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Mindfulness; Diabetes Distress
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

Participant Flow

Recruitment Details	Dates of recruitment: 11-1-2016 to 10-31-2019 Diabetes outpatient clinic at VA Pittsburgh Healthcare System, Oakland campus
Pre-assignment Detail	One participant was excluded because of concomitant enrollment in a similar study that could have confounded results.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Period Title: Overall Study
STARTED	65	67
COMPLETED	55	60
NOT COMPLETED	10	7

Baseline Characteristics

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone	Total
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control	Total of all reporting groups
Overall Participants	65	67	132
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.6 (10.5)	60.7 (10.8)	60.7 (10.6)
Sex: Female, Male (Count of Participants)
Female	5 7.7%	6 9%	11 8.3%
Male	60 92.3%	61 91%	121 91.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	20 30.8%	23 34.3%	43 32.6%
White	45 69.2%	44 65.7%	89 67.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	65 100%	67 100%	132 100%
Living with partner (Count of Participants)
Count of Participants [Participants]	26 40%	31 46.3%	57 43.2%
Post-High School Education (Count of Participants)
Count of Participants [Participants]	54 83.1%	52 77.6%	106 80.3%
Employment Status- working full or part time (Count of Participants)
Count of Participants [Participants]	18 27.7%	14 20.9%	32 24.2%
Diabetes Phenotype-type 2 diabetes (Count of Participants)
Count of Participants [Participants]	62 95.4%	62 92.5%	124 93.9%
Charlson Co-Morbidity Index (CMI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.31 (141)	4.33 (1.79)	4.32 (1.61)
Insulin use (Count of Participants)
Count of Participants [Participants]	46 70.8%	47 70.1%	93 70.5%
Duration of Diabetes (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.09 (9.67)	13.81 (11.05)	12.96 (10.39)

Outcome Measures

1. Primary Outcome

Title	Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress)
Description	A 20-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores are summed and multiplied by 1.25. Minimum value = 0; Maximum value = 100. Higher scores denote higher levels of diabetes related distress. The cutoff for significant distress is 33; a score of 40 is consistent with diabetes burn-out.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Numbers analyzed differ among rows from the overall number analyzed because of attrition and missed visits.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	27.58 (15.41)	31.24 (16.72)
12 weeks	17.00 (13.10)	20.83 (13.32)
24 weeks	12.89 (11.30)	21.15 (13.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.153
	Comments
	Method	Mixed Models Analysis
	Comments	All models adjusted for Age and Duration of Diabetes

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments
	Type of Statistical Test	Superiority
	Comments	Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.026
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for age and duration of diabetes.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	Within group analysis of intervention effect on Diabetes Distress (Problem Areas in Diabetes, PAID scale) over time stratified by hemoglobin A1c<8.5% and =/>8.5.
	Type of Statistical Test	Superiority
	Comments	Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	Mixed Models Analysis
	Comments	Models adjusted for age and duration of diabetes.

2. Secondary Outcome

Title	Diabetes Self-efficacy Scale (DSES)
Description	An 8-item psychometrically validated self-report questionnaire on a 10- point Likert Scale (1= Not confident at all; 10 = Totally confident). This scale measures diabetes self efficacy, a critical pathway to improved self-management that refers to an individual's confidence in their ability to perform key diabetes self-management behaviors. Scores are derived as the mean of the 8 questions. Minimum score =1; Maximum Score = 10. Higher scores denote higher diabetes self-efficacy.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Statistical Test of hypothesis. Differing sample sizes are due to attrition and missed research visits. Analyzed as intention to treat in mixed models with imputation as last value moved forward.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	6.20 (1.94)	5.77 (1.95)
12 weeks	6.97 (1.91)	6.40 (1.80)
24 weeks	7.26 (2.10)	6.47 (1.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
	Type of Statistical Test	Superiority
	Comments	The statistical analysis was applied to both groups.
Statistical Test of Hypothesis	p-Value	.604
	Comments
	Method	Mixed Models Analysis
	Comments	All models adjusted for age and duration of diabetes.

3. Secondary Outcome

Title	Hemoglobin A1c (A1C)
Description	A blood test that measures the percentage of glycated hemoglobin in red blood cells as a means of estimating the average blood sugar concentrations for the preceding two to three months. Lower percentage denote better blood glucose levels and may range from 4.5% in persons without diabetes t0 >15% in persons with poorly managed hyperglycemia. . An A1C <7% has been associated with prevention of diabetes complications. A1C>9% denotes chronic,severe blood glucose elevation. All tests were performed at VAPHS according to National Glyco-hemoglobin Standardization Program-approved methods.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Number analyzed differs in one or more rows from overall number analyzed due to attrition, missed research assessment, missed visit or failure to go to the lab to have bloodwork done following the research assessment. Three participant in the intervention group and 2 participants in the DSME-alone group did not have A1C done following the 24 week assessment related to closure of the outpatient lab due to COVID-19. Analyzed as intention to treat with imputation moving last value forward.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	8.57 (1.49)	8.68 (1.63)
12 weeks	7.87 (1.23)	7.94 (1.22)
24 weeks	7.84 (1.38)	8.09 (1.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.911
	Comments
	Method	Mixed Models Analysis
	Comments	All models adjusted for Age and Duration of Diabetes

4. Secondary Outcome

Title	Mindfulness Attention and Awareness Scale (MAAS)
Description	A 15-item psychometrically validated questionnaire on a 6-point Likert scale (1=Almost Always and 6= Never) The scale is scored by computing the mean of the 15 items. (Minimum score = 1; maximum score = 6). Higher scores reflect higher levels of dispositional (trait) mindfulness. Average score in the general US population is 4.22. Mindfulness is a mental state achieved by focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Number analyzed differs in one or more rows from overall number analyzed due to attrition and missed or abbreviated visit. One participant had to leave the 24 week visit after completing just 3 of the questionnaires and before completing the other questionnaires. He was then lost to follow-up. He was retained in the Intention-to-Treat analysis since 3 assessments including the primary outcome assessment were completed. Analyzed as intention to treat with imputation moving last value forward.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	4.37 (0.93)	4.25 (0.85)
12 weeks	4.49 (0.96)	4.42 (0.85)
24 weeks	4.52 (1.04)	4.47 (0.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.940
	Comments
	Method	Mixed Models Analysis
	Comments	All models were adjusted for age and duration of diabetes.

5. Secondary Outcome

Title	Body Weight
Description	Weight in pounds
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Number analyzed differs in one or more rows from overall number analyzed due to attrition or missed visit. Analyzed as intention to treat with imputation moving last value forward.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	227.80 (40.14)	233.64 (50.15)
12 weeks	229.16 (38.97)	231.24 (48.29)
24 weeks	229.63 (38.92)	231.04 (49.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.305
	Comments
	Method	Mixed Models Analysis
	Comments	All models adjusted for Age and Duration of Diabetes

6. Secondary Outcome

Title	Blood Pressure
Description	Change in mean arterial blood pressure, calculated as blood pressure + 2 (diastolic blood pressure) divided by 3.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Number analyzed differs in one or more rows from overall number analyzed due to attrition, missed visit or shortened visit. Two participants did not have their BP taken at week 24 due to social distancing and COVID-19 precautions. Analyzed as intention to treat with imputation moving last value forward.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	99.46 (12.04)	100.26 (13.59)
12 weeks	98.51 (13.02)	95.77 (13.82)
24 weeks	99.61 (13.90)	96.85 (13.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.228
	Comments
	Method	Mixed Models Analysis
	Comments	All models adjusted for age and duration of diabetes.

7. Secondary Outcome

Title	Patient Health Questionnaire (PHQ8)
Description	The Patient Health Questionnaire (PHQ-8) is a standardized, validated scale that assesses 8 key symptoms of depression experienced over the prior two weeks on a 4-point Likert scale (0=not at all; 3= nearly every day). It is the same as the PHQ-9, without the question regarding suicidal ideation. Score is the sum of the 8 items (Minimum value =0; Maximum= 24). A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Number analyzed differs in one or more rows from overall number analyzed due to attrition, missed visit or missed assessments.One participant had to leave the 24 week visit after completing just 3 of the questionnaires. He was then lost to follow-up. He was retained in the Intention-to-Treat analysis since 3 assessments including the primary outcome assessment (PAID) were completed. Analyzed as intention to treat with imputation moving last value forward.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	8.22 (5.66)	9.07 (5.78)
12 weeks	5.98 (5.05)	6.97 (4.96)
24 weeks	5.61 (5.46)	7.20 (4.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Differing sample sizes are due to attrition and missed research visits. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.671
	Comments
	Method	Mixed Models Analysis
	Comments	All models were adjusted for age and duration of diabetes.

8. Secondary Outcome

Title	PTSD Checklist- Civilian Version (PCL-C)
Description	The Abbreviated PCL-C is a validated 6-item civilian version of the PTSD check- list designed for use in general medical settings to assess symptoms of PTSD using a 5-point Likert scale. Scores reflect how much the participant has been bothered by specific PTSD symptoms during the past month. (0= "not at all; 4= "extremely") .Scores are summed. (Minimum value =0; maximum values = 24). Scores >14 are suggestive of PTSD, with higher scores reflecting greater PTSD symptoms.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Number analyzed differs in one or more rows from overall number analyzed due to attrition, missed or incomplete assessments. One participant left the 24- week visit early after completing just 3 of the questionnaires. He was then lost to follow-up. He was retained in the Intention-to-Treat analysis since 3 assessments including that for the primary outcome assessment were completed. Analyzed as intention to treat with imputation moving last value forward.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	13.22 (5.71)	13.90 (5.69)
12 weeks	11.63 (4.87)	12.49 (5.15)
24 weeks	11.09 (5.71)	12.62 (5.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.571
	Comments
	Method	Mixed Models Analysis
	Comments	All models were adjusted for age and duration of diabetes.

9. Secondary Outcome

Title	Summary of Diabetes Self-Care Activities (SDSCA), General Diet
Description	A 2-item subscale of the psychometrically validated SDSCA that measures the frequency of general dietary behaviors each day over the past 7-days and number of days per week over the past month (0= no days; 7 = 7 days). Scores = mean number of days per week ( Minimum score =0; maximum score = 7) . Higher scores denote healthier dietary behaviors.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Number analyzed differs in one or more rows from overall number analyzed due to attrition or missed visit.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	3.25 (2.07)	3.51 (1.90)
12 week	4.60 (1.83)	4.20 (1.51)
24 weeks	4.93 (1.51)	3.88 (1.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Mixed Models Analysis
	Comments	All models adjusted for age and duration of diabetes.

10. Secondary Outcome

Title	Summary of Diabetes Self-Care Activities (SDSCA), Specific Diet
Description	A 2-item subscale of the psychometrically validated SDSCA that measures the frequency of eating fruits and vegetables and high fat foods each day over the past 7-days. Minimum maximum values = (0= no days; 7 = 7 days). 1 item is scored as mean number of days (Minimum score =0; maximum score = 7), while the 2nd item is summed and reversed (0= 7days; 7= 0 days). The scores for the two items are summed for the subscale score (Minimum score=0; maximum score =7) Higher scores denote healthier dietary behaviors. Each subscale of the SDSCA is scored separately, without a calculated composite score.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Differing sample sizes are due to attrition and missed research visits.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	66
Baseline	3.28 (1.62)	2.97 (3.57)
12 weeks	3.71 (1.39)	3.57 (1.39)
24 weeks	4.01 (1.40)	3.55 (1.45)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.632
	Comments
	Method	Mixed Models Analysis
	Comments	All models adjusted for age and duration of diabetes.

11. Secondary Outcome

Title	Summary of Diabetes Self-Care Activities (SDSCA) Space Carbohydrates
Description	One item from the SDSCA that assesses the number of days over the past 7-days in which the participant spaced carbohydrates evenly throughout the day. Minimum score 0; maximum score 7. Higher scores denote healthier dietary behaviors.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Differing sample sizes are due to attrition and missed research visits.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	2.91 (2.45)	2.64 (2.04)
12 weeks	3.76 (1.95)	3.51 (2.17)
24 weeks	4.42 (1.99)	3.43 (2.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.219
	Comments
	Method	Mixed Models Analysis
	Comments	All models were adjusted for age and duration of diabetes.

12. Secondary Outcome

Title	Summary of Diabetes Self-Care Activities (SDSCA)- Exercise
Description	A 2-item subscale of the SDSCA that measures the number of days over the past 7-days on which the participant engaged in physical activity . Score = mean score of days over the past 7 days (Min.=1; Max.=7). Higher scores denote healthier exercise behaviors. Each SDSCA subscale scored separately.
Time Frame	baseline, 12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

Differing sample sizes are due to attrition and missed research visits.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	2.82 (2.09)	2.49 (2.06)
12 weeks	3.04 (2.24)	3.02 (2.33)
24 weeks	3.31 (2.10)	3.09 (2.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.931
	Comments
	Method	Mixed Models Analysis
	Comments	All models were adjusted for age and duration of diabetes.

13. Secondary Outcome

Title	Summary of Diabetes Self-Care Activities (SDSCA)- - Footcare
Description	A 2-item subscale of the SDSCA that measures the number of days the participant 1) inspected their feet and 2) inspected the inside of their shoes over the past 7-days. Score = mean number of days (Min=0; max=7). Higher scores denote healthier footcare behaviors.
Time Frame	baseline, 12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

Differing sample sizes are due to attrition and missed research visits.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	3.57 (2.30)	4.04 (2.42)
12 weeks	4.58 (2.18)	4.81 (2.13)
24 weeks	4.70 (2.25)	4.85 (2.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.627
	Comments
	Method	Mixed Models Analysis
	Comments	All models were adjusted for age and duration of diabetes.

14. Secondary Outcome

Title	Summary of Diabetes Self-Care Activities (SDSCA)- Blood Glucose Testing
Description	A 2-item subscale of the SDSCA that measures 1) the number of days on which the participant tested their blood glucose over the past 7 days and 2) the number of days on which they tested their blood glucose according to the number of times recommended by their health care provider over the past 7-days. Scores= mean number of days per week. Minimum score is 0 Maximum score is 7.Higher scores denote healthier self-monitoring behaviors. Each SDSCA subscale scored separately
Time Frame	baseline, 12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

Differing sample sizes are due to attrition and missed research visits or skipped questionnaires. One person in each group did not complete the questionnaire at baseline because they were not prescribed blood glucose monitoring by their diabetes care providers.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	64	66
Baseline	4.68 (2.71)	4.94 (2.54)
12 weeks	5.00 (2.50)	4.92 (2.19)
24 weeks	5.19 (2.33)	4.56 (2.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.60
	Comments
	Method	Mixed Models Analysis
	Comments	All models were adjusted for age and duration of diabetes.

15. Secondary Outcome

Title	Summary of Diabetes Self-Care Activities (SDSCA)- - Smoking
Description	A 2-item subscale of the SDSCA that measures 1) whether the participant smoked even a puff of a cigarette in the past 7 days (0=no; 1= yes) and 2) if so, the number of cigarettes smoked on an average day. The scores are summed. Minimum score =0, maximum score = >40. Lower scores denote healthier smoking behaviors.
Time Frame	baseline,12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

Differing sample sizes are due to attrition and missed research visits or incomplete assessment. Two participants in the DSME + Mind-STRIDE intervention group did not complete the Smoking subset of the SDSCA because they do not smoke.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	63	67
Baseline	2.82 (5.79)	2.69 (6.14)
12 weeks	2.13 (5.65)	3.03 (6.52)
24 weeks	2.12 (6.45)	2.83 (6.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.461
	Comments
	Method	Mixed Models Analysis
	Comments	All models were adjusted for age and duration of diabetes.

16. Secondary Outcome

Title	Summary of Diabetes Self-Care Activities (SDSCA)- - Medication Adherence
Description	A 2-item subscale of the SDCSA that measures the frequency of 1) taking prescribed insulin and 2)prescribed number of diabetes pills each day over the past 7-days. Scores from the 2 items are summed. Minimum score =0; maximum score = 7). Higher scores denote greater adherence to diabetes medications. Participants entered N/A if they were not prescribed insulin or diabetes pills. Each subscale of the SDSCA is scored independently with no calculated composite score.
Time Frame	baseline, 12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

Differing sample sizes are due to attrition, missed research visits or missing assessment questions. One person in Usual Care Control Group did not take any diabetes medications as reflected in the overall number of participants analyzed in that group.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	66
Baseline	6.49 (1.17)	6.30 (1.50)
12 weeks	6.28 (1.79)	6.02 (1.76)
24 weeks	6.45 (1.52)	6.28 (1.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.906
	Comments
	Method	Mixed Models Analysis
	Comments	All models were adjusted for age and duration of diabetes.

17. Other Pre-specified Outcome

Title	Change in 6-item PROMIS Short Form v1.0 Pain Interference 6 b
Description	A psychometrically validated 7-item instrument on a 5 point Likert scale (1= "not at all"- 5 and "very much") determining the degree to which pain has interfered with aspects of daily living during the past 7 days. It is a general and not disease-specific measure of pain. Scores are summed (Min. value = 6; Max value =35). Total raw scores are then converted into a T-score for each participant. The T-scores rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A score of 50 is the average for the United States general population with a standard deviation of 10.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Number analyzed differs in one or more rows from overall number analyzed due to attrition, missed visits, or skipped assessments. One participant had to leave the 24 week before completing the Pain Interference assessment. He was then lost to follow-up. He was retained in the Intention-to-Treat analysis because he completed 3 of the other assessments including the primary outcome assessment.. Analyzed as intention to treat with imputation moving last value forward.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	56.68 (9.30)	58.52 (8.64)
12 weeks	54.66 (9.22)	57.08 (8.78)
24 weeks	53.97 (10.29)	56.84 (8.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.856
	Comments
	Method	Mixed Models Analysis
	Comments	All models were adjusted for age and duration of diabetes.

18. Other Pre-specified Outcome

Title	Insomnia Severity Index (ISI)
Description	Seven psychometrically tested items on a 4 point Likert scale that measure difficulty falling asleep and staying asleep (0= none; 4=very severe) and satisfaction with current sleep patterns (0=very satisfied; 4=very dissatisfied), Noticeable impairment of quality of life (0= not noticeable; 4= very much noticeable), Worry/distress re: sleep (0=not at all worried; 4=very much worried); Interference of sleep problem to daily functioning (0=not interfering; 4= very much interfering). Scores are summed. Minimum score = 0; maximum score = 20). Higher scores denote greater insomnia severity. Scores over 14 denote insomnia; Scores 8 to 14 denote subthreshold insomnia.
Time Frame	baseline, 12 weeks and 24 weeks

Outcome Measure Data

Analysis Population Description

Number analyzed differs in one or more rows from overall number analyzed due to attrition,missed visits or skipped assessments. One participant had to leave the 24 week visit before completing the ISI. He was then lost to follow-up. He was retained in the Intention-to-Treat analysis since he completed 3 of the other assessments including the primary outcome assessment. Analyzed as intention to treat with imputation moving last value forward.

Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE	DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	Usual care control
Measure Participants	65	67
Baseline	11.00 (6.12)	11.81 (7.51)
12 weeks	9.20 (7.15)	10.34 (6.79)
24 weeks	8.48 (6.48)	10.14 (7.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetes Self Management Education (DSME) + Mind-STRIDE, DSME Alone
	Comments	The statistical analysis was applied to both groups.
	Type of Statistical Test	Superiority
	Comments	Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	Mixed Models Analysis
	Comments	All models adjusted for age and duration of diabetes.

Adverse Events

Time Frame	6 months
Arm/Group Title	Diabetes Self Management Education (DSME) + Mind-STRIDE		DSME Alone
Arm/Group Description	Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education		Usual care control
All Cause Mortality
	Diabetes Self Management Education (DSME) + Mind-STRIDE		DSME Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/67 (0%)
Serious Adverse Events
	Diabetes Self Management Education (DSME) + Mind-STRIDE		DSME Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/67 (0%)
Other (Not Including Serious) Adverse Events
	Diabetes Self Management Education (DSME) + Mind-STRIDE		DSME Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/67 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.