N/A
Completed N=132
Mindful Stress Reduction in Diabetes Self-management Education for Veterans
Source: ClinicalTrials.gov NCT02928952 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress) — 27.58; 31.24; 17.00; 20.83 units on a scale — p=0.153
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress) |
27.58; 31.24; 17.00; 20.83; 12.89; 21.15 | 0.153 |
| SECONDARY Diabetes Self-efficacy Scale (DSES) |
6.20; 5.77; 6.97; 6.40; 7.26; 6.47 | .604 |
| SECONDARY Hemoglobin A1c (A1C) |
8.57; 8.68; 7.87; 7.94; 7.84; 8.09 | 0.911 |
| SECONDARY Mindfulness Attention and Awareness Scale (MAAS) |
4.37; 4.25; 4.49; 4.42; 4.52; 4.47 | 0.940 |
| SECONDARY Body Weight |
227.80; 233.64; 229.16; 231.24; 229.63; 231.04 | 0.305 |
| SECONDARY Blood Pressure |
99.46; 100.26; 98.51; 95.77; 99.61; 96.85 | 0.228 |
| SECONDARY Patient Health Questionnaire (PHQ8) |
8.22; 9.07; 5.98; 6.97; 5.61; 7.20 | 0.671 |
| SECONDARY PTSD Checklist- Civilian Version (PCL-C) |
13.22; 13.90; 11.63; 12.49; 11.09; 12.62 | 0.571 |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA), General Diet |
3.25; 3.51; 4.60; 4.20; 4.93; 3.88 | 0.003 sig |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA), Specific Diet |
3.28; 2.97; 3.71; 3.57; 4.01; 3.55 | 0.632 |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA) Space Carbohydrates |
2.91; 2.64; 3.76; 3.51; 4.42; 3.43 | 0.219 |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA)- Exercise |
2.82; 2.49; 3.04; 3.02; 3.31; 3.09 | 0.931 |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA)- - Footcare |
3.57; 4.04; 4.58; 4.81; 4.70; 4.85 | 0.627 |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA)- Blood Glucose Testing |
4.68; 4.94; 5.00; 4.92; 5.19; 4.56 | 0.60 |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA)- - Smoking |
2.82; 2.69; 2.13; 3.03; 2.12; 2.83 | 0.461 |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA)- - Medication Adherence |
6.49; 6.30; 6.28; 6.02; 6.45; 6.28 | 0.906 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02928952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.