BACKGROUND/RATIONALE:
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 our pilot work, we 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 we 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.

OBJECTIVE(S):
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, we conducted a randomized controlled trial of 132 Veterans at a large VA medical center in southwest PA. Participants were assigned to one of two study conditions: an experimental group that receives routine diabetes education plus Mind-STRIDE(m=65), or to a usual care group that receives diabetes education alone (n=67). DRD, diabetes self-efficacy, diabetes self-care behaviors, PTSD, depression were assessed by self-report questionnaires. Metabolic control (Hemoglobin A1c) was assessed using standard laboratory procedures. Body weight and blood pressure were obtained by the research staff. Data was collected at baseline, 12-weeks, and 24-weeks, and was intent to treat analyses were completed using mixed-effects models. Telephone interviews were conducted at 15-weeks post-intervention with a purposively sampled subset of 25 participants from the experimental group. It was analyzed using modified Grounded Theory methods. Quantitative and qualitative are being compared and interpreted using Convergent Parallel Design.

FINDINGS/RESULTS:
There were 476 veterans eligible for pre-screening. Of those 192 were prescreened, 164 met eligibility criteria, and 132 were randomly assigned to receive either Mind-STRIDE (n=65) or control DSMES (n=67). Retention rates were 83% (n=54) and 90% (n=60) in the intervention and control groups respectively. See Figure 1 for CONSORT chart.
Participant Characteristics Table 1: Participants tended to be older (60.7 ± 10.6 years); white (67.4%) males (91.7 %) who were obese or overweight (mean BMI 34.3 kg/M2). Baseline mean HbA1C was 8.6 ± 1.6% (70 ± 1.12) and duration of diabetes was 13.0 ±10.4 years. More than two thirds of participants (n= 93; 70.5%) were using insulin; the remainder were using oral or injectable non-insulin diabetes medications. Mean Charlson comorbidity Index CCI score was 2.94, indicating mild to moderate risk of one-year mortality. The was no difference in the number of diabetes medication changes between randomized groups (p=.90).
Primary Outcome: Diabetes Distress (PAID) There were statistically significant reductions in DD over time in both the intervention (p<.0001) and control arms (p<.001) Table 2. Group by time interaction for DD was not statistically significant (p=0.153) over 24 weeks.
However, group by time analyses between distal weeks 12 and 24 showed a statistically significant decrease in DD (p=.02) for the intervention group but not the control (p=0.96) Figure 2. Analyses for DD stratified by baseline HbA1C categories showed a statistically significant group by time effect in DD with baseline HbA1C <8.5% (p=.01), but not with HbA1C 8.5 (p=.80).
Secondary Outcomes Among diabetes self-care activities, there was a statistically significant group by time effect for general diet (p=.003) in the intervention group compared to control; there were no significant effects in the other self-care domains Table 2. Diabetes self-efficacy, PTSD, and depression improved significantly in both groups without statistically significant intervention effects Table 2. However, scatter plots showed non-significant trends toward improvement between distal timepoints of 12 and 24 weeks Figure 2. Mindfulness did not change in either arm.
There were statistically significant reductions in HbA1C over time in both groups without significant intervention effect. Examination of small, non-significant trends using scatter plots show sustained HbA1C less than 8% in the intervention arm between distal timepoints, while HbA1C trended above 8% in the control group Figure 2. Arterial BP (MAP) and body weight did not change in either group.
Satisfaction Of the 53 participants from the intervention arm who completed the satisfaction questionnaire after study completion, 96% (n=51) reported that Mind-STRIDE helped them manage diabetes more effectively, while 91% (n= 48) stated that Mind-STRIDE was the type of program they would have attended even if it were not part of a research study. Additionally, 87% (n=41) said it met their stress management needs, and 94% (n=50) would recommend it to a fellow veteran or friend with diabetes. Of the 41 participants who responded to additional questions added to the survey, 98% (n=40) indicated that they were satisfied or highly satisfied that a mindfulness intervention was incorporated into their diabetes care, and 29% (n=12) reported that they had sought out additional mindfulness resources. In addition, 37% (25/67) of the control group opted to receive the mindfulness training after completing the study, indicating interest in this type of program.
Home Practice Engagement Mind-STRIDE participants practiced mindfulness an average of three days per week and 20 minutes per occasion. Over half (33/65) were more engaged (n= 51%), 32% (n=21/65) were less engaged, and 17% (n= 11/65) were not engaged or dropped out. Of those who were more engaged, 70% (23/33) used the app and 18% (6/33) used the CD, while 34% (7/21) of those who were less engaged used the app and none used the CD. More engaged participants practiced a combination of formal and informal mindfulness. Less engaged participants generally practiced informally. Within-group analyses showed a statistically significant reduction in DD in both more engaged and less engaged categories over time, with greater effects in the more engaged category [95% CI B= -15.33 (-19.74, -10.92) p= <0.0001 vs. the less engaged category B= -9.38 (-13.76, -5.00) p=0001].


IMPACT:
This RCT addressed existing gaps in knowledge regarding the efficacy of mindfulness interventions for veterans with diabetes related distress, the effects of mindfulness as an adjunct to diabetes care and education for reducing diabetes distress.

It further showed that a technology supported MBSR-inspired mindfulness intervention integrated with conventional Diabetes Self-Management Education and Support (DSMES) significantly reduced diabetes related distress after 12 weeks compared to DSMES control, thus prolonging benefits of DSME. This finding might influence standards of care for diabetes to include mindfulness as a core component for appropriate veterans.

Our findings also showed significantly stronger improvement in general dietary behaviors compared to conventional DSMES, and support the notion that Mindful Awareness is core component of eating behavior change.

In addition, this study could inform candidate selection for future mindfulness studies and DSMES programs that include mindfulness, since effects on diabetes related distress were greater when HbA1C was only moderately elevated (<8.5%).

Lastly, non-significant trends toward improvement for diabetes self-efficacy and reduction of PTSD and depression symptoms in veterans with diabetes could inform further research in these areas.

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External Links for this Project

NIH Reporter

Grant Number: IK3HX001836-01A1
Link: https://reporter.nih.gov/project-details/9078367

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PUBLICATIONS:

Journal Articles

1. DiNardo MM, Greco C, Phares AD, Beyer NM, Youk AO, Obrosky DS, Morone NE, Owen JE, Saba SK, Suss SJ, Siminerio L. Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial. BMJ open diabetes research & care. 2022 Mar 1; 10(2). [view]
2. DiNardo MM, Phares AD, Jones HE, Beyer NM, Suss SJ, McInnes S, Rodriguez KL. Veterans' Experiences With Diabetes: A Qualitative Analysis. The Diabetes educator. 2020 Dec 1; 46(6):607-616. [view]

Journal Other

1. DiNardo MM, Youk A, Phares A. Trait Mindfulness Predicts Diabetes Distress in U.S. Veterans. [Abstract]. Global advances in health and medicine. 2020 Jun 10; ICIMH 2020 Abstracts(P07.13):doi:10.1177/2164956120912849. [view]

DRA: Aging, Older Veterans' Health and Care, Diabetes and Other Endocrine Disorders
DRE: Treatment - Observational, TRL - Applied/Translational
Keywords: Complementary and Alternative Practices, Diabetes, Health Promotion and Education, Patient Preferences, Symptom Management
MeSH Terms: none