Mindful Stress Reduction in Diabetes Self-management Education for Veterans
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/20/2018 |
| Start Date: | November 1, 2016 |
| End Date: | December 31, 2019 |
| Contact: | Monica M DiNardo, PhD ARNP CDE |
| Email: | Monica.Dinardo@va.gov |
| Phone: | (412) 360-2262 |
Effects of a Mindfulness Intervention Delivered Within Diabetes Education on Diabetes-related Outcomes in Military Veterans
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).
reduces feelings of stress and makes it easier to adhere to healthy behaviors that improve
diabetes outcomes (such as hemoglobin A1c).
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: Recruitment is ongoing as of fall 2016.
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: Recruitment is ongoing as of fall 2016.
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
We found this trial at
1
site
Pittsburgh, Pennsylvania 15240
Phone: (412) 360-2262
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