Mindful Stress Reduction in Diabetes Self-management Education for Veterans

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Mind-STRIDE

• Registration Number: NCT02928952
• Lead Sponsor: VA Office of Research and Development

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).

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 Timeline

• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-10
• Study Start: 2016-11-01
• Primary Completion: 2020-04-09
• Study Completion: 2020-04-09
• Results First Submitted: 2021-03-10
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-27
• Last Update Submitted: 2021-05-27
• Results First Posted: 2021-05-28
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Self Management Education (DSME) + Mind-STRIDE	Mind-STRIDE	Will receive routine diabetes self-management education + the Mind-STRIDE intervention

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Body Weight	baseline, 12 weeks and 24 weeks	Weight in pounds
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.

Trial Locations

Locations (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; 🇺🇸 Pittsburgh, Pennsylvania, United States