Mindfulness: a Novel Approach for the Management of Diabetes-related Distress

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of stress reduction on physiological and psychological variables in adults with Type 2 diabetes (T2DM) who have moderate to severe levels of diabetes-related emotional distress. Subjects will be randomized to one of two interventions. We will evaluate the impact of the interventions on glucose metabolism, blood pressure, diabetes-related distress and quality of life. Additionally, we will investigate the role of neuroendocrine dysfunction, systemic inflammation and diabetes self-care practices as mediators in the relationship between increased stress, adverse glucose metabolism and elevated blood pressure in those subjects with T2DM.

Official Title
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Mindfulness: a Novel Approach for the Management of Diabetes-related Distress

Conditions
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Stress, Emotional Distress, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 30 years Male or female Duration of diabetes 1-15 years from time of initial diagnosis Diagnosis of T2DM made/confirmed by physician Completed diabetes education in the past Most recent HgA1c >7%; measurement must be within the past 6 months either in physicians office or at the Thriving with Diabetes Boot Camp Class Treatment for diabetes must include any or all of the following modalities: diet, exercise, oral medications, insulin or other injectable diabetic medication Score > 30 on the Problem Area in Diabetes (PAID) Questionnaire Able to use a glucometer for self-monitoring of blood glucose values Most recent clinic blood pressure less than 180/95 Exclusion Criteria: History of ketoacidosis Age at diagnosis of T2DM < 30 years Score >15 on the PHQ-9 Previous training in relaxation or meditation techniques Current practice of yoga, tai chi or any other mind-body movement for > 60 minutes per week Current use of a psychoactive drug for less than 3 months or not yet on a stable dose Inability to participate fully or behave appropriately in the group treatment setting, as observed by baseline acknowledgement of substance abuse, psychotic episode(s), psychiatric hospitalization or history of self- harm within the past 2 years, or current suicidal or homicidal ideation Inability to complete standardized instruments because of a cognitive deficit or language barrier Current use or use within the past 3 months of oral glucocorticoids, excluding intraocular, topical or inhaled preparations History of inflammatory diseases including rheumatoid arthritis and inflammatory bowel disease Use of immune modulating agents Night shift work or other type of schedule in which sleep wake cycle is disrupted Women who consume > 7 alcoholic drinks per week and men who consume > 14 drinks per week Current use or history of daily tobacco use within the past 1 year End stage renal failure on dialysis Pregnancy or post partum <3 months Subjects with known secondary causes of hypertension including renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronemia Non-dominant arm circumference > 46cm Unwilling to accept randomization

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Stress Reduction<br> | Behavioral: Mindfulness Based Stress Reduction<br>* Standard 8-week MBSR program; classes meet for 2.5 hours once weekly The health education control group meets at the same time and for the same amount of time<br>|
| Active Comparator: Health Education Control<br> | Behavioral: Mindfulness Based Stress Reduction<br>* Standard 8-week MBSR program; classes meet for 2.5 hours once weekly The health education control group meets at the same time and for the same amount of time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HgA1c | We will assess change in glycemic control using the A1c. It will be measured at baseline, immediately following the 8 week intervention and at 24 weeks from baseline. | 0,8,24 weeks | 
| Diabetes Distress | The Problem Areas in Diabetes will be used to assess the change in diabetes emotional distress at baseline, immediately following the 8 week intervention and at 24 weeks from baseline | 0,8,24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF36 Physical Health Score | This measure is a patient reported outcome assessing general quality of life and will be assessed using the standardized SF36 tool. | 0, 8,24 weeks | 
| SF36 Mental Health Score | This measure is a patient reported outcome assessing general quality of life and will be assessed using the standardized SF36 tool. | 0,8,24 weeks | 
| Mean 24 hour ambulatory systolic blood pressure | Mean systolic blood pressure over 24 hours. | 0,8,24 weeks | 
| Mean 24 hour diastolic ambulatory blood pressure | Mean diastolic blood pressure over 24 hours | 0,8,24 weeks | 
| HOMA-IR | For those participants that are not using insulin, we will assess the degree of insulin resistance using the HOMA-IR, which is derived from the fasting insulin and fasting glucose. | 0,8,24 weeks | 
| Depression | Using the Beck Depression Inventory we will assess symptoms of depression using this standardized patient reported outcome. | 0,8,24 weeks | 
| State Anxiety | Using the State and Trait Anxiety Assessment we will measure state anxiety. | 0,8,24 weeks | 
| Trait Anxiety | Using the State and Trait Anxiety Survey we will assess trait anxiety. | 0,8,24 weeks | 
| Social Support | Using the Duke Social Support and Stress Scale we will assess the degree of social support participants report in their lives. | 0,8,24 weeks | 
| Coping Style | Using the Coping Orientation to Problems Experienced Scale, we will evaluate the various coping styles and how they may change over time. | 0,8,24 weeks | 
| General Stress | Using the Perceived Stress Scale we will assess general life stressors. | 0,8,24 weeks | 
| Cortisol 24 hour area under the curve | Calculating the area under the curve for 24 hours we will assess cortisol secretion as a physiological assessment of stress | 0,8,24 weeks | 
| Cortisol Awakening Response | We will measure the cortisol awakening response using measures of cortisol prior to arising and 30 minutes after waking up. | 0,8,24 weeks | 
| IL-6 | IL-6 is an assessment of systemic inflammation and will be measured in serum. | 0,8, 24 weeks | 
| Summary of Diabetes Self-Care Activities | This patient reported measure assesses the frequency which participants engage in self-care activities that are critical for DM self-management. | 0,8,24 weeks | 
| Average 24 hour glucose by continuous glucose monitor (cgm) | Average cgm glucose over 24 hours | 0,8,24 weeks | 
| Average night time glucose | Average night time glucose from 10pm-6am using continuous glucose monitoring values | 0,8,24 weeks | 
| Average day time glucose | Average day time glucose from 6am-10pm using continuous glucose monitoring values | 0,8,24 weeks | 
| Block Food Frequency Questionnaire | Standardized assessment of dietary patterns | Week 0 | 
| Mean Day Systolic Ambulatory Blood Pressure | The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm | 0,8,24 weeks | 
| Mean Day Diastolic Ambulatory Blood Pressure | The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm | 0,8,24 weeks | 
| Mean Night Systolic Ambulatory Blood Pressure | The average systolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am. | 0,8,24 weeks | 
| Mean Night Diastolic Ambulatory Blood Pressure | The average diastolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am. | 0,8,24 weeks |