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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Experimental |
| |
| Health Education Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction | Behavioral | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mindfulness | To assess mindfulness we will utilize the Five Facet Mindfulness Questionnaire. | 0,8,24 weeks |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Laura A Young, MD, PhD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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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 |
| D004700 | Endocrine System Diseases |
| D004191 |
| Behavioral Disciplines and Activities |