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

University of North Carolina, Chapel Hill78 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Emotional Distress Type 2 Diabetes Stress

Interventions

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \> 30 years 2. Male or female 3. Duration of diabetes 1-15 years from time of initial diagnosis 4. Diagnosis of T2DM made/confirmed by physician 5. Completed diabetes education in the past 6. 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 7. Treatment for diabetes must include any or all of the following modalities: diet, exercise, oral medications, insulin or other injectable diabetic medication 8. Score \> 30 on the Problem Area in Diabetes (PAID) Questionnaire 9. Able to use a glucometer for self-monitoring of blood glucose values 10. Most recent clinic blood pressure less than 180/95 Exclusion Criteria: 1. History of ketoacidosis 2. Age at diagnosis of T2DM \< 30 years 3. Score \>15 on the PHQ-9 4. Previous training in relaxation or meditation techniques 5. Current practice of yoga, tai chi or any other mind-body movement for \> 60 minutes per week 6. Current use of a psychoactive drug for less than 3 months or not yet on a stable dose 7. 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 8. Inability to complete standardized instruments because of a cognitive deficit or language barrier 9. Current use or use within the past 3 months of oral glucocorticoids, excluding intraocular, topical or inhaled preparations 10. History of inflammatory diseases including rheumatoid arthritis and inflammatory bowel disease 11. Use of immune modulating agents 12. Night shift work or other type of schedule in which sleep wake cycle is disrupted 13. Women who consume \> 7 alcoholic drinks per week and men who consume \> 14 drinks per week 14. Current use or history of daily tobacco use within the past 1 year 15. End stage renal failure on dialysis 16. Pregnancy or post partum \<3 months 17. Subjects with known secondary causes of hypertension including renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronemia 18. Non-dominant arm circumference \> 46cm 19. Unwilling to accept randomization

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 0,8,24 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 0,8,24 weeks

Mean 24 hour ambulatory systolic blood pressure

Mean systolic blood pressure over 24 hours.

Time frame: 0,8,24 weeks

Mean 24 hour diastolic ambulatory blood pressure

Mean diastolic blood pressure over 24 hours

Time frame: 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.

Time frame: 0,8,24 weeks

Depression

Using the Beck Depression Inventory we will assess symptoms of depression using this standardized patient reported outcome.

Time frame: 0,8,24 weeks

State Anxiety

Using the State and Trait Anxiety Assessment we will measure "state" anxiety.

Time frame: 0,8,24 weeks

Trait Anxiety

Using the State and Trait Anxiety Survey we will assess "trait" anxiety.

Time frame: 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.

Time frame: 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.

Time frame: 0,8,24 weeks

General Stress

Using the Perceived Stress Scale we will assess general life stressors.

Time frame: 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

Time frame: 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.

Time frame: 0,8,24 weeks

IL-6

IL-6 is an assessment of systemic inflammation and will be measured in serum.

Time frame: 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.

Time frame: 0,8,24 weeks

Average 24 hour glucose by continuous glucose monitor (cgm)

Average cgm glucose over 24 hours

Time frame: 0,8,24 weeks

Average night time glucose

Average night time glucose from 10pm-6am using continuous glucose monitoring values

Time frame: 0,8,24 weeks

Average day time glucose

Average day time glucose from 6am-10pm using continuous glucose monitoring values

Time frame: 0,8,24 weeks

Block Food Frequency Questionnaire

Standardized assessment of dietary patterns

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 0,8,24 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes