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

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 Overview

• Status: Completed
• Conditions: Stress; Type 2 Diabetes; Emotional Distress
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Based Stress Reduction	Behavioral: Mindfulness Based Stress Reduction; 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
Active Comparator: Health Education Control	Behavioral: Mindfulness Based Stress Reduction; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness	To assess mindfulness we will utilize the Five Facet Mindfulness Questionnaire.	0,8,24 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Laura A Young, MD, PhD, University of North Carolina

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 15, 2012
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (Estimate): March 6, 2013

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 11-0333