Mindfulness: a Novel Approach for the Management of Diabetes-related Distress
Primary Purpose
Emotional Distress, Type 2 Diabetes, Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Sponsored by
About this trial
This is an interventional treatment trial for Emotional Distress
Eligibility Criteria
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
Sites / Locations
- University of North Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness Based Stress Reduction
Health Education Control
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
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.
Mean 24 hour ambulatory systolic blood pressure
Mean systolic blood pressure over 24 hours.
Mean 24 hour diastolic ambulatory blood pressure
Mean diastolic blood pressure over 24 hours
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.
Depression
Using the Beck Depression Inventory we will assess symptoms of depression using this standardized patient reported outcome.
State Anxiety
Using the State and Trait Anxiety Assessment we will measure "state" anxiety.
Trait Anxiety
Using the State and Trait Anxiety Survey we will assess "trait" anxiety.
Social Support
Using the Duke Social Support and Stress Scale we will assess the degree of social support participants report in their lives.
Coping Style
Using the Coping Orientation to Problems Experienced Scale, we will evaluate the various coping styles and how they may change over time.
General Stress
Using the Perceived Stress Scale we will assess general life stressors.
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
Cortisol Awakening Response
We will measure the cortisol awakening response using measures of cortisol prior to arising and 30 minutes after waking up.
IL-6
IL-6 is an assessment of systemic inflammation and will be measured in serum.
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.
Average 24 hour glucose by continuous glucose monitor (cgm)
Average cgm glucose over 24 hours
Average night time glucose
Average night time glucose from 10pm-6am using continuous glucose monitoring values
Average day time glucose
Average day time glucose from 6am-10pm using continuous glucose monitoring values
Block Food Frequency Questionnaire
Standardized assessment of dietary patterns
Mean Day Systolic Ambulatory Blood Pressure
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm
Mean Day Diastolic Ambulatory Blood Pressure
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm
Mean Night Systolic Ambulatory Blood Pressure
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am.
Mean Night Diastolic Ambulatory Blood Pressure
The average diastolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am.
Full Information
NCT ID
NCT01805245
First Posted
June 15, 2012
Last Updated
April 17, 2017
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT01805245
Brief Title
Mindfulness: a Novel Approach for the Management of Diabetes-related Distress
Official Title
Mindfulness: a Novel Approach for the Management of Diabetes-related Distress
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Distress, Type 2 Diabetes, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Stress Reduction
Arm Type
Experimental
Arm Title
Health Education Control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
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
Primary Outcome Measure Information:
Title
HgA1c
Description
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
Title
Diabetes Distress
Description
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 Outcome Measure Information:
Title
SF36 Physical Health Score
Description
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
Title
SF36 Mental Health Score
Description
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
Title
Mean 24 hour ambulatory systolic blood pressure
Description
Mean systolic blood pressure over 24 hours.
Time Frame
0,8,24 weeks
Title
Mean 24 hour diastolic ambulatory blood pressure
Description
Mean diastolic blood pressure over 24 hours
Time Frame
0,8,24 weeks
Title
HOMA-IR
Description
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
Title
Depression
Description
Using the Beck Depression Inventory we will assess symptoms of depression using this standardized patient reported outcome.
Time Frame
0,8,24 weeks
Title
State Anxiety
Description
Using the State and Trait Anxiety Assessment we will measure "state" anxiety.
Time Frame
0,8,24 weeks
Title
Trait Anxiety
Description
Using the State and Trait Anxiety Survey we will assess "trait" anxiety.
Time Frame
0,8,24 weeks
Title
Social Support
Description
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
Title
Coping Style
Description
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
Title
General Stress
Description
Using the Perceived Stress Scale we will assess general life stressors.
Time Frame
0,8,24 weeks
Title
Cortisol 24 hour area under the curve
Description
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
Title
Cortisol Awakening Response
Description
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
Title
IL-6
Description
IL-6 is an assessment of systemic inflammation and will be measured in serum.
Time Frame
0,8, 24 weeks
Title
Summary of Diabetes Self-Care Activities
Description
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
Title
Average 24 hour glucose by continuous glucose monitor (cgm)
Description
Average cgm glucose over 24 hours
Time Frame
0,8,24 weeks
Title
Average night time glucose
Description
Average night time glucose from 10pm-6am using continuous glucose monitoring values
Time Frame
0,8,24 weeks
Title
Average day time glucose
Description
Average day time glucose from 6am-10pm using continuous glucose monitoring values
Time Frame
0,8,24 weeks
Title
Block Food Frequency Questionnaire
Description
Standardized assessment of dietary patterns
Time Frame
Week 0
Title
Mean Day Systolic Ambulatory Blood Pressure
Description
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm
Time Frame
0,8,24 weeks
Title
Mean Day Diastolic Ambulatory Blood Pressure
Description
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm
Time Frame
0,8,24 weeks
Title
Mean Night Systolic Ambulatory Blood Pressure
Description
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am.
Time Frame
0,8,24 weeks
Title
Mean Night Diastolic Ambulatory Blood Pressure
Description
The average diastolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am.
Time Frame
0,8,24 weeks
Other Pre-specified Outcome Measures:
Title
Mindfulness
Description
To assess mindfulness we will utilize the Five Facet Mindfulness Questionnaire.
Time Frame
0,8,24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Young, MD, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mindfulness: a Novel Approach for the Management of Diabetes-related Distress
We'll reach out to this number within 24 hrs