Status:
COMPLETED
Mindfulness: a Novel Approach for the Management of Diabetes-related Distress
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Emotional Distress
Type 2 Diabetes
Eligibility:
All Genders
30+ years
Phase:
NA
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 diabete...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01805245
Start Date
January 1 2012
End Date
December 1 2015
Last Update
April 19 2017
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599