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



Status:Active, not recruiting
Conditions:Psychiatric, Diabetes
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:30 - Any
Updated:4/21/2016
Start Date:January 2012
End Date:December 2015

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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.


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
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Chapel Hill, North Carolina 27599
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