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

Completed · Not applicable

Conditions studied: Emotional Distress, Type 2 Diabetes, Stress

In brief

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.

Key facts

Study ID

NCT01805245

Run by

University of North Carolina, Chapel Hill

People needed

78

Starts

2012-01-01

Expected to finish

2015-12-01

Last updated by the study team

2017-04-19

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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