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African-Americans suffer from increased prevalence of both type 2 diabetes and diabetes complications, reflecting a combination of psychobehavioral factors as well as metabolic dysfunction. In this process, depression may contribute to both the genesis of type 2 diabetes (through impact on neurohormonal activation, inflammatory mediators, and insulin resistance), and difficulties in management (through decreased adherence to diet plans, medication, and scheduled appointments). Our preliminary data from the Grady Diabetes Clinic indicates that depression may be common in African-Americans with diabetes, that depression is a factor in non-adherence, and that non-adherence leads to poor glycemic control - a direct cause of diabetes complications. What is not known is: how treatment of depression could lead to both neurohormonal and psychobiological improvement, with improved patient adherence and glycemic control.
To determine the psychobehavioral and neurohormonal mechanisms of effective treatment, we will conduct a randomized, double-blind, placebo-controlled trial in patients with major depression, who will receive either: (i) computer-based cognitive behavioral therapy (CBT) program entitled "Beating the Blues" + placebo, or (ii) computer-based cognitive behavioral therapy (CBT) program entitled "Beating the Blues" + the SSRI antidepressant escitalopram. We will assess (a) glycemic control (levels of HbA1c), in relation to (b) adherence (keeping scheduled return appointments, diet, exercise, and glucose monitoring), (c) depressive symptoms (neurocognitive and neurobehavioral symptoms determined by self- and observer-rated scales), and (d) the four pathways of neurometabolic function.
Study visits will occur once a month for 6 months. Should patients report severe environmental stressors (such as marital conflict, loss of family member or job, being exposed to trauma), patients will be offered an intensification of their contact with study personnel, e.g. weekly contact by phone or "in-person" visits to see study personnel at the Grady Diabetes Clinic.
After completion of 6 months, patients may enter an open-label treatment with escitalopram or be tapered off their study medication. If patients develop worsening depressed mood, at any time during the study they will be offered treatment with open-label escitalopram or an alternative antidepressant for the remainder of the 52 weeks of the study.
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Cognitive Behavior Therapy, Lexapro
Grady Hospital Diabetes Clinic
Published on BioPortfolio: 2014-08-27T03:49:22-0400
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