Depression-Diabetes Mechanisms: Urban African Americans
Condition: Diabetes; Depression
MeSH terms: Diabetes Mellitus; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      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). The 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.
    

Detailed description: 
      To determine the psychobehavioral and neurohormonal mechanisms of effective treatment, the
      investigator 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. The investigator will assess (a) glycemic control (levels of
      glycated hemoglobin (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.
    

Intervention name(s): Beating the Blues; Escitalopram; Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Beating the Blues is a computerized cognitive behavioral therapy.; Escitalopram is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It's a 10 mg pill taken once or twice daily for 6 months.; A sugar pill taken as one to two tablets daily for 6 months.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment