Depression- Diabetes Mechanisms: Urban African Americans
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.
Behavioral: Cognitive Behavior Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Depression- Diabetes Mechanisms: Urban African Americans|
- Glycemic control: Assessed as levels of HbA1c:
- Neurometabolic Variables: The impact of treatment on changes in HPA axis activation, sympathomedullary and other counter-regulatory hormones, immunoinflammatory factors, and insulin resistance.
- Adherence: The maintenance of scheduled appointments will be measured both by patients who keep their one-year appointments or not, and among those who return at one year, the percentage of interim appointments kept.
- Variability in followup: Since it is likely that some patients will not return for all scheduled follow-up appointments, we will compare characteristics of patients who dropped out vs. those who did not in the escitalopram and placebo groups.
- We will also compare changes in HbA1c and adherence in the two treatment arms (n=250 each) with the two groups from Aim #1 - depressed patients given "usual care" (n=500) and nondepressed patients (n=3000).
|Study Start Date:||May 2004|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209170
|United States, Georgia|
|Grady Hospital Diabetes Clinic|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Dominique L Musselman, MD, MS||Emory University|