Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209170
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2005-09-14
Brief Title:
Depression-Diabetes Mechanisms Urban African Americans
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Depression-Diabetes Mechanisms Urban African Americans
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg weekly contact by phone or in-person visits to see study personnel at the Grady Diabetes Clinic
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 eg weekly contact by phone or in-person visits to see study personnel at the Grady Diabetes Clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH069254-03 | NIH | None | httpsreporternihgovquickSearchR01MH069254-03 |