This trial will determine if depression treatment will reduce cardiovascular risk in HIV-infected patients already receiving HIV treatments. Half of the participants will undergo a specific computerized depression treatment with the other half receiving usual care from their HIV providers.
The objectives of this study will be met by performing a 24-week, randomized, controlled, single-blinded, two-arm, parallel group, pilot trial at a single center. A total of 200 subjects may be screened to identify 110 participants to be enrolled and randomized. These participants will be ≥ 18 years old, have been receiving antiretroviral therapy for at least one year with an HIV viral load \< 75 copies/mL at screening, and have major depression using the PHQ-9 questionnaire. These participants will be randomized 1:1 to either depression treatment with the Beating-the-Blues cognitive behavioral therapy program (N=55) or usual care (N=55).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
Computerized depression treatment intervention
Indiana University Health University Hospital, Indiana Clinical Research Center
Indianapolis, Indiana, United States
Infectious Diseases Research Center
Indianapolis, Indiana, United States
Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12
Changes in flow-mediated dilation of the brachial artery from baseline to week 12. This is calculated by the FMD value at Week 12 minus the FMD value at baseline.
Time frame: Baseline and Week 12 of participation
Changes in Circulating IL-6 From Baseline to Week 12
Interleukin-6 (IL-6) is a measure of systemic inflammation. This is calculated by the IL-6 value at Week 12 minus the IL-6 value at baseline.
Time frame: Baseline and 12 weeks
Change in hsCRP From Baseline to Week 12
hsCRP (high sensitivity C-reactive protein) is a measure of systemic inflammation. This is calculated by the hsCRP value at Week 12 minus the hsCRP value at baseline.
Time frame: 12 weeks
Change in D-dimer From Baseline to Week 12
D-dimer is a measure of systemic coagulation. This is calculated by the D-dimer value at Week 12 minus the D-dimer value at baseline.
Time frame: 12 weeks
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