Depression Therapy to Improve Cardiovascular Risk in HIV
- Conditions
- DepressionHIV
- Interventions
- Behavioral: Beating the Blues
- Registration Number
- NCT02309372
- Lead Sponsor
- Indiana University
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- HIV-1 infection, documented by both: (1) any licensed rapid HIV test or HIV enzyme test kit at any time prior to study entry and (2) by at least one detectable HIV-1 antigen or at least one detectable plasma HIV-1 RNA viral load
- Age equal to or greater than 18 years
- Receipt of antiretroviral therapy of any kind for at least 360 days prior to screening
Note: Interruptions in ART of up to 14 days total during the 360 days prior to screening are allowed
- HIV-1 RNA level < 75 copies/mL at screening
NOTE: There are no CD4 cell count eligibility criteria for this trial
- For women who are still of reproductive potential, a negative urine pregnancy test
- Depression as defined by having a score ≥ 10 on the PHQ-9 questionnaire
- Inability to complete written, informed consent
- Incarceration at the time of any study visit
- Active suicidality, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions on the Patient Suicidality Form (with last suicide attempt within the past ten years)
- Diagnosed vascular disease (documented history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease)
- History of congestive heart failure, even if currently compensated
- Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosis, inflammatory bowel diseases, other collagen vascular diseases)
Note: Hepatitis B or C co-infections are NOT exclusionary
- Known or suspected malignancy requiring systemic treatment within 180 days of screening
NOTE: Localized treatment for skin cancers is not exclusionary
- History of Raynaud's phenomenon
- History of cardiac arrhythmias or cardiomyopathy
- Uncontrolled hyperthyroidism or hypothyroidism, defined as TSH values outside of the local reference range on most recent clinical assessment
- History of carotid bruits
- Systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg at screening
- Screening estimated glomerular filtration rate (eGFR) < 50 mL/min/1.732 (using the 2009 CKD-EPI equation) using a serum creatinine level measured at screening
- Screening glucose ≥ 140 mg/dL or hemoglobin A1c > 8.0%
- Screening total cholesterol > 240 mg/dL
- Therapy for serious medical illnesses within 14 days prior to screening
Note: Therapy for serious medical illnesses that overlaps with a main study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation
- Pregnancy or breastfeeding during the course of the study
- Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (of any dose), or anabolic steroids at screening
Note: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors
- Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- History of schizophrenia or bipolar disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behavioral Therapy (CBT) Beating the Blues Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
- Primary Outcome Measures
Name Time Method Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12 Baseline and Week 12 of participation 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.
- Secondary Outcome Measures
Name Time Method Changes in Circulating IL-6 From Baseline to Week 12 Baseline and 12 weeks 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.
Change in hsCRP From Baseline to Week 12 12 weeks 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.
Change in D-dimer From Baseline to Week 12 12 weeks 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.
Trial Locations
- Locations (2)
Infectious Diseases Research Center
🇺🇸Indianapolis, Indiana, United States
Indiana University Health University Hospital, Indiana Clinical Research Center
🇺🇸Indianapolis, Indiana, United States