NCT02309372CompletedNot Applicable
A Randomized, Controlled Pilot Trial Assessing the Utility of Cognitive Behavioral Therapy to Improve Endothelial Function and Reduce Inflammation in Depressed, Virologically-Suppressed, Antiretroviral-Treated, HIV-infected Adults
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 54
- Locations
- 4
- Primary Endpoint
- Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Brachial Artery Flow-mediated Dilation From Baseline to Week 12
Time Frame: 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 Outcomes
- Changes in Circulating IL-6 From Baseline to Week 12(Baseline and 12 weeks)
- Change in hsCRP From Baseline to Week 12(12 weeks)
- Change in D-dimer From Baseline to Week 12(12 weeks)
Investigators
Samir K Gupta, MD, MS
Professor of Medicine
Indiana University
Study Sites (4)
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