Depression Therapy to Improve Cardiovascular Risk in HIV

NCT ID: NCT02309372

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-04-30

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).

Conditions

Depression; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavioral Therapy (CBT)

Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.

Group Type: EXPERIMENTAL

Beating the Blues

Intervention Type: BEHAVIORAL

Computerized depression treatment intervention

Usual Care

No specific depression care will be provided through this study for those assigned to this arm. However, the participant's caregiver may choose to provide depression treatment outside of this trial.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Beating the Blues

Computerized depression treatment intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Samir K Gupta, MD, MS

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samir K Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Jesse C Stewart, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Health University Hospital, Indiana Clinical Research Center

Indianapolis, Indiana, United States

Infectious Diseases Research Center

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HL126557

Identifier Type: NIH

Identifier Source: org_study_id

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