Depression Therapy to Improve Cardiovascular Risk in HIV

NCT02309372 | Completed Results DMC

• 1 other identifier: R01HL126557
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; HIV

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12 of participation

Secondary Outcomes (3)

• 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

Study Arms (2)

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

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

Behavioral: Beating the Blues

Usual Care

NO INTERVENTION

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.

Interventions

Beating the Blues BEHAVIORAL

Computerized depression treatment intervention

Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Known or suspected malignancy requiring systemic treatment within 180 days of screening
• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Indiana University Health University Hospital, Indiana Clinical Research Center

Indianapolis, Indiana, 46202, United States

Location

Infectious Diseases Research Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Samir K. Gupta, MD, MS
• Organization: Indiana University School of Medicine

sgupta1@iu.edu

3172747926

Study Officials

• Samir K Gupta, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jesse C Stewart, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: April 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: July 14, 2020
• Results First Posted: July 14, 2020

Record last verified: 2020-07

Locations

US (2)