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Clinical Trials

MainTitle

Depression Therapy to Improve Cardiovascular Risk in HIV

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2017 by Samir K Gupta, MD, MS, Indiana University

Sponsor
Indiana University


Information provided by (Responsible Party)
Samir K Gupta, MD, MS, Indiana University

ClinicalTrials.gov Identifier
NCT02309372

First received: December 3, 2014
Last updated: September 27, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
Depression
HIV

Behavioral : Beating the Blues

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Samir K Gupta, MD, MS, Indiana University:

Primary Outcome Measures

  • Endothelial Function [ Time Frame: 12 weeks ]
    Changes in flow-mediated dilation of the brachial artery
Secondary Outcome Measures:
  • IL-6 [ Time Frame: 12 weeks ]
    Measure of systemic inflammation
  • hsCRP [ Time Frame: 12 weeks ]
    Measure of systemic inflammation
  • D-dimer [ Time Frame: 12 weeks ]
    Measure of systemic coagulation

Estimated Enrollment: 110
Study Start Date: April 2015
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy (CBT)
Those assigned to the CBT arm will undergo therapy with the Beating the Blues (BtB) computerized intervention.
Behavioral: Beating the Blues

Computerized depression treatment intervention

No 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.

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).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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 using PHQ-9 question #9 and positive responses to any of the 3 questions using the Patient Suicidality Form
  • 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 migraine headaches
  • 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 creatinine clearance < 60 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02309372

Contacts

Contact:   Danielle Grounds 317-278-0255
Contact:   Patricia Anderson 317-274-8473

Locations

United States, Indiana
Indiana University Health University Hospital, Indiana Clinical Research Center Recruiting
Indianapolis, Indiana, United States, 46202
Infectious Diseases Research Center Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Samir K Gupta, MD, MS

Sponsors and Collaborators

Indiana University

Investigators

Principal Investigator: Samir K Gupta, MD Indiana University School of Medicine
Principal Investigator: Jesse C Stewart, PhD Indiana University School of Medicine
More Information

More Information


Responsible Party: Samir K Gupta, MD, MS, Professor of Medicine, Indiana University  
ClinicalTrials.gov Identifier: NCT02309372   History of Changes  
Other Study ID Numbers: R01HL126557  
Study First Received: December 3, 2014  
Last Updated: September 27, 2017  

Additional relevant MeSH terms:
Depression
Depressive Disorder

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.