The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV

Prior treatment

• Active suicidality at Entry, 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 (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix).
• Therapy for serious medical illnesses within 14 days prior to the Entry Visit
  • NOTE: Therapy for serious medical illnesses that overlaps with a 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.
• Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit
  • 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
  • NOTE: Use of NSAIDS and aspirin are allowed
• Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.

Other illness

• History of bipolar disorder or a psychotic disorder, including schizophrenia
  • NOTE: Depressive disorders are not exclusionary.
• Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases).
  • NOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation
• End stage renal disease requiring renal replacement therapy (dialysis, transplantation).
• Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.
  • NOTE: Localized treatment for skin cancers is not exclusionary.

Lab values

• Diagnosed diabetes mellitus or any previously recorded HbA1c ≥6.5%

Other

• Inability to complete written, informed consent
• Inability to read and understand English as seen on a computer screen
• Incarceration at the time of any study visit
• Pregnancy or breastfeeding during the study.

• HIV-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load.
• Age ≥ 18 years.
• Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to Screening
• Meets the depression definition for this trial:
  • (1) repeat PHQ-9 ≥10100 result at the Screening Visit (suggesting moderate to severe depressive symptoms), AND
  • (2) PHQ-9 depressive disorder diagnosis (2 or more of the 9 depressive symptoms, including depressed mood or anhedonia, present in the past 2 weeks), AND
  • (3) functional impairment (using the tenth PHQ-9 item assessing social/occupational impairment), AND
  • (4) no evidence that the direct physiological effects of a substance, medication, or medical condition clearly account for the depressive symptoms, AND
  • (5) no bipolar or psychotic disorders
  • NOTE: The use of antidepressant medications is not exclusionary.
• HbA1c \< 6.5% at Screening
• HIV-1 RNA level \< 75 copies/mL at Screening
  • NOTE: There are no CD4 cell count eligibility criteria for this trial.