A Randomized, Controlled Trial Assessing the Effects of Cognitive Behavioral Therapy to Prevent Worsening Insulin Resistance in Depressed, Virologically-Suppressed, Antiretroviral-Treated Adults With HIV
The goal of this clinical trial is to learn if depression treatment improves insulin resistance, or how the body uses insulin to lower blood sugar, in people with HIV on HIV treatment. Researchers will compare an internet-based (online) depression treatment program called cognitive behavioral therapy with depression education. In the online group, participants will undergo 9 weekly treatment sessions. The education group will receive learning materials about depression and will be monitored every month. All participants will have 4 study visits over 12 months.
• 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.