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

Recruiting now · Not applicable

Conditions studied: HIV, Depression in Adults, Insulin Resistance, Cognitive Behavior Therapy

In brief

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.

Key facts

Study ID: NCT07226128
Run by: Indiana University
People needed: 150
Starts: 2026-04-10
Expected to finish: 2031-06-30
Last updated by the study team: 2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Inability to complete written, informed consent
Inability to read and understand English as seen on a computer screen
Diagnosed diabetes mellitus or any previously recorded HbA1c ≥6.5%
History of bipolar disorder or a psychotic disorder, including schizophrenia
NOTE: Depressive disorders are not exclusionary.
Incarceration at the time of any study visit
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).
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.
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.
Pregnancy or breastfeeding during the study.
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.

Where it is running

Indiana University Health — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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