The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Indiana University
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
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).
Where it's recruiting
Indianapolis
Source: ClinicalTrials.gov · NCT07226128 · last updated 2026-06-02