RecruitingNot Applicable

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

United States150 participantsStarted 2026-04-10

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Inability to complete written, informed consent * Inability to read and understand English as seen on a computer screen * Diagnosed diabetes mellitus or any previously …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in HOMA-IR at 24 weeks

Timeframe: 24 weeks

Trial details

NCT IDNCT07226128

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-06-30

Contact for this trial

Danielle Grounds, RVT

1-317-278-0255 diground@iu.edu

View on ClinicalTrials.gov More HIV trials