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Cognitive Behavioral Therapy for Insulin Resistance in People with HIV

This study is looking at whether treating depression can improve insulin resistance (how your body uses insulin to manage blood sugar) in people living with HIV. Researchers will compare an online program called Internet Cognitive Behavioral Therapy (iCBT-D) with depression education. If you join the iCBT-D group, you'll have 9 weekly online sessions. If you're in the education group, you'll get learning materials about depression and have monthly check-ins. All participants will have 4 study visits over 12 months. The main goal is to see if there's a change in insulin resistance after 24 weeks. You can join if you are 18 or older and have a documented HIV-1 infection. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 150 participants. It compares an online therapy program to depression education.
What's involved
You will have 4 study visits over 12 months. Depending on your group, you will either have 9 weekly online treatment sessions or receive depression education and monthly monitoring.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 24 weeks, but participants will have study visits over 12 months.

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NCT07226128

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

Recruiting
NAAges 18+InterventionalTreatment
Indiana University
~150 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Internet cognitive behavioral therapy (iCBT-D)Active Control (AC)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in HOMA-IR at 24 weeks
Measured over 24 weeks

Conditions

HIV
Depression in Adults
Insulin Resistance
Cognitive Behavior Therapy

Explore related trials

DepressionHIV InfectionInsulin Resistance

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Samir K Gupta, MD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

Danielle Grounds, RVT
[email protected]
1-317-278-0255
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
HbA1c \< 6.5% at Screening
HIV-1 RNA level \< 75 copies/mL at Screening

Exclusion

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
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).
End stage renal disease requiring renal replacement therapy (dialysis, transplantation).
Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.
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

What this trial measures

  • Change from baseline in HOMA-IR at 24 weeks24 weeks

    Homeostasis Model Assessment-Insulin, where higher values indicate greater insulin resistance