Actively Recruiting
The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV
Led by Indiana University · Updated on 2026-04-15
150
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV-1 infection confirmed by approved tests or viral load measurements
- Age 18 years or older
- Stable antiretroviral therapy for at least 180 days before screening
- Moderate to severe depression defined by repeated PHQ-9 scores and functional impairment
- No bipolar or psychotic disorders
- HbA1c less than 6.5% at screening
- HIV-1 RNA viral load less than 75 copies/mL at screening
You will not qualify if you...
- Unable to provide written, informed consent
- Unable to read and understand English on a computer screen
- Diagnosed diabetes mellitus or previous HbA1c 6.5% or higher
- History of bipolar or psychotic disorders including schizophrenia
- Incarceration during any study visit
- Active suicidality at entry as assessed by HIV provider or social worker
- Diseases causing increased systemic inflammation other than HIV
- End stage renal disease requiring dialysis or transplant
- Known or suspected cancer needing systemic treatment within 180 days
- Therapy for serious illnesses within 14 days before entry visit
- Pregnancy or breastfeeding during the study
- Use of investigational drugs, chemotherapy, systemic immunosuppressants, systemic glucocorticoids, or anabolic steroids at entry
- Active drug use or dependence affecting study adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
D
Danielle Grounds, RVT
CONTACT
R
Rory Duplantier, ANP-PC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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