The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
Qualifiers
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
(1) repeat PHQ-9 ≥10100 result at the Screening Visit (suggesting moderate to severe depressive symptoms), AND
Disqualifiers
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
Trial design
Treatments tested in this trial
- Internet cognitive behavioral therapy (iCBT-D)
- Active Control (AC)
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Indiana University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov