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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Intervention participants will receive the empirically supported, HIPAA-compliant, therapist-assisted iCBT-D called Good Days Ahead (GDA; MindStreet, Inc.). GDA uses an interactive, multimedia format (including video, exercises, calls to action, newsfeeds, and customized feedback) to deliver nine 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT. Topics include identifying and modifying automatic thoughts, using behavioral activation and other behavioral methods, identifying and modifying schemas, using effective coping strategies, and employing other core CBT methods.
Our AC comparator will include depression education and depressive symptom monitoring along with usual depression care as provided by the participants HIV clinicians. Trial staff will fist have a 30-minute call with AC participants to review depression materials, including their HIV provider's role in its management and treatment options and also provide a list of local mental health services. There are no care restrictions by the primary HIV clinicians. Trial staff will call AC participants every 4 weeks to assess depressive symptoms (PHQ-9) and will notify clinic staff to encourage additional care when indicated.
Indiana University Health
Indianapolis, Indiana, United States
RECRUITINGChange from baseline in HOMA-IR at 24 weeks
Homeostasis Model Assessment-Insulin, where higher values indicate greater insulin resistance
Time frame: 24 weeks
Change from baseline in circulating sCD14 at 24 weeks
sCD14 is a blood measure of inflammation, where higher levels indicate greater amounts specifically of monocyte activation
Time frame: 24 weeks
Change from baseline in circulating REG3a at 24 weeks
REG3a is a blood measure of gut integrity, where higher levels indicate greater amounts of gut wall breakdown
Time frame: 24 weeks
Change from baseline in circulating 16S rDNA at 24 weeks
16S rDNA is a measure of small amounts of bacteria in the blood that typically cannot be grown on blood cultures, where higher amounts indicate more bacteria in the bloodstream
Time frame: 24 weeks
Changes from baseline in circulating b-D-glucan at 24 weeks
b-D-glucan is a measure of small amounts of fungus in the blood that typically cannot be grown in fungal cultures, where higher amounts indicate more fungus in the bloodstream
Time frame: 24 weeks
Change from baseline in HOMA-IR at 48 weeks
Homeostasis Model Assessment-Insulin, where higher values indicate greater insulin resistance
Time frame: 48 weeks
Change from baseline in HbA1c at 24 weeks and 48 weeks
HbA1c (hemoglobin A1c) is a measure of average blood sugar control over 3 months
Time frame: 24, 48 weeks
Change from baseline in glycated albumin at 24 weeks and 48 weeks
Glycated albumin is a measure of average blood glucose control over 1 month
Time frame: 24, 48 weeks
Change from baseline in circulating sCD163 at 24 weeks
sCD163 is a measure of inflammation, where higher levels indicate greater macrophage activation
Time frame: 24 weeks
Change from baseline in PC(P-16:0/18:2) levels at 24 weeks
PC(P-16:0/18:2) is a cell metabolite, where higher levels indicate greater insulin resistance
Time frame: 24 weeks
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