Cognitive Behavior Therapy, Depression in Adults, HIV, Insulin Resistance
Conditions
Keywords
hiv, depression, insulin resistance, diabetes, cognitive behavioral therapy
Brief 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.
Interventions
BEHAVIORALInternet cognitive behavioral therapy (iCBT-D)
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.
BEHAVIORALActive Control (AC)
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.
Sponsors
Indiana University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 recorded HbA1c ≥6.5% * History of bipolar disorder or a psychotic disorder, including schizophrenia NOTE: Depressive disorders are not exclusionary. * 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). NOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation * End stage renal disease requiring renal replacement therapy (dialysis, transplantation). * Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit. NOTE: Localized treatment for skin cancers is not exclusionary. • Therapy for serious medical illnesses within 14 days prior to the Entry Visit NOTE: Therapy for serious medical illnesses that overlaps with a study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation. * 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 NOTE: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors NOTE: Use of NSAIDS and aspirin are allowed • Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HOMA-IR at 24 weeks | 24 weeks | Homeostasis Model Assessment-Insulin, where higher values indicate greater insulin resistance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HbA1c at 24 weeks and 48 weeks | 24, 48 weeks | HbA1c (hemoglobin A1c) is a measure of average blood sugar control over 3 months |
| Change from baseline in glycated albumin at 24 weeks and 48 weeks | 24, 48 weeks | Glycated albumin is a measure of average blood glucose control over 1 month |
| Change from baseline in circulating sCD163 at 24 weeks | 24 weeks | sCD163 is a measure of inflammation, where higher levels indicate greater macrophage activation |
| Change from baseline in PC(P-16:0/18:2) levels at 24 weeks | 24 weeks | PC(P-16:0/18:2) is a cell metabolite, where higher levels indicate greater insulin resistance |
| Change from baseline in circulating sCD14 at 24 weeks | 24 weeks | sCD14 is a blood measure of inflammation, where higher levels indicate greater amounts specifically of monocyte activation |
| Change from baseline in circulating REG3a at 24 weeks | 24 weeks | REG3a is a blood measure of gut integrity, where higher levels indicate greater amounts of gut wall breakdown |
| Change from baseline in circulating 16S rDNA at 24 weeks | 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 |
| Change from baseline in HOMA-IR at 48 weeks | 48 weeks | Homeostasis Model Assessment-Insulin, where higher values indicate greater insulin resistance |
| Changes from baseline in circulating b-D-glucan at 24 weeks | 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 |
Countries
United States
Contacts
CONTACTDanielle Grounds, RVT
CONTACTRory Duplantier, ANP-PC
PRINCIPAL_INVESTIGATORSamir K Gupta, MD
Indiana University
Outcome results
None listed