A Randomized, Controlled Trial Assessing the Effects of Cognitive Behavioral Therapy to Prevent Worsening Insulin Resistance in Depressed, Virologically-Suppressed, Antiretroviral-Treated Adults with Hiv
Study on Therapy for Depression in People with HIV
Samir Gupta, MD
Primary Investigator
Brief description of study
The purpose of this study is to determine if treating depression (or feelings of sadness or hopelessness with little interest or pleasure in doing things) in people with HIV will decrease the risk of developing diabetes, specifically through reducing insulin resistance. Insulin resistance means the body does not use the insulin hormone effectively to keep blood sugar levels normal.
Detailed description of study
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. These participants will be ≥ 18 years old, have been receiving antiretroviral therapy for at least 180 days with an HIV viral load
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: HIV-1 Infection, Depression
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Age: 18 years - 100 years
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Gender: All
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.
If participants are excluded due to the above criteria, they may be approached again in the future or have their study visit rescheduled within the allowable timeframe if these criteria are no longer applicable.
This study investigates how treating depression in people with HIV might affect insulin resistance, which is when the body doesn't use insulin effectively to control blood sugar. The study focuses on adults with HIV who are already on antiretroviral therapy and are experiencing depression. The purpose is to see if improving depression can also improve how the body uses insulin.
Participants in the study will be divided into two study arms. One group will receive an online cognitive behavioral therapy program, consisting of 9 weekly sessions. The other group will receive educational materials about depression and be monitored monthly. There will be 4 study visits over a year to track progress.
- Who can participate: Adults aged 18 and older with documented HIV-1 infection, stable on antiretroviral therapy, and experiencing moderate to severe depressive symptoms may participate. Participants must not have diabetes, bipolar disorder, or psychotic disorders.
- Study details: Participants will either take part in an online therapy program or receive educational materials about depression. The online therapy involves weekly sessions, while the education group will have monthly check-ins.
- Study timelines and visits: The study will last 12 months. The study requires 4 visits.