No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for
This trial is looking for adults with HIV who are experiencing depression. Participants will receive 9 weeks of online therapy to see if it can improve how their body uses insulin.
I have been on HIV treatment for at least 6 months
I have moderate to severe depressive symptoms
I have an HbA1c less than 6.5%
I have an HIV-1 RNA level less than 75 copies/mL
You may not be able to join if
I cannot understand or read English
I have a history of bipolar disorder or psychotic disorder
I have diagnosed diabetes
I am currently pregnant or breastfeeding
I recently received treatment for a serious illness
I have active drug use or dependence
I am currently in jail
I have an active risk for suicide
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 sessi…
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.
Trial Locations
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Eligibility Criteria
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 …
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.
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