RecruitingNot applicable

The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits
  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All participants will have 4 study visits over 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether treating depression helps the body use insulin to lower blood sugar in adults with HIV who take HIV medicine. It compares an online talk therapy program with depression education. The online group has 9 weekly sessions, and everyone has 4 study visits over 12 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older and have HIV-1 confirmed in your medical record.
  • You have been on a stable HIV treatment plan for at least 180 days before screening.
  • You meet the study's depression rules, based on a questionnaire, symptoms over the past 2 weeks, and problems with daily life.
  • Your depression symptoms are not clearly caused by a substance, medicine, or another health condition. Taking antidepressants is allowed.
  • Your HbA1c, a blood test that shows average blood sugar, is below 6.5% at screening.
  • Your HIV blood level is below 75 copies/mL at screening. There is no required CD4 immune cell count.

Who can't join

  • You cannot give written consent or read and understand English on a computer screen.
  • You have diabetes or have ever had an HbA1c result of 6.5% or higher.
  • You have a history of bipolar disorder or a psychotic disorder, such as schizophrenia; have an active suicide risk at study entry; or have drug use that would prevent you from following study rules.
  • You are in jail or prison at any study visit, or are pregnant or breastfeeding during the study.
  • You have another illness that causes body-wide inflammation, such as lupus or inflammatory bowel disease. Hepatitis B or C is allowed, but hepatitis C treatment is not allowed during the study.
  • You have kidney failure needing dialysis or a transplant, or known or suspected cancer needing whole-body treatment within 180 days of study entry. Local treatment for skin cancer is allowed.
  • You received treatment for a serious illness within 14 days before study entry. Such treatment during the study may delay visits or end your participation.
  • At study entry, you take experimental drugs, cell-killing chemotherapy, medicines that suppress the immune system throughout the body, whole-body steroids, or muscle-building steroids. Exceptions include normal-level testosterone replacement and skin steroids. Inhaled or nasal steroids are allowed only if you do not take HIV protease inhibitors. Aspirin and NSAID pain medicines are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (1)

IN