Online cognitive behavioral therapy to improve 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

This trial will test whether an online cognitive behavioral therapy program for adults with HIV and depression can improve how their bodies respond to insulin.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Indiana University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT07226128 on ClinicalTrials.gov

What this trial studies

Adults with HIV who are on stable antiretroviral therapy and meet the trial's depression criteria will be randomized to either an internet-based cognitive behavioral therapy program (9 weekly sessions) or an active control that receives depression education with monthly monitoring. All participants will attend four study visits over 12 months to measure insulin resistance and other clinical outcomes. The primary comparison will be change in insulin sensitivity between the iCBT and education groups. Participants must be able to use the online program and attend in-person visits at the study site.

Who should consider this trial

Good fit: Adults living with HIV who are on stable antiretroviral therapy, have depressive symptoms meeting the trial's PHQ-9 criteria, and can use an online CBT program and attend study visits are ideal candidates.

Not a fit: People without clinically significant depression, those not on stable HIV treatment, individuals with medical conditions driving insulin resistance, or those unable to use internet-based programs are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, this could provide a scalable, non-drug way to lower insulin resistance and reduce diabetes risk in people with HIV who have depression.

How similar studies have performed: Cognitive behavioral therapy has improved depression and some metabolic measures in other populations, but applying internet-based CBT to reduce insulin resistance in people with HIV is relatively novel and not yet well-established.

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.

Where this trial is running

Indianapolis, Indiana

• Indiana University Health — Indianapolis, Indiana, United States (RECRUITING)

Study contacts

• Principal investigator: Samir K Gupta, MD — Indiana University
• Study coordinator: Danielle Grounds, RVT

Conditions: HIV, Depression in Adults, Insulin Resistance, Cognitive Behavior Therapy, hiv, depression, insulin resistance, diabetes