eIMPACT-DM
Pilot Trial

HIV-Insomnia
Pilot Trial

People with depression are at increased risk of diabetes. The primary aim of this R21 pilot trial is to reduce the diabetes risk of people with depression by comparing a control group receiving current primary care for depression to an intervention group receiving an updated version of collaborative care for depression called eIMPACT-DM. The secondary aim is to explore whether somatic depressive symptoms moderate the effect of eIMPACT-DM on diabetes risk markers.

 

64 patients with depression and elevated diabetes risk are being recruited from the primary care clinics of Eskenazi Health, a safety net healthcare system in Indianapolis. The primary outcome is hemoglobin A1c, and the secondary outcome is insulin resistance measured by Homeostatic Model Assessment (HOMA-IR).

 

This trial could pave the way for an R01-level RCT which could then identify a novel target (depression) for diabetes primary prevention efforts and equip healthcare providers with a new tool (eIMPACT-DM) to manage the diabetes risk of their patients. It is our long-term hope that treating depression in primary care will reduce the disability and death caused by diabetes.

 

This is a 2-year study funded by the National Institute of Diabetes and Digestive and Kidney Diseases

ClinicalTrials.gov Entry

Due to the success of HIV medications (highly effective antiretroviral therapy), people with HIV are living longer, and HIV is now considered to be a chronic disease. Unfortunately, people with HIV have an increased risk of serious non-AIDS events (SNAE) including diabetes, chronic kidney disease, and cardiovascular disease (CVD). The causes of this elevated CVD risk are not fully understood.

 

The aim of this R21 pilot trial is to determine whether treating insomnia with an internet cognitive-behavioral treatment for insomnia (CBT-I) called Sleep Healthy Using the Internet (SHUTiTM) lowers systemic inflammation in people with HIV.

 

50 patients with treated HIV and insomnia are being recruited from HIV clinics in Indianapolis. The primary outcome is change in circulating levels of high-sensitivity C-reactive protein (hsCRP), and the secondary outcomes include IL-6, sCD14, and sCD163.

 

Results of this phase II trial could pave the way to a multicenter phase III trial, which could identify insomnia as a novel treatment target for SNAE prevention and establish the long-term effects of SHUTi on systemic inflammation and SNAE.

 

This is a 2-year study funded by the National Institute of Mental Health

ClinicalTrials.gov Entry

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