Indianapolis—Jesse C. Stewart, Ph.D., a professor of psychology, and Samir K. Gupta, MD, MS, the David H. Jacobs Professor of Infectious Diseases at IU School of Medicine, have received a National Institutes of Health grant totaling $425,537. The funding will be used to study whether a cognitive behavioral therapy for insomnia (CBT-I) delivered over the internet, known as Sleep Healthy Using the Internet (SHUTi), improves insomnia symptoms and reduces systemic inflammation in people with HIV.
“Insomnia is a significant health issue in people with HIV. Up to 50% of people with HIV report sleep disturbances, including insomnia. These sleep disturbances could be due to the direct effects of HIV on the central nervous system, the side effects of some HIV medications, HIV-related stigma, stress, depression, anxiety, and/or substance use,” explained Stewart.
Systemic inflammation is also thought to contribute to serious non-AIDS events – including diabetes, cardiovascular disease, and cognitive impairment – in people with HIV.
“Successful treatment of insomnia may be one approach to reducing systemic inflammation and ultimately helping to prevent serious non-AIDS events. Fortunately, insomnia is modifiable, with the clear treatment of choice being cognitive-behavioral therapy for insomnia, also called CBT-I,” said Stewart.
Cognitive-behavioral therapy is a well-established and effective therapy for a broad range of mental health conditions. For insomnia, cognitive skills include identifying and changing unhelpful thoughts related to sleep and insomnia. Behavioral skills include developing good sleep habits and making changes to the sleeping environment, typically the bedroom.
Stewart and Gupta are conducting this clinical trial at the Bell Flower Clinic at Eskenazi Health, IUPUI School of Science, and IU School of Medicine. Once screened, participants will attend a baseline visit, at which they will answer several questionnaires to measure their insomnia symptoms and related factors, will have their vital signs measured, and will undergo a blood draw to measure systemic inflammation.
“In our clinical trial, we are examining the effect of 3 months of CBT-I, versus three months of a sleep education condition, on biomarkers in the blood that are signs of systemic inflammation,” said Stewart. “Participants will be randomly assigned, like a flip of a coin, to one of the two sleep treatments – SHUTi or sleep education. To determine the effects of the treatments, participants will attend another visit 12 weeks later and then another visit 24 weeks later, at which the biomarker measures will be repeated.”
SHUTi is an internet CBT program created and tested by Lee Ritterband, Ph.D., and his team at the University of Virginia School of Medicine. SHUTi uses an interactive, multimedia format and can be completed on a desktop computer, laptop, or tablet. SHUTi is structured like and has content very similar to traditional face-to-face CBT-I with a therapist. Ritterband is part of the scientific team conducting this clinical trial.
“In several clinical trials, SHUTi has been proven to be an effective treatment for insomnia, with beneficial effects similar in size to face-to-face CBT-I. Unlike face-to-face CBT-I, SHUTi is convenient and accessible – it can be completed at home at any time,” stated Stewart.
The goal of this study is to show successful treatment of insomnia in people with HIV reduces systemic inflammation.
“Armed with this discovery, Dr. Gupta and I would be ideally positioned to seek funding for a large, definitive, multi-site clinical trial to establish the long-term effects of CBT-I on systemic inflammation and serious non-AIDS events. Ultimately, this line of research could identify a new, practical, and scalable approach to preventing negative health outcomes and improving the quality of life of people with HIV,” said Stewart.
As for the partnership between Stewart and Gupta, it’s beneficial for them and multiple other disciplines.
“Team science is essential for the transdisciplinary, biobehavioral clinical research we conduct. By pooling the complementary expertise and resources across Science, Medicine, and our community clinical partners (e.g., Eskenazi Health), we can formulate innovative ideas and successfully conduct major studies with the potential to advance health-related fields and improve clinical care and public health efforts,” said Stewart.