Earlier this year, researchers at the Medical College of Georgia (MCG) at Augusta University received a $2.5 million grant from the National Institutes of Health to investigate the connection between insomnia and depression. The study, called the Assessing Improvements in Mood and Sleep (AIMS) Trial, is now seven months into its five-year timeline.
Research over recent decades has shown that insomnia and depression are closely linked, with each condition potentially causing or worsening the other. An article in Current Psychiatry Reports notes that people with insomnia are five times more likely to experience anxiety or depression symptoms than those without sleep problems. This issue affects people of all ages worldwide.
To address this link, MCG collaborated with the University of Pittsburgh and the University of California, Los Angeles to develop the AIMS Trial. William Vaughn McCall, MD, professor emeritus at MCG’s Department of Psychiatry and Health Behavior and principal investigator for the study, explained: “Ultimately, the hope is to find other avenues to reduce the risk for depression and depression symptoms.”
In 2019, Dr. McCall’s team published research showing that zolpidem (Ambien), a prescription sleep aid, reduced symptoms of insomnia, depression, and suicidal ideation among outpatients. Following these results, new efforts have focused on non-drug approaches. “After that paper came out, there were a variety of groups around the country that wanted to go in a different direction and see if the same results can be achieved without pills, which is what we’re doing in this trial,” McCall said.
The current AIMS Trial uses psychotherapy instead of medication to help patients identify and change patterns related to sleep issues. “The present study is riffing off of all this prior literature about an association between sleep problems and depression symptoms. Our prior work showed that drug therapy of insomnia may reduce depression symptoms, but we’re now moving it to a different modality in the form of psychotherapy intended to address sleep problems in a focused group of older patients,” McCall said.
He added: “One form of psychotherapy is called Cognitive Behavior Therapy for Insomnia, or CBTI. But there are broader applications of sleep psychotherapies that go beyond what CBTI is interested in, and we are comparing these different approaches.”
Savannah Makowski serves as site therapist for MCG’s portion of the study: “It’s a very structured eight-week protocol, and we work through very specific skills with their sleep.” Jessica Britt-Thomas, PhD—associate professor in Family and Community Medicine as well as Psychiatry and Health Behavior—added: “To expand, the psychotherapies used in this study are skills-based interventions that are individualized to the participants’ presenting concerns.”
Details about how exactly participants will be treated remain confidential so as not to affect outcomes.
The grant was awarded earlier this year after years spent preparing for such an opportunity. Laryssa McCloud, PhD—research manager at MCG—said: “We were ecstatic because you put these things in so far in advance, and then we got a late notification that the grant had been approved… We were very, very happy.”
Alongside Augusta University (AU), UCLA and Pitt serve as test sites; Pitt acts as parent site for coordination purposes. So far AU has enrolled 14 participants aged 55 or older who have both diagnosed depression (and are on antidepressants) but continue experiencing symptoms.
Participants can join either by coming into MCG’s psychiatry department or remotely from home. Recruitment relies on referrals within AU departments as well as flyers posted throughout hospital facilities. According to McCloud: “It’s mostly with referrals to our psychiatry department… We also have groups that we are working with to screen people who may be a part of their group… We also have flyers around hospital.” Dr. McCall added: “We’re really open to receiving information from any sources about possible participants… I wouldn’t turn down a phone call from anybody who thought they or their loved one might benefit from being in this study.”
Each participant undergoes eight weeks of therapy followed by five months’ follow-up assessments conducted by research assistants like Joely Fields: “They have assessments that are done throughout the study… then we see how they’re doing as they progress.”
The goal across all three sites is enrollment totaling 140 participants per location over five years; each individual takes part for about seven months while overall recruitment continues throughout project duration.
Dr. McCall noted future plans include expanding partnerships statewide: “We are hopeful that this study… will allow a relationship with Wellstar to allow us to treat patients across state inside this research protocol… That would be exciting and potentially exemplary for other studies…”
