A clinical trial testing a computer program called Deprexis as a home-based therapeutic strategy for multiple sclerosis (MS)-related depression is enrolling participants with all types of MS at three sites in the U.S. and two in Germany.
The U.S. study locations are the Cedars-Sinai Medical Center, in Los Angeles, California, the University of Missouri, Kansas City, and Penn State University, in Pennsylvania. Trial locations in Germany are the Charité University, in Berlin, and University Medical Center Hamburg-Eppendorf.
According to a press release from the National MS Society, which is supporting the trial (NCT02740361), about 400 adults (aged 18-65 years) with symptoms of depression will be recruited. All participants will be required to undergo two separate clinical assessments at their study site, and need to have internet access at home.
Depression is a common symptom in people with MS, and has been associated with decreased quality of life, absence from work, and is among the strongest predictors for suicidal thoughts in this patient population.
According to researchers, depression in MS remains underdiagnosed and often untreated. MS patients, in turn, may face challenges to attend sessions with a psychotherapist due to other MS symptoms such as walking difficulties, cognitive problems, and fatigue. Furthermore, there is limited availability of psychotherapists.
Deprexis, developed by Gaia, is a digital, self-guided, internet-based training program to help overcome MS-related depression.
A small trial (NCT01663649) conducted by Stefan Gold, PhD, the study’s lead investigator, showed that the fully-automated Deprexis tool could be beneficial. It eased depression symptoms in MS patients, and significantly improved patients’ quality of life, while eliminating the need to travel for therapy
Now, in a larger-scale trial, participants will be randomly assigned to one of three groups: one will have access to the web-based Deprexis for three months; another will receive Deprexis and regular email support once weekly for three months (a combination called DeprexisPlus); and the third group (control) will receive only Deprexis after six months.
The trial’s primary outcome measure is the Beck Depression Inventory-II, a clinical scale of depression. Other outcomes include measures of quality of life, fatigue, cognitive function, and a questionnaire on suicidal behavior. Patients will be assessed at study start, and after three, six and 12 months. While the first two assessments require a visit to a study site, the last two — intended as long-term follow-up — are completed online.
Overall, the study has three main goals: to test the effectiveness of Deprexis as a therapy for MS-related depression; to determine whether DeprexisPlus provides greater benefits; and to assess if the benefits are durable, as well as whether a booster session helps increase this durability.
Earlier this year, Gaia announced its program was adopted by the health system of the United Arab Emirates.