The iConquerMS community has contributed to many research studies on a wide variety of relevant topics for people with MS, including lifestyle and health outcomes, complementary and alternative medicine, and COVID-19 vaccines. Network members will soon have the opportunity to help evaluate the effectiveness of a new, non-drug treatment for MS fatigue.
ELEVIDA is a software program, produced by GAIA AG, that is used to treat MS fatigue abroad. It serves as a guided therapy session that changes according to individual responses, using concepts from CBT and mindfulness. Users can work through it, answering multiple choice questions at their own pace and the software adapts based on their answers to fit their needs. The program is typically used once or twice per week as a supplement to usual disease modifying therapy.
There is evidence that Cognitive Behavioral Therapy is helpful in relieving MS fatigue. CBT is a form of psychotherapy where people learn to change unhelpful thoughts and actions. The core premise of CBT is that thoughts, feelings and actions are connected. By working on negative thoughts and behaviors, people can feel better and handle challenges more effectively.
In ELEVIDA, information is shared using simulated dialogues. After a quick 5-minute registration, users can begin the first of eight interactive “chats.” These conversations consist of a series of interactive web pages that are tailored to each user based on their traits and answers using predetermined algorithms. All modules are comprised of an introduction and a summary and include homework tasks. Each one takes approximately 30 to 60 minutes to complete.
ELEVIDA Modules
ELEVIDA establishes an individualized fatigue model for each user in the first module that can be adjusted as needed. The software includes instructions for using the program effectively and sections devoted to commonly asked questions, management of usernames and passwords, references (with research articles from the program) and technical support. It offers the option of receiving daily text messages, which reinforce concepts discussed in the “chats,” encourage user participation and serve as reminders of the program’s availability.
In 2018, researchers in Germany evaluated ELEVIDA’s effectiveness at reducing fatigue in people with MS. They divided 275 participants with MS and fatigue into two groups. One group was treated with ELEVIDA in addition to standard care for 12 weeks, while the other received regular care only. The ELEVIDA group experienced less fatigue than the control group. Data showed using ELEVIDA also made their quality of life better, they felt less anxious and they could do daily tasks more easily. These improvements lasted for 6 months, suggesting they learned skills to manage fatigue even after the program ended. In 2021, this study served as the basis for ELEVIDA’s approval in Germany to treat MS-related fatigue.
ELEVIDA is the only CBT for MS-related fatigue to be approved and reimbursed anywhere in world.
ACP recently received a Clinical Trial Award from the Department of Defense Office of the Congressionally Directed Medical Research Programs (CDMRP) to conduct the CAFE-MS (Confirmatory Trial for Alleviating Fatigue with Elevida in Multiple Sclerosis (MS)) clinical trial. This project is inspired by the positive results seen in the German study. Stay tuned for the press release in the near future!
What are the main goals of CAFE-MS?
CAFE-MS participants will be recruited from the iConquerMS network and the Veterans Health Administration MS Centers of Excellence (VA). This approach will help to ensure the participation of less represented groups in the study, including those with diverse backgrounds, living in rural areas and having disabilities. Our preliminary survey is now available for those who would like to provide input on the study design. Recruitment will begin in March 2024.
The MS population at the VA differs from the broader MS population in the US. This group includes 47.5% White men, 20.7% White women, 13.4% Black men, 11% Black women, and 7.5% from other racial and ethnic backgrounds.
What are the inclusion criteria for CAFE-MS?
Participants will be randomly assigned to receive treatment via ELEVIDA, other online educational materials, or standard of care only.
A Steering Committee with diverse membership will be established to oversee all aspects of this project. It will include people affected by MS, healthcare providers, researchers and MS clinical trial experts. As we do with all iConquerMS research projects, we are currently surveying the iConquerMS community to gather their insights on the study in advance of it launching.
Digital tools like the ELEVIDA program can be expanded more easily than in-person clinic treatments making them promising for improving healthcare, especially for those who can’t easily travel to a doctor’s appointment due to distance or other reasons. iConquerMS will play a pivotal role evaluating ELEVIDA’s effectiveness and suitability across diverse groups of people with MS and in different settings. This clinical trial, which will be conducted with the goal of gaining FDA approval, aims to significantly advance the field by providing a much-needed, effective treatment for MS-related fatigue. If results show that ELEVIDA works for different MS groups, is accepted by fatigued individuals with MS, and is better than the current standard, it could be FDA approved and covered by insurance in the United States. Having an approved and reimbursed therapy for MS-related fatigue would be a significant breakthrough for everyone affected by MS, as well as their healthcare providers. Stay tuned!
Want to steer the direction of MS research and get more involved in projects like this, that significantly impact people affected by MS? If you haven’t already, please consider joining iConquerMS today!
