iConquerMS is planning a new study of a therapy to help with fatigue in MS, and would value your input. Please read the description of the study below and answer the questions that follow.
Introduction
This proposed study seeks to determine if an online Cognitive Behavioral Therapy (CBT) program called ELEVIDA reduces fatigue in people with MS living in the US. The name of this study is CAFE-MS, which stands for “Confirmatory Trial for Alleviating Fatigue with Elevida in Multiple Sclerosis (MS).”
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.
Study description:Who is conducting the study?
The study is being conducted by the iConquerMS team, in partnership with researchers from Charité (a German university hospital), the University of Gottingen, GAIA AG (the German company that developed ELEVIDA), and the US Veterans Administration. The steering committee for CAFE-MS will include people affected by MS, healthcare providers, researchers and MS clinical trial experts.
What is the purpose of the study?
There is evidence that Cognitive Behavioral Therapy is helpful in relieving MS fatigue. Normally, CBT is provided through working with a CBT therapist. GAIA developed the ELEVIDA program to provide CBT to people with MS in a convenient, accessible, online format.
A clinical trial in Germany found that ELEVIDA was effective in reducing fatigue in people with MS. The CAFE-MS study will determine whether a version of ELEVIDA adapted for American users is similarly effective in treating fatigue. The trial will be conducted with the oversight of the FDA in order to gain FDA approval and make it possible for ELEVIDA to be covered by insurance.
Another goal of the study is to see how ELEVIDA works in subgroups of the MS population that haven't traditionally been included in research studies, including racial and ethnic minority groups, people living in rural locations, and people with disabilities. We will make special efforts to recruit people in these groups to participate in CAFE-MS.
How could the results benefit people with MS?
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.
What will happen in the study? How will iConquerMS members be involved?
People who are interested in participating in CAFE-MS will be asked to provide some initial information to ensure that they are eligible for the study and to assess their level of fatigue at the start of the study.
Eligible participants will be randomly assigned to one of these groups:
- Use of the ELEVIDA program, plus treatment as usual
- Access to an evidence-based information program, plus treatment as usual
- Treatment as usual
Participants who are assigned to Group 1 will be given an account on the ELEVIDA website and will be asked to access the program once or twice a week over 6 months. ELEVIDA consists of modules focusing on different topics such as activity, sleep, and stress. These modules, which include information and instruction, automated interactive "chats," and homework, are tailored to each user. Group 2 participants will be given access to a website with several informational modules about fatigue and its management. Group 3 will continue with their usual treatment.
After 6 months, participants in Group 2 can choose to access the ELEVIDA program, and participants in Group 3 can choose to access either the ELEVIDA program or the evidence-based information program, if they wish.
Participants will be asked to complete surveys about their fatigue and other topics throughout the study, with the last set of surveys taking place 12 months from the start of the study. Participants will be paid up to $120 for completing the study activities.
Who is providing the funding for the study?
The US Department of Defense is providing the funding for this study through its Congressionally Directed Medical Research Program.