Real-World Clinical Trial of an Online Cognitive Behavioral Therapy for Managing Fatigue in Multiple Sclerosis
Abstract
Up to 70% of people with multiple sclerosis (MS) report fatigue as their worst and most troubling symptom. To date, studies that use drugs to treat MS fatigue have yielded inconclusive and/or negative results on their effectiveness. Real World Clinical Trial of an Online Cognitive Behavioral Therapy for Managing Fatigue in MS is a study designed to test an intervention that does not rely on drugs. The fatigue treatment being studied is Elevida, which has been rigorously studied and is approved and reimbursed for use in Germany. Elevida is an MS-specific fatigue management program based on cognitive behavioral therapy (CBT) delivered via the internet. CBT is a psychology tool that helps a person connect their physical symptoms with their emotional reactions and cognitive thinking and has been proven effective for treating a wide range of conditions including depression, pain, and anxiety. Internet-based interventions such as Elevida could provide treatment for people with MS who might not have access to providers due to their location, transportation, or mobility problems or who lack the financial resources for personalized therapy sessions. This is a real-world large-scale clinical trial of 2,000 people that will look at the results in key subgroups of women, men, racial, and ethnic subgroups. The participants will be randomly assigned to one of three groups. All study participants will continue with their treatment as usual, and no one will be asked to change their usual MS treatments. The first group will continue treatment with no additional intervention offered. The second group will continue their usual treatment with the addition of internet-based resources about MS and fatigue. The third group will continue with treatment as usual combined with the Elevida program. This study will be conducted over a period of 3 months with all participants being asked to complete online assessment tools at regular intervals to demonstrate the effectiveness of each treatment. Positive results from this study would provide compelling evidence for support and reimbursement of Elevida in the U.S. as an effective MS fatigue treatment that can reach areas where therapists are unavailable or provide care in settings with limited resources. Study participants will come from the Veterans Administration MS Centers of Excellence and the iConquerMS network, a division of the Accelerated Cure Project for MS.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310482
Entities
People
- Robert Mcburney
Organizations
- United States Army