Many individuals with multiple sclerosis (MS) suffer from fatigue, which is often their most disabling symptom. Treatments for MS fatigue are limited, so it is important to maximize the effectiveness of available therapies, which should include tailoring the treatment to the individual. Unfortunately, healthcare providers have little information to help guide them when they are creating a fatigue treatment program for a patient with MS and fatigue. For example, providers have little information to help them decide whether a single therapy, such as a medication or behavioral therapy, will be enough for a given patient, or whether therapies should be combined to provide the best results.
This clinical trial, which will be guided by feedback from MS patients, MS providers, community organizations, and payers, will compare the effectiveness of a commonly used behavioral treatment strategy (cognitive behavioral therapy), a commonly used medication (modafinil), and a combination of both therapies for fatigue in a large, representative group of patients with MS. Fatigue will be measured with a combination of patient-centered survey measures as well as measures of physical activity and fatigue, which will be collected with a wrist-worn device as study participants go about their day. These measures will open a window into the day-to-day experiences of patients with MS, before and after treatment. The effects of other conditions and problems that are common in MS (depression, sleep disturbances, and disability), on response to each of the different treatments will also be assessed, which will be particularly helpful in terms of giving providers more information on how to tailor fatigue intervention plans to patients’ individual circumstances and needs. Other factors related to the patient experience with these different treatments, such as how well people in each treatment condition followed the treatment program (treatment adherence) and whether patients experienced any negative side effects, will be assessed. Results of this study will help patients, providers, and policy makers determine which patients with fatigue respond best to cognitive behavioral therapy or modafinil, and which MS patients may benefit most from a combination of these treatments.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.