A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis

Treatment of MS-related fatigue represents a significant challenge in providing symptomatic therapy for people with MS. In 1998 the MS Council for Clinical Practice Guidelines published Fatigue and MS, the first evidence based treatment guideline for MS recommending comprehensive treatment for fatigue. This guideline is widely distributed, but does not include a program for implementation. Fatigue: Take Control, is the first formal program modeled on the MS fatigue guidelines. This proposal entails performing a four-center single blind intent-to-treat randomized controlled two-arm parallel design trial of Fatigue: Take Control with MS participants to accomplish three Specific Aims. Specific Aim #1: Demonstrate that Fatigue: Take Control reduces fatigue in people with MS who are ambulatory and not depressed at the end of the intervention and at three and six months after the intervention compared to a general MS group education program. The primary outcome measure will be the Modified Fatigue Impact Scale (MFIS) chosen for its multi-dimensional nature, recommended use in the Fatigue and MS guideline and sensitivity to change in the pilot study. Specific Aim #2: Demonstrate that Fatigue: Take Control increases self-efficacy in people with MS who are ambulatory and not severely depressed. Fatigue affects a person's sense of control over his/her life. The investigators will use the MS Self Efficacy Scale (MSSE) for this secondary objective. This measure also demonstrated improvement in the pilot study. Specific Aim #3: Demonstrate that Fatigue: Take Control results in changes in medication utilization, exercise participation, sleep and health-related quality of life in people with MS who are ambulatory and not depressed. Fatigue affects body functions/structure, activity and participation in all aspects of daily life. Fatigue: Take Control was created with the expectation that fatigue can be reduced by guiding individuals to make the environmental, behavioral and lifestyle changes necessary to manage MS fatigue. This objective will explore important secondary causes of fatigue that impact health-related quality of life by identifying participant changes in: timed walk using the time to walk 25 feet (T25-FW), medication utilization using a self-report medication diary, exercise participation using the self-report Rapid Assessment of Physical Activity (RAPA), sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and changes in overall health-related quality of life using the SF-36.