Multiple Sclerosis Clinical Trial
Official title:
A Randomized Controlled Trial of e-Support in Persons With Multiple Sclerosis
Primary objectives:
- To determine the feasibility of program (80% retained with 75% overall attendance, and
completed immediate follow-up questionnaires from 75% of participants).
- To determine the efficacy of program (evaluated by decreased loneliness, operationalized
as decreased total score on the UCLA Loneliness Scale from pre to post intervention).
Secondary objective:
- To determine whether program will affect depression and quality of life.
This study involves prospective data collection from an intervention to investigate the
impact of participation by MS patients in a 12-week guided online social support group. All
outcomes will be compared to active control group. At the completion of a 12-week interval,
all participants (placebo and treatment) will complete follow-up questionnaires. Three months
after completing, participants will be sent follow-up questionnaires that will be evaluated
as a 6-month follow-up, to assess retention of benefits.
Social support has been linked to better health outcomes in many clinical populations.
Multiple sclerosis (MS), a chronic neurological disease that affects over 400,000 people in
the United States, involves physical and cognitive disability that can have negative
consequences on social integration. This can lead to social isolation, which may be
dynamically related to depression, fatigue, and disease progression. The aim of the present
study is to investigate the impact of support group involvement on persons with MS. Outcomes
of interest include mood, loneliness, and quality of life (QOL). Many people with MS feel
isolated and are unable to participate in support groups that meet in locations that may be
far from home, difficult to travel to (due to physical disability or lack of resources), or
may not be convenient for their schedules. Another hindrance is the apprehension that MS
patients sometimes experience when they encounter patients with severe physical disability,
or worse impairment than their own. For these reasons, the study is introducing remote
support groups to be conducted via the internet, "e-Support." Attending a remote, internet
based support group may be more appealing to patients with MS as it obviates the need to
travel, thereby reducing cost, time, and energy.
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