An interventional study of e-Support group and e-Journaling placebo in Multiple Sclerosis, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-01.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
Primary objectives:
Secondary objective:
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will receive the treatment, 12 weeks of 1-hr weekly moderated e-Support sessions.
Behavioral: e-Support group
Participants in this arm will complete 12 weeks of 1-hr weekly online journaling activities.
Behavioral: e-Journaling placebo
Online (remote), web-based support group via private video link.
Also known as: e-Support
Online journaling activity.
Also known as: e-Journaling
Percentage of enrolled participants who completed follow-up questionnaires
Assess feasibility of the program: to retain and obtain completed questionnaires at immediate follow-up from 80% of enrolled participants (meeting the criteria of 75% attendance).
Time frame: 12 weeks
Change in UCLA Loneliness Scale total score (please note that the official name of the scale is the UCLA Loneliness Scale).
Assess efficacy of the program to decrease loneliness as defined by a significant decrease in total score on UCLA Loneliness Scale. This name never appears as anything other than UCLA Loneliness Scale, i.e. Russell 1996)
Time frame: Baseline, 12 weeks (immediate follow-up)
Change in overall depression [Patient Health Questionnaire (PHQ-9)] total score
Assess efficacy of the program to decrease depression as defined by a significant decrease in total score on Patient Health Questionnaire (PHQ-9): an efficient tool for depression screening. The scale ranges from 0-27, with higher scores indicating worse depression.
Time frame: Baseline, 12 weeks
Change in overall Functional Assessment of Multiple Sclerosis Quality of Life (FAMS QoL) score
Assess efficacy of the program to improve quality of life. The Functional Assessment of Multiple Sclerosis (FAMS) quality of life (QoL) instrument is a disease-specific, self-report questionnaire. It includes 7 subscales. The total score is generated by summing scores across all subscales, and ranges from 0-232, with higher scores reflective or worse overall function. In addition to considering a significant decrease in the total score as an indication of better overall function, we will separately examine each subscale to see whether decreases in score (indicating improvements in function) are shown. This includes the following subscales: mobility, symptoms, emotional well-being, general contentment, thinking and fatigue, family/social well-being, and additional concerns scales.
Time frame: Baseline, 12 weeks
Plan to share: Undecided
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Columbia University