Columbia University Medical Center (MS Center)
New York, 10032, United States
NCT Number: NCT03574961
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10032, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Online (remote), web-based support group via private video link.
Other names: e-Support
Online journaling activity.
Other names: e-Journaling
Time frame: 12 weeks
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: Baseline, 12 weeks (immediate follow-up)
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
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
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.
Columbia University
Other
A Randomized Controlled Trial of e-Support in Persons With Multiple Sclerosis
Acronym: eSupport
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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