Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-03 @ 8:45 PM
Study NCT ID:
NCT03574961
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2018-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E-Support Groups in Multiple Sclerosis
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial of e-Support in Persons With Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eSupport
Brief Summary:
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.
* 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: