E-Support Groups in Multiple Sclerosis (eSupport)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-Support group
e-Journaling placebo
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring depression, social isolation
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of MS (any disease type)
- Age 18 or over
- Willingness to sign informed consent document
Exclusion Criteria:
- Unable to obtain access to the internet
Sites / Locations
- Columbia University Medical Center (MS Center)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
e-Support Group
e-Journaling Placebo
Arm Description
Participants in this arm will receive the treatment, 12 weeks of 1-hr weekly moderated e-Support sessions.
Participants in this arm will complete 12 weeks of 1-hr weekly online journaling activities.
Outcomes
Primary Outcome Measures
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).
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)
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03574961
First Posted
June 21, 2018
Last Updated
August 29, 2020
Sponsor
Columbia University
Collaborators
National Multiple Sclerosis Society
1. Study Identification
Unique Protocol Identification Number
NCT03574961
Brief Title
E-Support Groups in Multiple Sclerosis
Acronym
eSupport
Official Title
A Randomized Controlled Trial of e-Support in Persons With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Multiple Sclerosis Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
depression, social isolation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
e-Support Group
Arm Type
Experimental
Arm Description
Participants in this arm will receive the treatment, 12 weeks of 1-hr weekly moderated e-Support sessions.
Arm Title
e-Journaling Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will complete 12 weeks of 1-hr weekly online journaling activities.
Intervention Type
Behavioral
Intervention Name(s)
e-Support group
Other Intervention Name(s)
e-Support
Intervention Description
Online (remote), web-based support group via private video link.
Intervention Type
Behavioral
Intervention Name(s)
e-Journaling placebo
Other Intervention Name(s)
e-Journaling
Intervention Description
Online journaling activity.
Primary Outcome Measure Information:
Title
Percentage of enrolled participants who completed follow-up questionnaires
Description
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
Title
Change in UCLA Loneliness Scale total score (please note that the official name of the scale is the UCLA Loneliness Scale).
Description
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)
Secondary Outcome Measure Information:
Title
Change in overall depression [Patient Health Questionnaire (PHQ-9)] total score
Description
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
Title
Change in overall Functional Assessment of Multiple Sclerosis Quality of Life (FAMS QoL) score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of MS (any disease type)
Age 18 or over
Willingness to sign informed consent document
Exclusion Criteria:
Unable to obtain access to the internet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria M Leavitt, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center (MS Center)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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E-Support Groups in Multiple Sclerosis
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