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E-Support Groups in Multiple Sclerosis (eSupport)

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ClinicalTrials.gov Identifier: NCT03574961
Recruitment Status : Active, not recruiting
First Posted : July 2, 2018
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Victoria M. Leavitt, Columbia University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: e-Support group Behavioral: e-Journaling placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of e-Support in Persons With Multiple Sclerosis
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: e-Support Group
Participants in this arm will receive the treatment, 12 weeks of 1-hr weekly moderated e-Support sessions.
Behavioral: e-Support group
Online (remote), web-based support group via private video link.
Other Name: e-Support

Placebo Comparator: e-Journaling Placebo
Participants in this arm will complete 12 weeks of 1-hr weekly online journaling activities.
Behavioral: e-Journaling placebo
Online journaling activity.
Other Name: e-Journaling




Primary Outcome Measures :
  1. Percentage of enrolled participants who completed follow-up questionnaires [ 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).

  2. Change in UCLA Loneliness Scale total score (please note that the official name of the scale is the UCLA Loneliness Scale). [ 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)


Secondary Outcome Measures :
  1. Change in overall depression [Patient Health Questionnaire (PHQ-9)] total score [ 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.

  2. Change in overall Functional Assessment of Multiple Sclerosis Quality of Life (FAMS QoL) score [ 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574961


Locations
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United States, New York
Columbia University Medical Center (MS Center)
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Victoria M Leavitt, PhD Columbia University

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Responsible Party: Victoria M. Leavitt, Assistant Professor of Neuropsychology (in Neurology and Gertrud, Dept of Neur Neuropsychology, Columbia University
ClinicalTrials.gov Identifier: NCT03574961     History of Changes
Other Study ID Numbers: AAAR4052
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Victoria M. Leavitt, Columbia University:
depression
social isolation
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases