Clinical trial NCT03574961: E-Support Groups in Multiple Sclerosis
Official title: A Randomized Controlled Trial of e-Support in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: depression
social isolation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2018-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of enrolled participants who completed follow-up questionnaires
timeFrame: 12 weeks
measure: Change in UCLA Loneliness Scale total score (please note that the official name of the scale is the UCLA Loneliness Scale).
timeFrame: Baseline, 12 weeks (immediate follow-up)
Secondary outcomes:
measure: Change in overall depression [Patient Health Questionnaire (PHQ-9)] total score
timeFrame: Baseline, 12 weeks
measure: Change in overall Functional Assessment of Multiple Sclerosis Quality of Life (FAMS QoL) score
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center (MS Center)
state: New York
Study officials:
affiliation: Columbia University
name: Victoria M Leavitt, PhD
role: PRINCIPAL_INVESTIGATOR
References: