E-Support Groups in Multiple Sclerosis

Study Overview
=================
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.

Official Title
-----------------
A Randomized Controlled Trial of e-Support in Persons With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Behavioral: e-Support group
* Behavioral: e-Journaling placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e-Support Group<br>Participants in this arm will receive the treatment, 12 weeks of 1-hr weekly moderated e-Support sessions. | Behavioral: e-Support group<br>* Online (remote), web-based support group via private video link.<br>* Other names: e-Support;|
| Placebo Comparator: e-Journaling Placebo<br>Participants in this arm will complete 12 weeks of 1-hr weekly online journaling activities. | Behavioral: e-Journaling placebo<br>* Online journaling activity.<br>* Other names: e-Journaling;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 weeks | 
| 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) | Baseline, 12 weeks (immediate follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 12 weeks | 
| 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. | Baseline, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, social isolation