CONNECT Trial of eSupport Online Health-coach Moderated Support Groups for Multiple Sclerosis

Study Overview
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Brief Summary
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Within-subject waitlist-control group design trial of eSupport health-coach moderated online support group participation to address mental health needs in persons with multiple sclerosis (PwMS) from historically underrepresented groups (i.e., Black and Latinx patients).

Detailed Description
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The purpose of this research is to see how well a new online eSupport Health Weekly Group Sessions program addresses the needs and improves the mood of adults with MS. This study is focusing on improving the online eSupport Weekly Group Session program for people with MS while assessing the impact of the program, particularly for Black and Latinx individuals as clinical research has often not included their experience. The entire study is done remotely by computer, tablet, or smartphone with a web camera and with a stable internet connection. Subjects will be enrolled into closed, private, health-coach facilitated online support groups called eSupport Health Weekly Group Sessions. These sessions are hosted on eSupport Health's proprietary Zoom-based secure HIPAA-compliant telehealth platform. Each group is expected to have 10 participants and will meet weekly for 12 weeks. A licensed therapist (Study Coach) leads the group sessions. The company's Mutual Respect & Trust (MRT)-based coaching method is utilized.

Official Title
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Clinical Trial of a Telehealth Group-Based Intervention to Improve Mood in Underrepresented Individuals With Multiple Sclerosis: The Connect Trial (CONNECT)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: eSupport Health Weekly Group Sessions for PwMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form (ICF) Able to speak, read and understand English Reside in the U.S. Willingness to enroll as a member in eSupport Health Stated willingness to comply with all study procedures and availability for the duration of the study Willingness to adhere to the schedule of weekly online meetings with a minimum of 50% attendance (i.e., 6 of 12 meetings) Males and females; Age 18+ Self-reported diagnosis of multiple sclerosis including the date of the diagnosis (month and year) and the name of the diagnosing physician Access to necessary resources for participating in a technology-based intervention (i.e., computer or tablet with a web camera and with a stable internet connection in a private setting) and demonstrated basic ability to use a computer by completing the electronic ICF completion process and meeting with the Study Coach via Zoom Telehealth secured platform at the Enrollment Session. Provide identification to verify name, date of birth, and address. Exclusion Criteria: Current participation in another treatment or intervention study Presence of a condition(s) or diagnosis, either physical or psychological that precludes participation such as significant brain injury and developmental disability Current suicidal intent Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Each participant will serve as his/her own control; after a 12-week waitlist control period, each participant will complete a 12-week treatment period [note that the very first group of enrolled participants (N  10) will not have a waitlist period, but will instead enter directly into the 12-week treatment period].
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PwMS eSupport Groups<br>12-weeks active treatment of eSupport Health's Weekly Group Sessions, a formal semi-structured program of psychoeducational support delivered in a small group format by licensed therapists who specialize in MS. The active treatment period will follow a 12-week waitlist period that will be used to enable a within-subject control design. Note that the very first group enrolled (N 10) will not have a 12-week waitlist period but will instead enter directly into the 12-week treatment. | Behavioral: eSupport Health Weekly Group Sessions for PwMS<br>* A formal semi-structured program of psychoeducational support delivered in an online weekly small group format by health coaches (licensed therapists) who specialize in MS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence and completion | The primary objective is to establish feasibility, defined as acceptable rates of <1> adherence, and <2> completion. | through study completion, 20-40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | The primary efficacy outcome is to determine whether participation in 12-weeks of eSupport Health online groups results in decreased anxiety or depression. | through study completion, up to 40 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Online Support Group