Clinical trial NCT04943887: CONNECT Trial of eSupport Online Health-coach Moderated Support Groups for Multiple Sclerosis
Official title: Clinical Trial of a Telehealth Group-Based Intervention to Improve Mood in Underrepresented Individuals With Multiple Sclerosis: The Connect Trial (CONNECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Online Support Group
Lead sponsor: eSupport Health
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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 \[note that the very first group of enrolled participants (N \~10) will not have a waitlist period, but will instead enter directly into the 12-week treatment period\].
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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:

1. Current participation in another treatment or intervention study
2. Presence of a condition(s) or diagnosis, either physical or psychological that precludes participation such as significant brain injury and developmental disability
3. Current suicidal intent
4. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Primary outcomes:
measure: Adherence and completion
timeFrame: through study completion, 20-40 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: through study completion, up to 40 weeks
Other outcomes:
measure: Functional Assessment in MS (FAMS)
timeFrame: through study completion, up to 40 weeks
measure: UCLA Loneliness Scale Version 3
timeFrame: through study completion, up to 40 weeks
measure: Treatment adherence / healthcare utilization
timeFrame: through study completion, up to 40 weeks
Locations:
city: New York
country: United States
facility: eSupport Health
state: New York
Study officials:
affiliation: eSupport Health, PBC
name: Victoria M Leavitt, Leavitt
role: PRINCIPAL_INVESTIGATOR
References: