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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PwMS eSupport Groups | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eSupport Health Weekly Group Sessions for PwMS | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment in MS (FAMS) | A tertiary objective is to determine efficacy: whether participation in 12-weeks of eSupport Health online groups results in improved quality of life. | through study completion, up to 40 weeks |
| UCLA Loneliness Scale Version 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria M Leavitt, Leavitt | eSupport Health, PBC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| eSupport Health | New York | New York | 10018 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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].
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A tertiary objective is to determine efficacy: whether participation in 12-weeks of eSupport Health online groups results in decreased loneliness. |
| through study completion, up to 40 weeks |
| Treatment adherence / healthcare utilization | A tertiary objective is to evaluate change in treatment adherence / healthcare utilization. | through study completion, up to 40 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |