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OpenTrials
Completed

NCT Number: NCT04943887

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

eSupport Health

New York, 10018, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Adherence and completion

    Time frame: through study completion, 20-40 weeks

    The primary objective is to establish feasibility, defined as acceptable rates of <1> adherence, and <2> completion.

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: through study completion, up to 40 weeks

    The primary efficacy outcome is to determine whether participation in 12-weeks of eSupport Health online groups results in decreased anxiety or depression.

Other outcomes

  1. Functional Assessment in MS (FAMS)

    Time frame: through study completion, up to 40 weeks

    A tertiary objective is to determine efficacy: whether participation in 12-weeks of eSupport Health online groups results in improved quality of life.

  2. UCLA Loneliness Scale Version 3

    Time frame: through study completion, up to 40 weeks

    A tertiary objective is to determine efficacy: whether participation in 12-weeks of eSupport Health online groups results in decreased loneliness.

  3. Treatment adherence / healthcare utilization

    Time frame: through study completion, up to 40 weeks

    A tertiary objective is to evaluate change in treatment adherence / healthcare utilization.

Sponsors and collaborators

Lead sponsor

eSupport Health

Other

Registry information

Official study title

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

Acronym: CONNECT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2021
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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