NCT04379661

Brief Summary

Stress and anxiety can have an adverse impact on health, and the experience of many around the 2020 outbreak of COVID-19 is affecting health and well-being. Individuals with chronic disease such as multiple sclerosis may be particularly vulnerable in some ways, but also particularly resilient in others. This study evaluates the effects of belonging to online support groups that meet weekly for 12 weeks to address the stress and anxiety felt by individuals with Multiple Sclerosis (MS). This study will also measure and explore the effects of online support groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

May 5, 2020

Last Update Submit

January 7, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Rate of completion

    Acceptable rate is defined as at least 66% of participants who complete follow-up surveys.

    Up to 12 weeks

  • Rate of adherence

    Acceptable rate is defined as at least 66% of sessions being attended.

    Up to 12 weeks

Secondary Outcomes (1)

  • Score on the State Trait Anxiety Inventory (STAI)

    Up to 12 weeks

Other Outcomes (1)

  • Score on the Personal Health Questionnaire Depression Scale (PHQ-8)

    Up to 12 weeks

Study Arms (2)

Online support group

EXPERIMENTAL

Online weekly 1-hour moderated support group sessions for 12-weeks; participants complete surveys at baseline and 12-week follow-up

Behavioral: Online support Group

Treatment as usual

NO INTERVENTION

Inactive control group of participants who complete surveys at baseline and 12-weeks later

Interventions

12 one-hour, once-weekly online support groups for people with Multiple Sclerosis to address anxiety related to the COVID-19 outbreak and its effects on them.

Online support group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MS Diagnosis
  • years or older

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Multiple SclerosisCOVID-19

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Victoria Leavitt, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neuropsychology

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 7, 2020

Study Start

May 7, 2020

Primary Completion

July 7, 2020

Study Completion

August 31, 2020

Last Updated

January 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations