E-Support Groups in Multiple Sclerosis

NCT03574961 | Completed

• 1 other identifier: AAAR4052
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objectives:

• To determine the feasibility of program (80% retained with 75% overall attendance, and completed immediate follow-up questionnaires from 75% of participants).
• To determine the efficacy of program (evaluated by decreased loneliness, operationalized as decreased total score on the UCLA Loneliness Scale from pre to post intervention). Secondary objective:
• To determine whether program will affect depression and quality of life.

Conditions

Multiple Sclerosis

Keywords

depression; social isolation

Outcome Measures

Primary Outcomes (2)

• Percentage of enrolled participants who completed follow-up questionnaires

  Assess feasibility of the program: to retain and obtain completed questionnaires at immediate follow-up from 80% of enrolled participants (meeting the criteria of 75% attendance).

  12 weeks

• Change in UCLA Loneliness Scale total score (please note that the official name of the scale is the UCLA Loneliness Scale).

  Assess efficacy of the program to decrease loneliness as defined by a significant decrease in total score on UCLA Loneliness Scale. This name never appears as anything other than UCLA Loneliness Scale, i.e. Russell 1996)

  Baseline, 12 weeks (immediate follow-up)

Secondary Outcomes (2)

• Change in overall depression [Patient Health Questionnaire (PHQ-9)] total score

  Baseline, 12 weeks

• Change in overall Functional Assessment of Multiple Sclerosis Quality of Life (FAMS QoL) score

  Baseline, 12 weeks

Study Arms (2)

e-Support Group

EXPERIMENTAL

Participants in this arm will receive the treatment, 12 weeks of 1-hr weekly moderated e-Support sessions.

Behavioral: e-Support group

e-Journaling Placebo

PLACEBO COMPARATOR

Participants in this arm will complete 12 weeks of 1-hr weekly online journaling activities.

Behavioral: e-Journaling placebo

Interventions

e-Support group BEHAVIORAL

Online (remote), web-based support group via private video link.

Also known as: e-Support

e-Support Group

e-Journaling placebo BEHAVIORAL

Online journaling activity.

Also known as: e-Journaling

e-Journaling Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of MS (any disease type)
• Age 18 or over
• Willingness to sign informed consent document

You may not qualify if:

• Unable to obtain access to the internet

Sponsors & Collaborators

• Columbia University: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Columbia University Medical Center (MS Center)

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Depression; Social Isolation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Victoria M Leavitt, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neuropsychology (in Neurology and Gertrud, Dept of Neur Neuropsychology

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 2, 2018
• Study Start: May 10, 2018
• Primary Completion: April 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

US (1)