Reinventing Yourself With Multiple Sclerosis (MS)

NCT05195320 | Unknown

• 1 other identifier: R-1164-21
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Given the knowledge that detriments in QOL, well-being, and participation are common in MS and attributable in a large part to individual, person-specific factors (e.g., self-efficacy), efforts to develop interventions aimed at addressing these factors is well needed and likely to have a significant impact. The proposed investigation will consist of two phases involving participant recruitment and data collection. Phase 1 will consist of a focus group aimed at identifying the unique needs of individuals with MS, and findings will be used to adapt the Reinventing Yourself after Spinal Cord Injury (SCI) intervention to Reinventing Yourself with MS. Phase 2 will consist of a randomized controlled trial (RCT) in which the feasibility and efficacy of the intervention in a new population can be examined.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Multiple Sclerosis Self-Efficacy Scale

  This scale measures self-efficacy related to the experience of MS symptoms and sequelae. Scores range from 14-84. Higher scores indicate greater self-efficacy.

  Through study completion, an average of 6 months

• General Self-Efficacy Scale

  This scale measures one's general ability to control their behaviors and execute goals. Scores range from 10-44. Higher scores indicate greater self-efficacy

  Through study completion, an average of 6 months

Secondary Outcomes (9)

• Health Status Questionnaire

  Through study completion, an average of 6 months

• Satisfaction with Life Scale

  Through study completion, an average of 6 months

• Ryff Psychological Well-being Scales

  Through study completion, an average of 6 months

• Participation Assessment with Recombined Tools-Objective (PART-O)

  Through study completion, an average of 6 months

• Chicago Multiscale Depression Inventory

  Through study completion, an average of 6 months

Study Arms (2)

Group Intervention

EXPERIMENTAL

Participants will attend six weekly two-hour facilitator-led sessions that include didactic presentations of eight core skills and related experiential exercises with extensive group discussion. These skills are presented in sequence over the course of the intervention so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex. The culmination of developing these skills and participation in a peer group will assist individuals in increasing self-efficacy and overall QOL, well-being and participation. Participants will complete follow-up assessment at 18- and 30-weeks post-intervention.

Behavioral: Reinvention with MS

Placebo

PLACEBO COMPARATOR

Participants will receive no intervention throughout the course of the study; however, the participants will be tested at 18- and 30-weeks participation in the study.

Behavioral: Reinvention with MS

Interventions

Reinvention with MS BEHAVIORAL

A manualized group therapy to build self-efficacy among people living with multiple sclerosis.

Group Intervention; 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 multiple sclerosis
• years of age or older
• English-speaking
• Able to provide informed consent
• Access to the internet (if needed should the groups have to be conducted online due to pandemic circumstances that may limit to in-person meetings).

You may not qualify if:

• History of any other neurological illness (e.g. traumatic brain injury, epilepsy, dementia)
• Cognitive impairment that would affect my ability to fully participate in the group
• (For in-person group): Live beyond a reasonable commuting distance (50+ miles)
• Any other medical or psychological condition that, in the judgement of the investigators, prevents successful participation in the study

Sponsors & Collaborators

• Kessler Foundation: lead
• Craig Hospital: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07036, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Lauren Strober, PhD

CONTACT

973-324-8459; lstrober@kesslerfoundation.org

Amanda L Botticello, PhD

CONTACT

973-243-6973; abotticello@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Staff administering assessments will be blinded to group assignment (Intervention or control). Participants and group facilitators will be carefully instructed not to reveal group assignment to assessment administrators. Following each assessment, the blinded data collector will note whether unblinding occurred; this information will be entered into the study's web database. As an additional protection, blinded data collectors will have restricted access to the study database as some of the information that is collected would reveal group assignment (e.g., attendance of group members at sessions); this information will be entered into the database by unblinded staff. To track potential unblinding, blinded data collectors will respond to a two-item assessment of unblinding following each outcome assessment administered.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A sample of 48 participants randomly assigned to either the intervention or control group (Intervention, N=24 and Controls, N=24) over four cohorts. Participants in each cohort will be randomized to either the intervention or control group with equal probability so that each group has 6 participants. That is, once 12 subjects have been recruited, they will form a cohort, be randomized into one of the two groups, and begin the study intervention; this process will continue until 48 subjects have been recruited into four cohorts.

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: January 18, 2022
• Study Start: August 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)