Reinventing Yourself With Multiple Sclerosis (MS)

NCT ID: NCT05195320

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-09-30

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.

Detailed Description

Multiple sclerosis (MS) is the leading cause of disability among middle-aged adults with recent estimates of nearly 1 million adults living with MS in the United States. Multiple sclerosis affects women anywhere from two to three times as often as men, with an age of diagnosis ranging from 20 to 50 years of age and a mean age of onset of 33 years of age. A host of physical, cognitive, and behavioral changes are common following the onset of this most common non-traumatic neurological disorder of middle adulthood, which greatly impacts quality of life (QOL), well-being, and everyday functioning and participation. Moreover, given that individuals are typically diagnosed with MS in the prime of their lives many are making important life decisions regarding work, family, etc. that are often hindered by their diagnosis. In fact, it has been found that men and women with MS aged 25-44, an age at which important early life decisions are often made, experienced more depression than their age-matched, healthy counterparts. Again, the course of the disease is variable and unpredictable with no known cure, which can lead to great uncertainty and difficulty in adjusting to a chronic and often, debilitating disease.

The overarching aim of the proposed investigation is to adapt the Reinventing Yourself intervention for use with MS and examine the feasibility and efficacy in increasing MS-specific and general self-efficacy and resilience, enhancing psychological well-being, fostering new ways of perceiving and managing one's illness in more proactive and positive ways, and improving participation in the community. To achieve this, the investigation has the following specific aims:

Specific Aim 1: Conduct a focus group with individuals with MS to identify unique needs of individuals with MS with regard to MS symptoms, barriers to well-being, QOL, and participation, and the role that person-specific factors (e.g., self-efficacy, resilience) and other psychological and social factors have contributed to success (or failure) in managing one's illness and living well.

Specific Aim 2: With the knowledge gained from Aim 1, modify the Reinventing Yourself intervention with the specific needs of MS, while maintaining the integrity and common principles of the Reinventing Yourself intervention.

Specific Aim 3: Conduct a RCT among individuals with MS to determine the feasibility and efficacy of the Reinventing Yourself with MS intervention.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group Intervention

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.

Group Type: EXPERIMENTAL

Reinvention with MS

Intervention Type: BEHAVIORAL

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Reinvention with MS

Intervention Type: BEHAVIORAL

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

Interventions

Reinvention with MS

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of multiple sclerosis
• 18 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).

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Craig Hospital

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kessler Foundation

East Hanover, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren Strober, PhD

Role: CONTACT

lstrober@kesslerfoundation.org

973-324-8459

Amanda L Botticello, PhD

Role: CONTACT

abotticello@kesslerfoundation.org

973-243-6973

Facility Contacts

Rachel Byrne, MA

Role: primary

rbyrne@kesslerfoundation.org

973-324-3567

Lauren Strober, PhD

Role: backup

lstrober@kesslerfoundation.org

973.324.8459

Other Identifiers

R-1164-21

Identifier Type: -

Identifier Source: org_study_id