Clinical trial NCT05195320: Reinventing Yourself With Multiple Sclerosis (MS)
Official title: Reinventing Yourself With Multiple Sclerosis (MS): An Intervention Aimed at Improving Self-Efficacy, Coping, Psychological Well-being, and Quality of Life in MS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Craig Hospital
name: University of Minnesota
First posted: 2022-01-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Multiple Sclerosis Self-Efficacy Scale
timeFrame: Through study completion, an average of 6 months
measure: General Self-Efficacy Scale
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Health Status Questionnaire
timeFrame: Through study completion, an average of 6 months
measure: Satisfaction with Life Scale
timeFrame: Through study completion, an average of 6 months
measure: Ryff Psychological Well-being Scales
timeFrame: Through study completion, an average of 6 months
measure: Participation Assessment with Recombined Tools-Objective (PART-O)
timeFrame: Through study completion, an average of 6 months
measure: Chicago Multiscale Depression Inventory
timeFrame: Through study completion, an average of 6 months
measure: State Trait Anxiety Scale
timeFrame: Through study completion, an average of 6 months
measure: Connor-Davidson Resilience Scale
timeFrame: Through study completion, an average of 6 months
measure: Benefit Finding in Multiple Sclerosis Scale
timeFrame: Through study completion, an average of 6 months
measure: Cope Inventory
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: