The SEMS Project: Staying Employed With MS

NCT03647904 | Unknown

• 1 other identifier: E-944-16
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Description of Project: Multiple sclerosis (MS), a disorder of young and middle aged adults, is known to have a grave impact on one's well-being and incurs a significant cost to society due to the nearly 80% rate of unemployment. Over the past few decades, research has focused on increasing our understanding of the factors that lead to these high rates of unemployment in MS and ways to mitigate such factors. However, the majority of investigations examining the causes of unemployment in MS have been retrospective and limited their focus to factors such as demographics, disease severity and symptoms of MS (e.g., fatigue), and/ or work place features and accommodations. Few have examined the more intrinsic, or person-specific factors (e.g., personality, coping, health-related behaviors), which are also likely to significantly contribute to rates of unemployment in MS. In fact, these investigators have shown that personality characteristics, anxiety, depression, coping, and self-efficacy differ between individuals who are considering leaving the workforce and those staying employed; even in the presence of comparable demographics and disease variables. Based on these findings, and the knowledge that fatigue and cognition also greatly contribute to this decision, these investigators have proposed a comprehensive intervention that will target both the disease and person-specific factors in hope of assisting individuals with MS maintain their employment; the ultimate goal being to improve the overall quality of life and health of individuals with MS. The proposed modular intervention will be tailored to the individual based on a preliminary assessment and consist of cognitive rehabilitation, fatigue and symptom management, wellness intervention, psychological intervention, and occupational rehabilitation. Outcomes will be assessed following such intervention with the goal being either job maintenance or comparable life activities that will ensure continuity of purpose and satisfaction in life, health and health maintenance, and overall well-being.

Conditions

Multiple Sclerosis

Keywords

Employment; Self efficacy

Outcome Measures

Primary Outcomes (3)

• Change in Work Commitment

  One's ability to maintain their current work status and function as measured by the employment outcome questionnaire

  baseline, immediate post-intervention, 3 month post-intervention

• Change in adjustment to MS

  Self-reported perception of coping skills as measured by the COPE questionnaire

  baseline, immediate post-intervention, 3 month post-intervention

• Change in self-efficacy

  Self-reported self-efficacy as measured by the General Self-efficacy Questionnaire

  baseline, immediate post-intervention, 3 month post-intervention

Secondary Outcomes (4)

• Change in mood

  baseline, immediate post-intervention, 3 month post-intervention

• Change in anxiety

  baseline, immediate post-intervention, 3 month post-intervention

• Change in psychological well-being

  baseline, immediate post-intervention, 3 month post-intervention

• Changes in stress

  baseline, immediate post-intervention, 3 month post-intervention

Study Arms (2)

SEMS Project

EXPERIMENTAL

A comprehensive modular intervention consisting of wellness, fatigue management, cognitive remediation and psychological treatment. Treatment will consist of a total of 12 weeks.

Behavioral: SEMS Project

Wait List Control

OTHER

Individuals in the wait list control arm will serve as controls for the first intervention group, but will receive the treatment following their three month assessment. The intervention following the waitlist control will be a comprehensive modular intervention consisting of wellness, fatigue management, cognitive remediation and psychological treatment. Treatment will consist of a total of 12 weeks.

Behavioral: SEMS Project

Interventions

SEMS Project BEHAVIORAL

TThe intervention is a culmination of five empirically supported interventions: (1) The MS Wellness Program aimed at developing lifestyle strategies to enhance quality of living and cope with various aspects of MS; (2) The FACETS intervention, which aims to reduce fatigue and improve self-efficacy; (3) The Modified Story Memory technique, which improves new learning and memory; (4) The Speed of Processing training, which improves performance on measures of processing speed in persons with MS. Finally, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, a cognitive behavioral intervention, which improves psychological functioning and functional outcomes.

SEMS Project; Wait List Control

Eligibility Criteria

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

You may qualify if:

• diagnosed with MS based on McDonald Criteria

You may not qualify if:

• any neurological condition other than MS

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, 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

Study Officials

• Lauren Strober

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Strober

CONTACT

973-324-8459; lstrober@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will not know if individual were in the treatment group or waitlist control group
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: Wait list control

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: August 27, 2018
• Study Start: October 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)