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The SEMS Project: Staying Employed With MS

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ClinicalTrials.gov Identifier: NCT03647904
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Lauren Strober, Kessler Foundation

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: SEMS Project Not Applicable

Detailed Description:

Multiple sclerosis (MS), a disorder of young and middle aged adults, has a grave impact on one's well-being and incurs a significant cost to society due to the nearly 80% rate of unemployment.1,2 Over the past few decades, research has focused on increasing our understanding of the factors that lead to the high unemployment rates in MS and ways to mitigate such factors. However, the majority of investigations examining the determinants of unemployment in MS have been retrospective and limited in their focus to factors such as demographics, disease symptoms and severity, 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 contribute to unemployment rates in MS. In fact, one of the earliest investigations examining the "common" factors associated with unemployment in MS asserted that premorbid personality, education level, quality of environment, and social/family network were likely to affect how an individual with MS reacted to their illness, including attitudes towards employment.2 By applying a new conceptual model that incorporates such person-specific factors, and controls for the more typical demographic and disease variable predictors of unemployment in persons with MS, these investigators have shown that personality characteristics, anxiety, depression, coping, and self-efficacy differ between individuals who are considering leaving the workforce and those who stay employed. Perhaps most striking, was the finding that these individuals had an average disease duration of only 6.7 years compared to 10.4 years of those staying employed. Moreover, 62% were within 5 years of diagnosis compared to only 36% among those staying employed. This nearly double rate may reflect poor adjustment to illness rather than a result of greater disability per se. Based on these findings, these investigators postulate that individuals who are considering leaving the workforce or reducing work hours could benefit from early intervention targeting person-specific vulnerability factors. Such intervention should not only address the cognitive, psychological, and physical consequences of MS, but also attend to vital premorbid and psychological factors (e.g., anxiety, coping, self-efficacy), which in some ways may better account for why individuals leave the workforce. Moreover, given the negative psychological and health consequences of unemployment, in general, it is imperative that we assist such individuals in maintaining their employment and adjustment to MS to ward of further reductions in overall well-being and quality of life. Thus, the proposed investigation aims to assist individuals with MS maintain their employment by developing a comprehensive intervention that will target both the disease and person-specific factors associated with unemployment in MS; 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 it may consist of any or all relevant components of cognitive rehabilitation, fatigue and symptom management, wellness intervention, and psychological intervention. Outcomes will be assessed following such intervention, with the goal of enhancing greater commitment to work and job maintenance that will ensure continuity of purpose and satisfaction in life, health and health maintenance, and overall well-being. We will also assess change and process variables throughout the intervention to gain a better sense of the factors that facilitate change across these interventions. In sum, the specific aims of the proposed investigation are to:

Specific Aim 1: Develop and pilot a comprehensive and personally responsive (modular) intervention to assist individuals with MS remain in the workplace and examine the factors most associated with such change.

Specific Aim 2: Examine the immediate and long-term (3 month) outcomes of this intervention on functioning, well-being, self-efficacy, disease management, health, and overall quality of life.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Wait list control
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor will not know if individual were in the treatment group or waitlist control group
Primary Purpose: Treatment
Official Title: The SEMS Project: Staying Employed With MS
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SEMS Project
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
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.

Wait List Control
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
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.




Primary Outcome Measures :
  1. Change in Work Commitment [ Time Frame: baseline, immediate post-intervention, 3 month post-intervention ]
    One's ability to maintain their current work status and function as measured by the employment outcome questionnaire

  2. Change in adjustment to MS [ Time Frame: baseline, immediate post-intervention, 3 month post-intervention ]
    Self-reported perception of coping skills as measured by the COPE questionnaire

  3. Change in self-efficacy [ Time Frame: baseline, immediate post-intervention, 3 month post-intervention ]
    Self-reported self-efficacy as measured by the General Self-efficacy Questionnaire


Secondary Outcome Measures :
  1. Change in mood [ Time Frame: baseline, immediate post-intervention, 3 month post-intervention ]
    Self reported depression as measured by the Chicago Multiscale Depression Inventory questionnaire

  2. Change in anxiety [ Time Frame: baseline, immediate post-intervention, 3 month post-intervention ]
    Self-reported anxiety as measured by the State Trait Anxiety Inventory questionnaire

  3. Change in psychological well-being [ Time Frame: baseline, immediate post-intervention, 3 month post-intervention ]
    Self-reported psychological well-being as measured by the Ryff Psychological well-being scales

  4. Changes in stress [ Time Frame: baseline, immediate post-intervention, 3 month post-intervention ]
    Self-reported stress as measured by the Perceived Stress Scale questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with MS based on McDonald Criteria

Exclusion Criteria:

  • any neurological condition other than MS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647904


Contacts
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Contact: Lauren Strober 973-324-8459 lstrober@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Lauren Strober, PhD    973-324-8459    lstrober@kesslerfoundation.org   
Principal Investigator: Lauren Strober, PhD         
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Lauren Strober Kessler Foundation

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Responsible Party: Lauren Strober, Senior Research Scientist, Kessler Foundation
ClinicalTrials.gov Identifier: NCT03647904     History of Changes
Other Study ID Numbers: E-944-16
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lauren Strober, Kessler Foundation:
Employment
Self efficacy
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases