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Multiple SclerosisNCT03647904

The SEMS Project: Staying Employed With MS

A study testing SEMS Project in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
SEMS Project
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
1 Oct 2017to Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosed with MS based on McDonald Criteria

Who cannot join

  • any neurological condition other than MS

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Kessler Foundation

    East Hanover, New Jersey, 07936

    Lauren Strober, PhD, 973-324-8459, lstrober@kesslerfoundation.org

    Lauren Strober, PhD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
SEMS Project
Keywords
Employment, Self efficacy
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEMS ProjectBehavioural

    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.

Study groups in NCT03647904
Study groupRoleWhat they receive
SEMS ProjectExperimentalA comprehensive modular intervention consisting of wellness, fatigue management, cognitive remediation and psychological treatment. Treatment will consist of a total of 12 weeks.
Receives: Behavioral: SEMS Project
Wait List ControlOtherIndividuals 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.
Receives: Behavioral: SEMS Project

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Work Commitment

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

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

  2. Change in adjustment to MS

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

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

  3. Change in self-efficacy

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

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

Secondary outcomes (4)
  1. Change in mood

    Self reported depression as measured by the Chicago Multiscale Depression Inventory questionnaire

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

  2. Change in anxiety

    Self-reported anxiety as measured by the State Trait Anxiety Inventory questionnaire

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

  3. Change in psychological well-being

    Self-reported psychological well-being as measured by the Ryff Psychological well-being scales

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

  4. Changes in stress

    Self-reported stress as measured by the Perceived Stress Scale questionnaire

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2018
  2. Study start1 Oct 2017
  3. Primary completionOct 2018 (estimated)
  4. Study completionOct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Wait list control
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03647904
Sponsor's protocol ID
E-944-16
Status last verified
Aug 2018
First submitted
25 Jan 2018
Last updated
27 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SEMS Project in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lauren Strober (973-324-8459, lstrober@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Work Commitment (time frame: baseline, immediate post-intervention, 3 month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.

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The SEMS Project: Staying Employed With MS | AzTrials