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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Lauren Strober, PhD, 973-324-8459, lstrober@kesslerfoundation.org
Lauren Strober, PhD
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.
- Conditions
- Multiple Sclerosis
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: SEMS Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
Change in mood
Self reported depression as measured by the Chicago Multiscale Depression Inventory questionnaire
Measured: baseline, immediate post-intervention, 3 month post-intervention
Change in anxiety
Self-reported anxiety as measured by the State Trait Anxiety Inventory questionnaire
Measured: baseline, immediate post-intervention, 3 month post-intervention
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
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.
- First posted27 Aug 2018
- Study start1 Oct 2017
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Strober, Kessler Foundation
- Investigators
- Lauren Strober, Principal investigator, Kessler Foundation
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SEMS Project: Staying Employed With MS
- ClinicalTrials.gov ID
- NCT03647904
- Acronym / sponsor ID
- E-944-16
- Conditions
- Multiple Sclerosis
- Keywords
- Employment, Self efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Wait list control
| Arm | Type | Receives |
|---|---|---|
| SEMS Project | Experimental | Behavioral: SEMS ProjectA comprehensive modular intervention consisting of wellness, fatigue management, cognitive remediation and psychological treatment. Treatment will consist of a total of 12 weeks. |
| Wait List Control | Other | Behavioral: SEMS ProjectIndividuals 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with MS based on McDonald Criteria
Key exclusion criteria (1 listed)
- any neurological condition other than MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEMS ProjectTThe 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. | Behavioural | SEMS Project, Wait List Control |
Primary outcome
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
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
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
4 secondary outcomes
Change in mood
Time frame: baseline, immediate post-intervention, 3 month post-intervention
Change in anxiety
Time frame: baseline, immediate post-intervention, 3 month post-intervention
Change in psychological well-being
Time frame: baseline, immediate post-intervention, 3 month post-intervention
Changes in stress
Time frame: baseline, immediate post-intervention, 3 month post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Strober principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
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.