Recruiting

Observational Study

Sponsor:

Kessler Foundation

Code:

NCT03647904

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

SEMS Project

Study Details

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

Study ID

NCT03647904

Start date

Oct 1, 2017

Status verified date

Aug, 2018

Completion date

Oct, 2018

Anticipated

Primary completion date

Oct, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • diagnosed with MS based on McDonald Criteria

Exclusion Criteria:

  • any neurological condition other than MS

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

other: 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.

Interventions

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 measure

  • Change in Work Commitment [ Time Frame: baseline, immediate post-intervention, 3 month post-intervention ]
  • Change in adjustment to MS [ Time Frame: baseline, immediate post-intervention, 3 month post-intervention ]
  • Change in self-efficacy [ Time Frame: baseline, immediate post-intervention, 3 month post-intervention ]

Central Contacts and Locations

Central contacts

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Principal Investigator:

Lauren Strober, PhD

More Information

Sponsor

Kessler Foundation

Last update posted

Aug 27, 2018

Last verified

Aug, 2018

Keywords

  • Employment
  • Self efficacy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2018-08-27.