NCT06780709 · Icahn School of Medicine at Mount Sinai
Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD
(NMOSD)
What this study is about
This project aims to study whether a structured wellness program intervention can improve quality of life among people living with Neuromyelitis Optica Spectrum Disorder (NMOSD). This pilot will test a multi-modal wellness program tailored to NMOSD patients that includes services from physical therapists, dietitians, social workers, nurse practitioners and cognitive therapists.
View original scientific description
This project aims to study whether a structured wellness program intervention can improve quality of life among people living with Neuromyelitis Optica Spectrum Disorder (NMOSD). This pilot will test a multi-modal wellness program tailored to NMOSD patients that includes services from physical therapists, dietitians, social workers, nurse practitioners and cognitive therapists. The trial will be designed as a randomized controlled trial, randomizing patients to immediately starting the program as well as a 6 month delayed start. The intervention would leverage an existing clinical comprehensive MS wellness program at the Corinne Dickinson for Multiple Sclerosis (MS) at Mount Sinai Medical Center. The primary endpoint of this study would be evaluating quality of life, as assessed by MS-Quality of Life -54.
Interventions
BEHAVIORAL
Wellness Program and Behavioral Counseling
The comprehensive wellness evaluation will include initial assessments by dietician, social worker, physical therapist, nurse practitioner, and a behavioral neuropsychologist. Each provider will conduct an initial evaluation at baseline to identify areas of need and patient driven goals, as well as follow-up evaluations to evaluate implementation of changes and barriers to change.
Primary outcome measures
Multiple Sclerosis Quality of Life (MSQOL-54) Score
Time frame: at baseline, 3 months, at 6 months, at 12 months for extension study, at 18 months for extension study
The MSQOL-54 is a 54-item comprehensive patient-reported questionnaire for individuals with MS. MSQOL-54 yields two main composite scores calculated using weighted averages of relevant areas: Physical Health Composite (PHC) - the physical function, health perceptions, energy/fatigue, role limitations- physical, pain, sexual function, social function, health distress scales. The Mental Health Composite (MHC) - the health distress, overall quality of life, emotional wellbeing, role limitations- emotional, cognitive function scales. Each composite scores range from 0-100, with total scale range from 0-100. Higher scores indicating better perceived health and quality of life. Lower scores suggest poorer quality of life impacted by MS. MSQOL-54 evaluates how MS affects various aspects of a patient's life and well-being, providing valuable insights into the patient's overall health status and the impact of MS on their daily functioning.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults (age ≥18) with NMOSD diagnosed with 2015 NMOSD clinical criteria.
- All EDSS scores will be considered in order to make the intervention accessible to all patients regardless of disability.
- All patients regardless of treatment type will be considered.
Exclusion criteria
- Inability to voluntarily provide consent for study participation
- Inability to participate in study evaluation and/or endpoint measures, or participation in another concurrent randomized controlled trial or wellness based intervention.
- Any patients with a relapse within 30 days of randomization or any patients with medical restrictions on physical activity will be excluded.
- Any patients who begin stimulants and/or dalfampridine between enrollment and randomization will be excluded.
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2025 · Source of record for eligibility and locations