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Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD

RecruitingNAAges 18 Years - anyAllIcahn School of Medicine at Mount Sinai
NCT06780709 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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: * Age\<18 * 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.
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What it tests

  • Wellness Program and Behavioral Counseling
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Where

1 site
Corinne Goldsmith Dickinson Center for MS at Mount Sinai
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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