Virtual wellness program for individuals with traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial evaluates the effectiveness of a virtual wellness intervention program for individuals with traumatic brain injury (TBI). Participants will be divided into two groups: one receiving immediate treatment and the other receiving delayed treatment. The study aims to assess the impact of various components of the intervention on emotional, physical, and nutritional outcomes, while considering social determinants of health. The program is designed for individuals at least 12 months post-TBI who have access to the internet and are medically cleared to participate.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have a medically-documented (e.g., EMS report, hospital record, physician record) or per medical monitor review complicated-mild, moderate, or severe TBI requiring admission to an acute inpatient rehabilitation unit
* Be at least 12 months post-TBI
* Have access to the internet on a computer, tablet, and/or smartphone.
* Speak and understand English or Spanish
* Agree to participate
* Are medically cleared by their primary physician, physiatrist, neurologist, rehabilitation therapist, or other recognized health professional to participate in the study

Exclusion Criteria:

* No history of complicated-mild, moderate, or severe TBI
* Less than 12 months post-TBI
* In minimally conscious or vegetative state
* Beginning a new treatment regimen (e.g., physical therapy, occupational therapy, vestibular therapy, psychotherapy, and/or medication) at study start that can influence study findings in the judgment of the principal investigator and/or medical monitor (participants whose treatment regimens are stable will be eligible)
* In the judgment of the principal investigator, medical monitor, and/or study team member, presence of significant cognitive impairment (i.e. delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
* In the judgment of the principal investigator, medical monitor, and/or study team member, significant or major disabling medical condition sufficient to preclude meaningful informed consent and/or data collection

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Tamara Bushnik, PhD — NYU Langone Health
• Study coordinator: Fatima Imdad
• Email: Fatima.Imdad@nyulangone.org
• Phone: 917-376-2270

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.