Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
138 participants
INTERVENTIONAL
2024-04-11
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate treatment (IT)
Participants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period.
MENTOR Program
MENTOR is an online wellness program covering 11 wellness modules: Exercise; Nutrition; Mindfulness; Spiritual Practice; Self-Care; Arts \& Leisure; Rest \& Relaxation; Outdoors in Nature; Relationships; Core Values; and Contribution to Others.
The 8-week cycle comprises 40 hours of online group-based instruction and discussion, meeting up to five times per week.
Delayed treatment (DT)
Participants randomized to the DT arm will have an 8-week waitlist period prior to starting the 8-week MENTOR program, followed by an 8-week retention period.
MENTOR Program
MENTOR is an online wellness program covering 11 wellness modules: Exercise; Nutrition; Mindfulness; Spiritual Practice; Self-Care; Arts \& Leisure; Rest \& Relaxation; Outdoors in Nature; Relationships; Core Values; and Contribution to Others.
The 8-week cycle comprises 40 hours of online group-based instruction and discussion, meeting up to five times per week.
Interventions
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MENTOR Program
MENTOR is an online wellness program covering 11 wellness modules: Exercise; Nutrition; Mindfulness; Spiritual Practice; Self-Care; Arts \& Leisure; Rest \& Relaxation; Outdoors in Nature; Relationships; Core Values; and Contribution to Others.
The 8-week cycle comprises 40 hours of online group-based instruction and discussion, meeting up to five times per week.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Institute on Disability, Independent Living, and Rehabilitation Research
FED
University of Alabama at Birmingham
OTHER
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Tamara Bushnik, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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23-00826
Identifier Type: -
Identifier Source: org_study_id
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