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Recruiting NCT06148324

MENTOR Wellness Program

No phase Interventional Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MENTOR Program.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Promoting Wellness in Individuals With Traumatic Brain Injury: A Randomized Trial Assessing the Effectiveness of the Mindfulness, Exercise, Nutrition to Optimize Resilience (MENTOR) Program

Overview

This randomized trial aims to determine the effectiveness a virtual wellness intervention program in individuals with traumatic brain injury (TBI). Participants will be randomized at enrollment into two groups: immediate treatment (IT) and delayed treatment (DT) group. This study will also provide insights into the impact of these intervention's components in helping emotional, physical, and nutritional outcomes post-injury in the context of social determinants of health (SDOH).

Interventions

  • Behavioral 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.

Primary outcome measures

  • Freiburg Mindfulness Inventory (FMI) Score at Baseline [Time frame: Baseline]
  • Freiburg Mindfulness Inventory (FMI) Score at Post-Intervention Assessment [Time frame: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT)]
  • International Physical Activity Questionnaire (IPAQ) Score at Baseline [Time frame: Baseline]
  • International Physical Activity Questionnaire Score at Post-Intervention Assessment [Time frame: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT)]
  • Health Promoting Lifestyle Profile II (HPLP-II) Score at Baseline [Time frame: Baseline]
  • Health Promoting Lifestyle Profile II (HPLP-II) Score at Post-Intervention Assessment [Time frame: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT)]
  • Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Baseline [Time frame: Baseline]
  • Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Post-Retention Assessment [Time frame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)]
  • Perceived Stress Scale (PSS) Score at Baseline [Time frame: Baseline]
  • Perceived Stress Scale (PSS) Score at Post-Retention Assessment [Time frame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06148324 · 23-00826

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗