Clinical trial NCT06148324: MENTOR Wellness Program
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
TBI
brain injury
wellness
physical activity
nutrition
chronic
mindfulness
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
name: University of Alabama at Birmingham
First posted: 2023-11-28
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


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

Primary outcomes:
measure: Freiburg Mindfulness Inventory (FMI) Score at Baseline
timeFrame: Baseline
measure: Freiburg Mindfulness Inventory (FMI) Score at Post-Intervention Assessment
timeFrame: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT)
measure: International Physical Activity Questionnaire (IPAQ) Score at Baseline
timeFrame: Baseline
measure: International Physical Activity Questionnaire Score at Post-Intervention Assessment
timeFrame: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT)
measure: Health Promoting Lifestyle Profile II (HPLP-II) Score at Baseline
timeFrame: Baseline
measure: Health Promoting Lifestyle Profile II (HPLP-II) Score at Post-Intervention Assessment
timeFrame: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT)
measure: Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Baseline
timeFrame: Baseline
measure: Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Post-Retention Assessment
timeFrame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
measure: Perceived Stress Scale (PSS) Score at Baseline
timeFrame: Baseline
measure: Perceived Stress Scale (PSS) Score at Post-Retention Assessment
timeFrame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
measure: Participation Assessment with Recombined Tools - Objective (PART-O) Score at Baseline
timeFrame: Baseline
measure: Participation Assessment with Recombined Tools - Objective (PART-O) Score at Post-Retention Assessment
timeFrame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
measure: Quality of Life after Brain Injury (QOLIBRI) Score at Baseline
timeFrame: Baseline
measure: Quality of Life after Brain Injury (QOLIBRI) Score at Post-Retention Assessment
timeFrame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
measure: 12-Item Short Form Survey (SF-12) Score at Baseline
timeFrame: Baseline
measure: 12-Item Short Form Survey (SF-12) Score at Post-Retention Assessment
timeFrame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
measure: WHO-Quality of Life - Spirituality, Religious and Personal Beliefs module (WHOQOL-SRPB BREF) Score at Baseline
timeFrame: Baseline
measure: WHO-Quality of Life - Spirituality, Religious and Personal Beliefs module (WHOQOL-SRPB BREF) Score at Post-Retention Assessment
timeFrame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
measure: Flourishing Scale Score at Baseline
timeFrame: Baseline
measure: Flourishing Scale Score at Post-Retention Assessment
timeFrame: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Tamara Bushnik, PhD
role: PRINCIPAL_INVESTIGATOR
References: