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MENTOR Wellness Program - Trial NCT06148324

Access comprehensive clinical trial information for NCT06148324 through Pure Global AI's free database. This phase not specified trial is sponsored by NYU Langone Health and is currently Not yet recruiting. The study focuses on Traumatic Brain Injury. Target enrollment is 138 participants.

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NCT06148324
Not yet recruiting
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06148324
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MENTOR Wellness Program
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 Focus

Traumatic Brain Injury

MENTOR Program

Interventional

behavioral

Sponsor & Location

NYU Langone Health

New York, United States of America

Timeline & Enrollment

N/A

Jan 01, 2024

Aug 01, 2027

138 participants

Primary Outcome

Freiburg Mindfulness Inventory (FMI) Score at Baseline,Freiburg Mindfulness Inventory (FMI) Score at Post-Intervention Assessment,International Physical Activity Questionnaire (IPAQ) Score at Baseline,International Physical Activity Questionnaire Score at Post-Intervention Assessment,Health Promoting Lifestyle Profile II (HPLP-II) Score at Baseline,Health Promoting Lifestyle Profile II (HPLP-II) Score at Post-Intervention Assessment,Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Baseline,Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Post-Retention Assessment,Perceived Stress Scale (PSS) Score at Baseline,Perceived Stress Scale (PSS) Score at Post-Retention Assessment,Participation Assessment with Recombined Tools - Objective (PART-O) Score at Baseline,Participation Assessment with Recombined Tools - Objective (PART-O) Score at Post-Retention Assessment,Quality of Life after Brain Injury (QOLIBRI) Score at Baseline,Quality of Life after Brain Injury (QOLIBRI) Score at Post-Retention Assessment,12-Item Short Form Survey (SF-12) Score at Baseline,12-Item Short Form Survey (SF-12) Score at Post-Retention Assessment,WHO-Quality of Life - Spirituality, Religious and Personal Beliefs module (WHOQOL-SRPB BREF) Score at Baseline,WHO-Quality of Life - Spirituality, Religious and Personal Beliefs module (WHOQOL-SRPB BREF) Score at Post-Retention Assessment,Flourishing Scale Score at Baseline,Flourishing Scale Score at Post-Retention Assessment

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).

ICD-10 Classifications

Diffuse brain injury
Intracranial injury
Focal brain injury
Intracranial injury, unspecified
Other intracranial injuries

Data Source

ClinicalTrials.gov

NCT06148324

Non-Device Trial