MENTOR Wellness Program

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06148324
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • MENTOR Program — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Apr 11, 2024
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate treatment (IT)
    Participants randomized to the IT arm will receive the 8-week MENTOR program, followed by an 8-week retention period.
  • Experimental: 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.

Primary Outcome Measure

Freiburg Mindfulness Inventory (FMI) Score at Baseline [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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