Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond

Part of paid clinical trials in Sacramento, California.

Sponsor
VA Office of Research and Development
Study ID
NCT04109027
Status
Recruiting
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Conditions

  • Cognitive Dysfunction
  • TBI

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • BrainStrong-GSR — BEHAVIORAL
    Goal-directed State Regulation Training (GSR)
  • BrainStrong-OPT — BEHAVIORAL
    Optimization of Brain Functioning (OPT)

Study Details

For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain injury (TBI) often struggle with these very abilities, and a number of barriers can make it difficult for them to access the help Veterans need. Tele-rehabilitation has the potential to overcome some of these barriers and increase access to care, enabling providers to better reach Veterans 'where they are' in their communities. This project will assess two different approaches to brain injury rehabilitation that seek to help Veterans build personal strengths to better accomplish their goals. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps to best support Veterans' learning in community settings outside the VA.

Key Dates

Start date
Jun 10, 2024
Status verified
Nov 2025
Primary completion
Mar 9, 2026
Completion
May 25, 2026

Study Design

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

Arms

  • Experimental: BrainStrong-GSR
    Goal-directed State Regulation Training (GSR)
  • Active Comparator: BrainStrong-OPT
    Optimization of Brain Functioning (OPT)

Primary Outcome Measure

Selective Information Processing [ Time Frame: Change from baseline to 2 weeks post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Northern California Health Care System, Mather, CASacramentoCalifornia95655-4200
Jefferson Lee
[email protected]
(916) 843-2769
Lucita E Echaluse, BSN
[email protected]
(916) 843-7195
Anthony J. W. Chen, MD MA (PRINCIPAL_INVESTIGATOR)

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By research site
VA Northern California Health Care System, Mather, CA· Sacramento, CA

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