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Mild TBI Assessment & Rehabilitation

NCT02920788 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-05-06

No results posted yet for this study

Summary

One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.

Conditions

  • Brain Injuries, Traumatic

Interventions

BEHAVIORAL

Goal-Oriented Attentional Self-Regulation (GOALS)

GOALS is a manualized, therapist-administered cognitive training program that targets executive control functions of applied mindfulness-based attention regulation and goal management strategies and links them to participant-defined real-life goals. In contrast to training via practice on isolated tasks, this training protocol involves application of attention regulation skills and strategies to participant-defined goals in real life, ecologically valid settings. One of the main training aims is to improve self-regulatory control mechanisms as they contribute to goal attainment.

OTHER

Brain Health Education (BHE)

BHE group is a formal in-person, active, psycho-educational, control intervention closely matched to GOALS for length, intensity, and contact with a therapist/facilitator. Topics include brain structure, function, sleep, stress, emotion and the brain.

DEVICE

fMRI

Functional Magnetic Resonance Imaging of the Brain

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Pratik Mukherjee, MD PhD · San Francisco VA Medical Center, San Francisco, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2026-12-31
Completion
2027-04-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02920788 on ClinicalTrials.gov