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ACTIVE NOT RECRUITING

NCT02920788

Mild TBI Assessment & Rehabilitation

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Multi-Level Assessment and Rehabilitation of Combat Mild TBI

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2017-03-09

Completion Date

2026-04-30

Last Updated

2025-11-10

Healthy Volunteers

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

Inclusion Criteria: For TBI-positive veteran participants, to be randomized to either GOALS or TAU: * Ages 18+ * A history of mild TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument) * Chronic, stable phase of recovery (\>6 months from last post-concussive event) * Report of residual cognitive difficulties (1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI)) that interfere(s) with daily function * Able and willing to commit to participate in training and assessments * If on psychoactive medications, must be stable on medications (\> 30 days) For the TBI-negative healthy veteran control group: * Ages 18+ * No history of any (mild to severe) TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument) * Able and willing to commit to participate in assessments * If on psychoactive medications, must be stable on medications (\> 30 days) Exclusion Criteria: For the TBI-positive veteran participants, to be randomized to either GOALS or TAU: * A history of moderate or severe TBI * Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g., contraindications to MRI) * Ongoing illicit drug or alcohol abuse (AUDIT\>8) * Psychosis * Severe depression, anxiety or PTSD that precludes participation in research activities * Poor English comprehension * Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD * There will be no restriction in regard to gender, race and socioeconomic status For the TBI-negative healthy veteran control group: * A history of any mild, moderate, or severe TBI * Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g. contraindications to MRI) * Ongoing illicit drug or alcohol abuse (AUDIT\>8) * Psychosis * Severe depression, anxiety or PTSD that precludes participation in research activities * Poor English comprehension * Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD. * There will be no restriction in regard to gender, race and socioeconomic status

Locations (2)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

University of California, San Francisco