Recruiting

Cognitive Training

Sponsor:

VA Office of Research and Development

Code:

NCT02920788

Conditions

Brain Injuries, Traumatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Goal-Oriented Attentional Self-Regulation (GOALS)

Brain Health Education (BHE)

fMRI

Study Details

Brief 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

Study ID

NCT02920788

Start date

Mar 9, 2017

Status verified date

May, 2026

Completion date

Apr 13, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Veteran Mild TBI Group - GOALS Intervention

Veterans ages 18+ with chronic mild TBI, to undergo GOALS cognitive training as an intervention.

active comparator: Veteran Mild TBI - Treatment as Usual

Veterans ages 18+ with chronic mild TBI, matched by demographic and clinical criteria to the GOALS group, to receive the standard clinical care.

no intervention: Veteran Non TBI - No Treatment

Veterans ages 18+ with no history of TBI, to undergo Neuropsychologic evaluation and MR Imaging with no intervention.

Interventions

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.

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.

fMRI

Functional Magnetic Resonance Imaging of the Brain

Primary outcome measure

  • Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task [ Time Frame: 6 months after enrollment ]

Central Contacts and Locations

Central contacts

Pratik Mukherjee, MD PhD

(415) 353-9364pratik.mukherjee@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Pratik Mukherjee, MD

415-353-8972pratik.mukherjee@ucsf.edu

Tatjana Novakovic-Agopian

4157533888Tatjana.Novakovic-agopian@ucsf.edu

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Rehabilitation
  • Functional Magnetic Resonance Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-06.