NCT02920788

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Mar 2017Apr 2027

First Submitted

Initial submission to the registry

September 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

March 9, 2017

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

9.8 years

First QC Date

September 27, 2016

Last Update Submit

May 5, 2026

Conditions

Brain Injuries, Traumatic

Keywords

RehabilitationFunctional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task

    Single Test for Attention, Executive Function and Mental Flexibility

    6 months after enrollment

Study Arms (3)

Veteran Mild TBI Group - GOALS Intervention

EXPERIMENTAL

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

Behavioral: Goal-Oriented Attentional Self-Regulation (GOALS)Device: fMRI

Veteran Mild TBI - Treatment as Usual

ACTIVE COMPARATOR

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

Other: Brain Health Education (BHE)Device: fMRI

Veteran Non TBI - No Treatment

NO INTERVENTION

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)BEHAVIORAL

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.

Veteran Mild TBI Group - GOALS Intervention
Brain Health Education (BHE)OTHER

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.

Also known as: Treatment As Usual (TAU)
Veteran Mild TBI - Treatment as Usual
fMRIDEVICE

Functional Magnetic Resonance Imaging of the Brain

Veteran Mild TBI - Treatment as UsualVeteran Mild TBI Group - GOALS Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

COMPLETED

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (5)

  • Novakovic-Agopian T, Kornblith E, Abrams G, Burciaga-Rosales J, Loya F, D'Esposito M, Chen AJW. Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. J Neurotrauma. 2018 Dec 1;35(23):2784-2795. doi: 10.1089/neu.2017.5529. Epub 2018 Jul 23.

    PMID: 29717652RESULT

  • Kryza-Lacombe M, Santiago R, Hwang A, Raptentsetsang S, Maruyama BA, Chen J, Cassar M, Abrams G, Novakovic-Agopian T, Mukherjee P. Resting-State Connectivity Changes After Goal-Oriented Attentional Self-Regulation Training in Veterans With Mild Traumatic Brain Injury: Preliminary Findings from a Randomized Controlled Trial. Neurotrauma Rep. 2023 Jun 29;4(1):420-432. doi: 10.1089/neur.2022.0074. eCollection 2023.

    PMID: 37405257RESULT

  • Karbasforoushan H, Wren-Jarvis J, Hwang A, Santiago R, Raptentsetsang S, Cai LT, Xiao J, Maruyama BA, Abrams GM, Novakovic-Agopian T, Mukherjee P. Goal-Oriented Attentional Self-Regulation Training in Chronic Mild Traumatic Brain Injury is Linked to Microstructural Plasticity in Prefrontal White Matter. J Neurotrauma. 2025 Jan;42(1-2):46-56. doi: 10.1089/neu.2023.0229. Epub 2024 Oct 29.

    PMID: 39470361RESULT

  • Novakovic-Agopian T, Posecion L, Kornblith E, Abrams G, McQuaid JR, Neylan TC, Burciaga J, Joseph J, Carlin G, Groberio J, Maruyama B, Chen AJW. Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury. J Neurotrauma. 2021 Mar;38(5):582-592. doi: 10.1089/neu.2019.6806. Epub 2020 Nov 18.

    PMID: 33019861RESULT

  • Santiago R, Kryza-Lacombe M, Tessier J, Hwang A, Maruyama BA, Raptentsetsang S, Abrams G, Mukherjee P, Novakovic-Agopian T. Goal-Oriented Attentional Self-Regulation Training Improves Executive Function and Complex Attention in Veterans With mTBI-Randomized-Control Study. Arch Clin Neuropsychol. 2026 Feb 27;41(3):acaf087. doi: 10.1093/arclin/acaf087.

    PMID: 41838854RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

TherapeuticsMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Pratik Mukherjee, MD PhD

    San Francisco VA Medical Center, San Francisco, CA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pratik Mukherjee, MD PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 30, 2016

Study Start

March 9, 2017

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

April 13, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)