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

NCT04109027 | Recruiting

• 1 other identifier: N3141-R
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TBI; Cognitive Dysfunction

Keywords

attention; working memory; executive functioning

Outcome Measures

Primary Outcomes (1)

• Selective Information Processing

  In order to test a primary hypothesis related to potential intervention mechanisms, the investigators will use the well-established Automated Operation Span Task (OSPAN) to measure working memory in the presence of distractions. Specifically, the OSPAN sums correctly recalled and ordered items from a memory set in the presence of distractors. The investigators elected to use this psychometric measure due to its sensitivity, precision, and test-retest stability in order to maximize the ability to detect longitudinal changes on the primary outcome of interest.

  Change from baseline to 2 weeks post-intervention

Secondary Outcomes (2)

• Observed Functional performance

  2 weeks post-intervention, 3 months post-intervention

• Progress Towards Goal Attainment

  3 months post-intervention

Study Arms (2)

BrainStrong-GSR

EXPERIMENTAL

Goal-directed State Regulation Training (GSR)

Behavioral: BrainStrong-GSR

BrainStrong-OPT

ACTIVE COMPARATOR

Optimization of Brain Functioning (OPT)

Behavioral: BrainStrong-OPT

Interventions

BrainStrong-GSR BEHAVIORAL

Goal-directed State Regulation Training (GSR)

Also known as: Goal-directed State Regulation Training (GSR)

BrainStrong-GSR

BrainStrong-OPT BEHAVIORAL

Optimization of Brain Functioning (OPT)

Also known as: Optimization of Brain Functioning (OPT)

BrainStrong-OPT

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Post 9/11 Veterans
• age 21-60; with history of mild-moderate TBI (including reported mechanism of head injury and alteration of consciousness);
• in the chronic, stable phase of recovery (\>6 months from injury); with at least 1 self-reported cognitive symptom, --including difficulties with working memory; and interested in goal-setting and intensive training.

You may not qualify if:

• Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate in training;
• severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains);
• schizophrenia;
• bipolar disorder;
• history of other neurological disorders;
• current medical illnesses that may alter mental status or disrupt participation in the study;
• active psychotropic medication changes;
• symptom magnification or malingering.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655-4200, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anthony J. W. Chen, MD MA

  VA Northern California Health Care System, Mather, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanette M Cope

CONTACT

(916) 843-7512; Jeanette.Cope@va.gov

Juliana V Baldo, PhD

CONTACT

(925) 372-4649; Juliana.Baldo@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors and investigators will be blinded to study arm. Participants will have equal expectations of learning and benefit from the two active comparisons, though they cannot be blinded to the content of the training interventions. Trainers will have to be aware of the training content.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized trial with two active comparison interventions

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: June 10, 2024
• Primary Completion: March 9, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)