Improving cognitive skills for Veterans with brain injuries
Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
This study is testing two different training programs using online tools to see if they can help Veterans with brain injuries improve their thinking skills for work and school.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04109027 on ClinicalTrials.gov |
What this trial studies
This project focuses on helping Veterans who have experienced traumatic brain injuries (TBI) improve their cognitive skills necessary for success in various life areas, such as work and school. It utilizes tele-rehabilitation and digital apps to deliver two different training approaches: one that educates Veterans about brain health and another that teaches skills for regulating cognitive-emotional functioning. Participants will be randomly assigned to one of the two interventions and will undergo assessments before, immediately after, and three months following the training. The study aims to enhance access to rehabilitation services for Veterans in their communities.
Who should consider this trial
Good fit: Ideal candidates are post 9/11 Veterans aged 21-60 with a history of mild to moderate TBI and self-reported cognitive symptoms.
Not a fit: Patients with severe cognitive dysfunction, neurological disorders, or those unable to participate due to severe apathy or other mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve cognitive functioning and goal achievement for Veterans with TBI.
How similar studies have performed: Similar studies utilizing tele-rehabilitation for cognitive improvement in TBI have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Sacramento, California
- VA Northern California Health Care System, Mather, CA — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Anthony J. W. Chen, MD MA — VA Northern California Health Care System, Mather, CA
- Study coordinator: Jeanette M Cope
- Email: Jeanette.Cope@va.gov
- Phone: (916) 843-7512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.