NCT07055633 Improving Cognitive Rehabilitation Outcomes
| NCT ID | NCT07055633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Mild Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2030-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2026-04-01 with a primary completion date of 2030-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Posttraumatic stress disorder (PTSD) and mild TBI (mTBI) frequently co-occur in post-9/11 Veterans, and together are associated with worse cognitive performance, mental health, everyday functioning, community integration, quality of life, and treatment response than either condition alone. Additional comorbidities, such as depression and sleep disturbance, are common and further exacerbate these problems. The investigators will investigate Compensatory Cognitive Training (CCT) and Morning Bright Light Therapy (MBLT) vs Negative Ion Generator (ION), to directly target cognition, depression, and sleep disturbance and to improve CCT-associated rehabilitation outcomes. The investigator's randomized controlled trial in 144 Veterans with mTBI+PTSD across two VA sites will compare cognition, functioning, and other secondary outcomes following CCT+MBLT vs. CCT+ION. This study addresses the significant gap in services and evidence-based treatments for Veterans with mTBI+PTSD.
Eligibility Criteria
Inclusion Criteria: * Post 9/11 Veterans enrolled at VA San Diego or VA Portland * Ability to provide informed consent * Living independently * History of mTBI confirmed by OSU-TBI * Current diagnosis of PTSD confirmed by CAPS-5 * Current cognitive concerns ("Do you have concerns about your cognition, thinking, attention, or memory?") * Current concern regarding depression and/or sleep disturbance; defined by a score of 5 on the PHQ-9 and/or 8 on the ISI, respectively (score of 2 or higher on ISI item 1, 2, or 3, reflecting at least "moderate" difficulty with falling asleep, staying asleep, or waking up too early in the morning) Exclusion Criteria: * Current substance use disorder with \<30 days abstinence * History of primary psychotic disorder * History of moderate to severe TBI (loss of consciousness \>30 minutes) * History of macular degeneration or bipolar disorder (both contraindicated for bright light therapy) * Not work night or swing shift schedules * Untreated obstructive sleep apnea either via self-report or a score 5 on the STOP-BANG * Current engagement in bright light therapy * Auditory or visual impairments precluding participation in assessments or treatments
Contact & Investigator
Elizabeth W. Twamley, PhD
PRINCIPAL INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA
Frequently Asked Questions
Who can join the NCT07055633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mild Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07055633 currently recruiting?
Yes, NCT07055633 is actively recruiting participants. Contact the research team at michelle.schy@va.gov for enrollment information.
Where is the NCT07055633 trial being conducted?
This trial is being conducted at San Diego, United States, Portland, United States.
Who is sponsoring the NCT07055633 clinical trial?
NCT07055633 is sponsored by VA Office of Research and Development. The principal investigator is Elizabeth W. Twamley, PhD at VA San Diego Healthcare System, San Diego, CA. The trial plans to enroll 144 participants.