Improving Cognitive Rehabilitation Outcomes

Recruiting now · Not applicable

Conditions studied: Mild Traumatic Brain Injury, Posttraumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT07055633

Run by

VA Office of Research and Development

People needed

144

Starts

2026-04-01

Expected to finish

2030-09-30

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (enrolling)
• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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