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Improving Cognitive Rehabilitation Outcomes

RecruitingNAAges 18 Years - anyAllVA Office of Research and Development
NCT07055633 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 signi

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📋 Eligibility rules (as published)
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
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What it tests

  • CCT+MBLT
  • CCT+ION
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Where

2 sites
VA San Diego Healthcare System, San Diego, CA
San Diego, United States
VA Portland Health Care System, Portland, OR
Portland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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