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Search / Trial NCT07055633

Improving Cognitive Rehabilitation Outcomes

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jul 8, 2025

Trial Information

Current as of July 24, 2025

Not yet recruiting

Keywords

Brain Injury Posttraumatic Stress Disorder

ClinConnect Summary

This clinical trial is studying ways to help Veterans who have both mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD), conditions that often occur together and can make thinking, mood, sleep, and daily life more challenging. The researchers want to see if combining two treatments—Compensatory Cognitive Training (which teaches strategies to improve thinking and memory) and Morning Bright Light Therapy (which uses light exposure to help with mood and sleep)—works better than cognitive training combined with a placebo device. The goal is to improve thinking skills, reduce depression and sleep problems, and overall help Veterans function better in their daily lives.

Veterans who served after 9/11, have a history of mild brain injury, a current diagnosis of PTSD, and concerns about thinking, mood, or sleep might be eligible to join. Participants need to be living independently and able to give consent. The study will include 144 Veterans at two VA medical centers but is not yet recruiting. If you join, you can expect to take part in cognitive training sessions and either receive bright light therapy or a comparison device, with researchers measuring how these treatments affect your thinking, mood, and daily functioning. Certain conditions, like more severe brain injuries, untreated sleep apnea, or specific eye or mental health issues, might prevent someone from joining. This study aims to fill an important gap in treatments for Veterans facing these combined challenges.

Gender

ALL

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

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

San Diego, California, United States

Portland, Oregon, United States

Patients applied

0 patients applied

Trial Officials

Elizabeth W. Twamley, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported