Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07055633

Improving Cognitive Rehabilitation Outcomes

Led by VA Office of Research and Development · Updated on 2026-04-24

144

Participants Needed

2

Research Sites

234 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

P

Portland VA Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Improving Cognitive Rehabilitation Outcomes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Post 9/11 Veterans enrolled at VA San Diego or VA Portland
  • Ability to provide informed consent
  • Living independently
  • History of mild traumatic brain injury confirmed by OSU-TBI
  • Current diagnosis of PTSD confirmed by CAPS-5
  • Current cognitive concerns about thinking, attention, or memory
  • Current concern regarding depression and/or sleep disturbance defined by PHQ-9 score of 5 and/or ISI score of 8, including at least moderate difficulty falling asleep, staying asleep, or waking too early
Not Eligible

You will not qualify if you...

  • Current substance use disorder with less than 30 days abstinence
  • History of primary psychotic disorder
  • History of moderate to severe traumatic brain injury with loss of consciousness longer than 30 minutes
  • History of macular degeneration or bipolar disorder (contraindicated for bright light therapy)
  • Working night or swing shift schedules
  • Untreated obstructive sleep apnea by self-report or STOP-BANG score of 5
  • Current engagement in bright light therapy
  • Auditory or visual impairments that prevent participation in assessments or treatments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States, 92161-0002

Actively Recruiting

2

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States, 97207-2964

Actively Recruiting

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Research Team

M

Michelle Z Schy

CONTACT

J

Janae R Wyckoff

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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