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NCT Number: NCT07055633

Improving Cognitive Rehabilitation Outcomes

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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Mental Disorders Nervous System Diseases Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States

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About this study

The investigators aim to compare CCT+MBLT with CCT+ION for improving cognition, functioning, and secondary outcomes in Veterans with mTBI+PTSD.

Objective cognitive performance and everyday functioning are co-primary outcomes. Depression and sleep disturbance are target mechanisms and secondary outcomes include PTSD symptom severity, post-concussive symptom severity, cognitive symptom severity, and quality of life.

Improvements in mood and sleep will be investigated as mediators. To explore for whom these interventions are most effective, the investigators will evaluate whether individual difference variables (e.g., demographics, premorbid functioning, treatment adherence) or baseline performance on primary and secondary outcome measures moderate intervention-related improvements in objective cognitive performance and everyday functioning.

The investigators will enroll a representative sample of 144 post-9/11 Veterans with mTBI+PTSD at two VA sites (San Diego and Portland). Assessments will be conducted at baseline, mid-treatment (5 weeks), post-treatment (10 weeks), and three-month follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CCT+MBLT

Device

Compensatory Cognitive Training + Morning Bright Light Therapy (Aurora LightPad)

Other names: Morning Bright Light Therapy Aurora LightPad lightbox

CCT+ION

Device

Compensatory Cognitive Training + Negative Ion Generator (SphereOne)

Other names: SphereOne negative ion generator

Primary outcomes

  1. Objective Cognitive Performance

    Time frame: baseline, 10 weeks

    Composite z score of Hopkins Verbal Learning Test-Revised; Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span; WAIS-IV Coding; Delis-Kaplan Executive Function System (D-KEFS) Trails; D-KEFS Color-Word Interference; and the UCSD Performance-Based Skills Assessment-Brief (UPSA-B). There is no minimum or maximum value of a z score. Higher scores will reflect better outcomes.

  2. Functioning

    Time frame: baseline, 10 weeks

    Composite z score of Brief Inventory of Psychosocial Functioning and the World Health Organization Disability Assessment Schedule 2.0. There is no minimum or maximum value of a z score. Higher scores will reflect better outcomes.

Secondary outcomes

  1. Insomnia Severity Index

    Time frame: baseline, 10 weeks

    Insomnia severity. Scores range from 0-28, with higher scores representing worse insomnia.

  2. Pittsburgh Sleep Quality Index

    Time frame: baseline, 10 weeks

    Sleep quality. Scores range from 0-21, with higher scores representing worse sleep quality.

  3. Total Sleep Time

    Time frame: baseline, 10 weeks

    Total Sleep Time derived from Actiwatch2. Minutes range from 0 to 1440 per day, with higher numbers reflecting more minutes of sleep.

  4. Patient Health Questionnaire-9

    Time frame: baseline, 10 weeks

    Depression symptom severity. Scores range from 0-27, with higher scores reflecting worse depression symptoms.

  5. PTSD Checklist for DSM-5

    Time frame: baseline, 10 weeks

    PTSD symptom severity. Scores range from 0-80, with higher scores reflecting worse PTSD symptoms.

  6. Neurobehavioral Symptom Inventory

    Time frame: baseline, 10 weeks

    Postconcussive symptom severity. Scores range from 0-88, with higher scores reflecting worse neurobehavioral symptoms.

  7. Subjective cognitive functioning

    Time frame: baseline, 10 weeks

    Mean score across Neuro-QOL Applied Cognition Executive Function and Neuro-QOL Applied Cognition General Concerns scales. The mean score has a range of 8-40, with higher scores reflecting better subjective cognitive functioning.

  8. World Health Organization Quality of Life

    Time frame: baseline, 10 weeks

    Quality of life. Scores range from 0-100, with higher scores reflecting better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Janae R Wyckoff

CONTACT

[email protected]

(619) 786-4719

Michelle Z Schy

CONTACT

[email protected]

(858) 255-4368

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Portland VA Medical Center

Registry information

Official study title

Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 9, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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