Recruiting

CCT & MBLT

Sponsor:

VA Office of Research and Development

Code:

NCT07055633

Conditions

Mild Traumatic Brain Injury

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CCT+MBLT

CCT+ION

Study Details

Brief summary:

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

Mild Traumatic Brain Injury

Posttraumatic Stress Disorder

Study ID

NCT07055633

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CCT+MBLT

Compensatory Cognitive Training + Morning Bright Light Therapy

sham comparator: CCT+ION

Compensatory Cognitive Training + Negative Ion Generator

Interventions

CCT+MBLT

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

CCT+ION

Compensatory Cognitive Training + Negative Ion Generator (SphereOne)

Primary outcome measure

  • Objective Cognitive Performance [ Time Frame: baseline, 10 weeks ]
  • Functioning [ Time Frame: baseline, 10 weeks ]

Central Contacts and Locations

Central contacts

Michelle Z Schy

(858) 255-4368michelle.schy@va.gov

Janae R Wyckoff

(619) 786-4719janae.wyckoff@va.gov

Locations

VA San Diego Healthcare System, San Diego, CA

Recruiting

San Diego, California, United States, 92161-0002

Contacts

Elizabeth W Twamley, PhD

858-552-8585etwamley@health.ucsd.edu

Principal Investigator:

Elizabeth W. Twamley, PhD

VA Portland Health Care System, Portland, OR

Recruiting

Portland, Oregon, United States, 97207-2964

Contacts

Maya E O'Neil, PhD

503-220-8262maya.oneil@va.gov

Jonathan Elliott, PhD

5032208262jonathan.elliott@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • brain injury
  • posttraumatic stress disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-24.