Mild Traumatic Brain InjuryNCT07055633
Improving Cognitive Rehabilitation Outcomes
A study testing CCT+MBLT and CCT+ION in people with Mild Traumatic Brain Injury and Posttraumatic Stress Disorder, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury, Posttraumatic Stress Disorder
- What is being tested?
- CCT+MBLT and CCT+ION
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
Maya E O'Neil, PhD, 503-220-8262 ext. 54522, maya.oneil@va.gov
Jonathan Elliott, PhD, 5032208262 ext. 51986, jonathan.elliott@va.gov
- Recruiting
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Elizabeth W Twamley, PhD, 858-552-8585 ext. 3848, etwamley@health.ucsd.edu
Elizabeth W. Twamley, PhD
About this study
Official title: Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD
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.
Read the detailed description
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.
- Being tested
- CCT+MBLT, CCT+ION
- Keywords
- brain injury, posttraumatic stress disorder
- Medical subject headings
- Brain Concussion, Stress Disorders, Post-Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCT+MBLTDevice
Also called Morning Bright Light Therapy Aurora LightPad lightbox
Compensatory Cognitive Training + Morning Bright Light Therapy (Aurora LightPad)
CCT+IONDevice
Also called SphereOne negative ion generator
Compensatory Cognitive Training + Negative Ion Generator (SphereOne)
| Study group | Role | What they receive |
|---|---|---|
| CCT+MBLT | Experimental | Compensatory Cognitive Training + Morning Bright Light Therapy Receives: Device: CCT+MBLT |
| CCT+ION | Sham comparator | Compensatory Cognitive Training + Negative Ion Generator Receives: Device: CCT+ION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Cognitive Performance
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.
Measured: baseline, 10 weeks
Functioning
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.
Measured: baseline, 10 weeks
Secondary outcomes (8)
Insomnia Severity Index
Insomnia severity. Scores range from 0-28, with higher scores representing worse insomnia.
Measured: baseline, 10 weeks
Pittsburgh Sleep Quality Index
Sleep quality. Scores range from 0-21, with higher scores representing worse sleep quality.
Measured: baseline, 10 weeks
Total Sleep Time
Total Sleep Time derived from Actiwatch2. Minutes range from 0 to 1440 per day, with higher numbers reflecting more minutes of sleep.
Measured: baseline, 10 weeks
Patient Health Questionnaire-9
Depression symptom severity. Scores range from 0-27, with higher scores reflecting worse depression symptoms.
Measured: baseline, 10 weeks
PTSD Checklist for DSM-5
PTSD symptom severity. Scores range from 0-80, with higher scores reflecting worse PTSD symptoms.
Measured: baseline, 10 weeks
Neurobehavioral Symptom Inventory
Postconcussive symptom severity. Scores range from 0-88, with higher scores reflecting worse neurobehavioral symptoms.
Measured: baseline, 10 weeks
Subjective cognitive functioning
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.
Measured: baseline, 10 weeks
World Health Organization Quality of Life
Quality of life. Scores range from 0-100, with higher scores reflecting better quality of life.
Measured: baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Apr 2026
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CCT+MBLT vs CCT+ION
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Portland VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Elizabeth W. Twamley, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055633
- Sponsor's protocol ID
- RRD1-012-24W
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD
- ClinicalTrials.gov ID
- NCT07055633
- Acronym / sponsor ID
- RRD1-012-24W
- Keywords
- brain injury, posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Portland VA Medical Center
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- CCT+MBLT vs CCT+ION
| Arm | Type | Receives |
|---|---|---|
| CCT+MBLT | Experimental | Device: CCT+MBLTCompensatory Cognitive Training + Morning Bright Light Therapy |
| CCT+ION | Sham comparator | Device: CCT+IONCompensatory Cognitive Training + Negative Ion Generator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCT+MBLTAlso: Morning Bright Light Therapy Aurora LightPad lightboxCompensatory Cognitive Training + Morning Bright Light Therapy (Aurora LightPad) | Device | CCT+MBLT |
| CCT+IONAlso: SphereOne negative ion generatorCompensatory Cognitive Training + Negative Ion Generator (SphereOne) | Device | CCT+ION |
Primary outcome
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.
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.
8 secondary outcomes
Insomnia Severity Index
Time frame: baseline, 10 weeks
Pittsburgh Sleep Quality Index
Time frame: baseline, 10 weeks
Total Sleep Time
Time frame: baseline, 10 weeks
Patient Health Questionnaire-9
Time frame: baseline, 10 weeks
PTSD Checklist for DSM-5
Time frame: baseline, 10 weeks
Neurobehavioral Symptom Inventory
Time frame: baseline, 10 weeks
Subjective cognitive functioning
Time frame: baseline, 10 weeks
World Health Organization Quality of Life
Time frame: baseline, 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth W. Twamley, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCT+MBLT and CCT+ION in people with Mild Traumatic Brain Injury and Posttraumatic Stress Disorder, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Z Schy ((858) 255-4368, michelle.schy@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Cognitive Performance (time frame: baseline, 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.