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Improving Cognitive Rehabilitation Outcomes
NCT07055633 · VA Office of Research and Development
In plain English
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Official title
Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD
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.
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
Study design
Enrollment target: 144 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-04-01
Estimated completion: 2030-09-30
Last updated: 2026-04-24
Interventions
Device: CCT+MBLTDevice: CCT+ION
Primary outcomes
- • Objective Cognitive Performance (baseline, 10 weeks)
- • Functioning (baseline, 10 weeks)
Sponsor
VA Office of Research and Development · fed
With: Portland VA Medical Center
Contacts & investigators
ContactMichelle Z Schy · contact · michelle.schy@va.gov · (858) 255-4368
ContactJanae R Wyckoff · contact · janae.wyckoff@va.gov · (619) 786-4719
InvestigatorElizabeth W. Twamley, PhD · principal_investigator, VA San Diego Healthcare System, San Diego, CA
All locations (2)
VA San Diego Healthcare System, San Diego, CARecruiting
San Diego, California, United States
VA Portland Health Care System, Portland, ORRecruiting
Portland, Oregon, United States