Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
144 participants
INTERVENTIONAL
2026-04-01
2030-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CCT+MBLT
Compensatory Cognitive Training + Morning Bright Light Therapy
CCT+MBLT
Compensatory Cognitive Training + Morning Bright Light Therapy (Aurora LightPad)
CCT+ION
Compensatory Cognitive Training + Negative Ion Generator
CCT+ION
Compensatory Cognitive Training + Negative Ion Generator (SphereOne)
Interventions
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CCT+MBLT
Compensatory Cognitive Training + Morning Bright Light Therapy (Aurora LightPad)
CCT+ION
Compensatory Cognitive Training + Negative Ion Generator (SphereOne)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Portland VA Medical Center
FED
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Elizabeth W. Twamley, PhD
Role: PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA
Locations
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VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RRD1-012-24W
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RRD1-012-24W
Identifier Type: -
Identifier Source: org_study_id
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