Improving thinking, daily functioning, mood, and sleep after mild traumatic brain injury and PTSD
Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD
This project will test whether adding morning bright light therapy to compensatory cognitive training helps post-9/11 Veterans with mild traumatic brain injury and PTSD think, function, and sleep better compared with a neutral ion generator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT07055633 on ClinicalTrials.gov |
What this trial studies
This randomized study will enroll 144 post-9/11 Veterans with co-occurring mild TBI and PTSD at two VA sites (San Diego and Portland) and randomize them to compensatory cognitive training plus morning bright light therapy (CCT+MBLT) versus compensatory cognitive training plus a negative ion generator (CCT+ION). Objective cognitive performance and everyday functioning are co-primary outcomes, with depression and sleep disturbance specified as target mechanisms and secondary outcomes including PTSD symptoms, post-concussive symptoms, cognitive symptom severity, and quality of life. Participants will be assessed at baseline, mid-treatment (5 weeks), post-treatment (10 weeks), and at a three-month follow-up to measure change over time. The study will also test whether improvements in mood and sleep mediate cognitive and functional gains and whether individual differences moderate response.
Who should consider this trial
Good fit: Post-9/11 Veterans enrolled at VA San Diego or VA Portland who live independently, can give informed consent, have a confirmed history of mild TBI and current PTSD, report cognitive concerns, and have current depression and/or moderate sleep disturbance are ideal candidates.
Not a fit: People with moderate-to-severe TBI, primary psychotic disorder, recent substance use disorder (<30 days abstinence), macular degeneration or bipolar disorder (contraindications to bright light), night or swing shift workers, or those unable to attend the VA San Diego or Portland sites are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the combined approach could improve thinking, daily functioning, mood, and sleep for Veterans with mTBI+PTSD and lead to better quality of life.
How similar studies have performed: Components of the approach—compensatory cognitive training and morning bright light—have shown benefit separately for cognition, mood, or sleep in prior work, but combining them specifically for Veterans with mTBI+PTSD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California and 1 other locations
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (Recruiting)
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth W. Twamley, PhD — VA San Diego Healthcare System, San Diego, CA
- Study coordinator: Michelle Z Schy
- Email: michelle.schy@va.gov
- Phone: (858) 255-4368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.