Improving thinking, daily functioning, mood, and sleep after mild traumatic brain injury and PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.