Improving Cognitive Rehabilitation Outcomes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • CCT+MBLT
  • CCT+ION

Treatment groups

144 Participants
are divided into 2 treatment groups

Sponsors and collaborators

VA Office of Research and Development

Lead sponsor

Portland VA Medical Center

Collaborator