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Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
VA San Diego Healthcare System, San Diego, CA
RECRUITING
San Diego
Oregon
VA Portland Health Care System, Portland, OR
RECRUITING
Portland
Contact Information
Primary
Michelle Z Schy
michelle.schy@va.gov
(858) 255-4368
Backup
Janae R Wyckoff
janae.wyckoff@va.gov
(619) 786-4719
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2030-09-30
Participants
Target number of participants: 144
Treatments
Experimental: CCT+MBLT
Compensatory Cognitive Training + Morning Bright Light Therapy
Sham_comparator: CCT+ION
Compensatory Cognitive Training + Negative Ion Generator
Sponsors
Leads: VA Office of Research and Development
Collaborators: Portland VA Medical Center

This content was sourced from clinicaltrials.gov