Improving Cognitive Rehabilitation Outcomes

Part of paid clinical trials in San Diego, California.

Sponsor
VA Office of Research and Development
Study ID
NCT07055633
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CCT+MBLT — DEVICE
    Compensatory Cognitive Training + Morning Bright Light Therapy (Aurora LightPad)
  • CCT+ION — DEVICE
    Compensatory Cognitive Training + Negative Ion Generator (SphereOne)

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CCT+MBLT
    Compensatory Cognitive Training + Morning Bright Light Therapy
  • Sham Comparator: CCT+ION
    Compensatory Cognitive Training + Negative Ion Generator

Primary Outcome Measure

Objective Cognitive Performance [ Time Frame: baseline, 10 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Elizabeth W Twamley, PhD
[email protected]
858-552-8585
Elizabeth W. Twamley, PhD (PRINCIPAL_INVESTIGATOR)
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Maya E O'Neil, PhD
[email protected]
503-220-8262
Jonathan Elliott, PhD
[email protected]
5032208262

Find similar trials in San Diego, CA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
VA San Diego Healthcare System, San Diego, CA· San Diego, CAVA Portland Health Care System, Portland, OR· Portland, OR

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