Improving Cognitive Rehabilitation Outcomes

NCT07055633 | Recruiting

• 1 other identifier: RRD1-012-24W
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mild Traumatic Brain Injury; Posttraumatic Stress Disorder

Keywords

brain injury; posttraumatic stress disorder

Outcome Measures

Primary Outcomes (2)

• Objective Cognitive Performance

  Composite z score of Hopkins Verbal Learning Test-Revised; Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span; WAIS-IV Coding; Delis-Kaplan Executive Function System (D-KEFS) Trails; D-KEFS Color-Word Interference; and the UCSD Performance-Based Skills Assessment-Brief (UPSA-B). There is no minimum or maximum value of a z score. Higher scores will reflect better outcomes.

  baseline, 10 weeks

• Functioning

  Composite z score of Brief Inventory of Psychosocial Functioning and the World Health Organization Disability Assessment Schedule 2.0. There is no minimum or maximum value of a z score. Higher scores will reflect better outcomes.

  baseline, 10 weeks

Secondary Outcomes (8)

• Insomnia Severity Index

  baseline, 10 weeks

• Pittsburgh Sleep Quality Index

  baseline, 10 weeks

• Total Sleep Time

  baseline, 10 weeks

• Patient Health Questionnaire-9

  baseline, 10 weeks

• PTSD Checklist for DSM-5

  baseline, 10 weeks

Study Arms (2)

CCT+MBLT

EXPERIMENTAL

Compensatory Cognitive Training + Morning Bright Light Therapy

Device: CCT+MBLT

CCT+ION

SHAM COMPARATOR

Compensatory Cognitive Training + Negative Ion Generator

Device: CCT+ION

Interventions

CCT+MBLT DEVICE

Compensatory Cognitive Training + Morning Bright Light Therapy (Aurora LightPad)

Also known as: Morning Bright Light Therapy Aurora LightPad lightbox

CCT+MBLT

CCT+ION DEVICE

Compensatory Cognitive Training + Negative Ion Generator (SphereOne)

Also known as: SphereOne negative ion generator

CCT+ION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Portland VA Medical Center: collaborator

Study Sites (2)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

RECRUITING

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Stress Disorders, Post-Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Elizabeth W. Twamley, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Z Schy

CONTACT

(858) 255-4368; michelle.schy@va.gov

Janae R Wyckoff

CONTACT

(619) 786-4719; janae.wyckoff@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: CCT+MBLT vs CCT+ION

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 9, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)