Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
study ends around
Principal Investigator
by Elizabeth W. Twamley, PhD
Headshot of Elizabeth W. Twamley
Elizabeth W. Twamley

Description

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.

Official Title

Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD

Details

The investigators aim to compare CCT+MBLT with CCT+ION for improving cognition, functioning, and secondary outcomes in Veterans with mTBI+PTSD.

Objective cognitive performance and everyday functioning are co-primary outcomes. Depression and sleep disturbance are target mechanisms and secondary outcomes include PTSD symptom severity, post-concussive symptom severity, cognitive symptom severity, and quality of life.

Improvements in mood and sleep will be investigated as mediators. To explore for whom these interventions are most effective, the investigators will evaluate whether individual difference variables (e.g., demographics, premorbid functioning, treatment adherence) or baseline performance on primary and secondary outcome measures moderate intervention-related improvements in objective cognitive performance and everyday functioning.

The investigators will enroll a representative sample of 144 post-9/11 Veterans with mTBI+PTSD at two VA sites (San Diego and Portland). Assessments will be conducted at baseline, mid-treatment (5 weeks), post-treatment (10 weeks), and three-month follow-up.

Keywords

Mild Traumatic Brain Injury, Posttraumatic Stress Disorder, brain injury, Brain Injuries, Traumatic Brain Injuries, Brain Concussion, Traumatic Stress Disorders, Post-Traumatic Stress Disorders, CCT+MBLT, CCT+ION

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • VA San Diego Healthcare System, San Diego, CA
    San Diego California 92161-0002 United States
  • VA Portland Health Care System, Portland, OR
    Portland Oregon 97207-2964 United States

Lead Scientist at UCSD

  • Elizabeth W. Twamley, PhD
    Dr. Twamley (she/her) earned a BA in Social Ecology at UC Irvine and a PhD in Clinical Psychology from Arizona State University. She completed her clinical psychology internship and postdoctoral fellowship at UCSD and joined the faculty of the Department of Psychiatry in 2003.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT07055633
Study Type
Interventional
Participants
Expecting 144 study participants
Last Updated