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Improving Cognitive Rehabilitation Outcomes

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VA Office of Research and Development

Status

Begins enrollment in 8 months

Conditions

Posttraumatic Stress Disorder
Mild Traumatic Brain Injury

Treatments

Device: CCT+MBLT
Device: CCT+ION

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT07055633
RRD1-012-24W (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

144 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

144 participants in 2 patient groups

CCT+MBLT
Experimental group
Description:
Compensatory Cognitive Training + Morning Bright Light Therapy
Treatment:
Device: CCT+MBLT
CCT+ION
Sham Comparator group
Description:
Compensatory Cognitive Training + Negative Ion Generator
Treatment:
Device: CCT+ION

Trial contacts and locations

2

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Central trial contact

Amy J Jak, PhD; Elizabeth W Twamley, PhD

Data sourced from clinicaltrials.gov

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