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Recruiting NCT07055633

Improving Cognitive Rehabilitation Outcomes

No phase Interventional Mild Traumatic Brain Injury Posttraumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CCT+MBLT, CCT+ION.
Who it may be relevant to
Registry conditions: Mild Traumatic Brain Injury, Posttraumatic Stress Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Objective Cognitive Performance [Time frame: baseline, 10 weeks]
  • Functioning [Time frame: baseline, 10 weeks]
Secondary outcome measures (8)
  • Insomnia Severity Index [Time frame: baseline, 10 weeks]
  • Pittsburgh Sleep Quality Index [Time frame: baseline, 10 weeks]
  • Total Sleep Time [Time frame: baseline, 10 weeks]
  • Patient Health Questionnaire-9 [Time frame: baseline, 10 weeks]
  • PTSD Checklist for DSM-5 [Time frame: baseline, 10 weeks]
  • Neurobehavioral Symptom Inventory [Time frame: baseline, 10 weeks]
  • Subjective cognitive functioning [Time frame: baseline, 10 weeks]
  • World Health Organization Quality of Life [Time frame: baseline, 10 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • VA San Diego Healthcare System, San Diego, CA — San Diego
  • VA Portland Health Care System, Portland, OR — Portland

Identifiers

NCT: NCT07055633 · RRD1-012-24W

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗