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Completed

NCT Number: NCT04560946

Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans with a History of TBI

Mild traumatic brain injury (TBI) is a common medical condition that occurs when a head injury causes someone to lose consciousness, feel dazed or confused, or be unable to remember events occurring immediately after the injury. While most individuals with mild TBI recover within weeks or months, some individuals with mild TBI report chronic symptoms such as difficulty with cognitive skills like attention, learning, or memory, along with other symptoms such as irritability or headache. Previous studies, including those conducted by our scientific team, have shown that cognitive rehabilitation can help patients with persistent symptoms after mild TBI return to full duty, work, school, and other important life activities. Specifically, cognitive rehabilitation can provide lasting improvements in thinking abilities, functional capacity, post-concussive symptoms, and quality of life after mild TBI. However, effective interventions are still out of reach for many service members and Veterans with TBI. For patients who have returned to duty, employment, or education, scheduling up to 60 hours of treatment (a typical treatment schedule in many settings) may not be feasible. Additionally, some patients may live in areas where it is burdensome to make numerous visits to a medical center. Personalized Augmented Cognitive Training (PACT) compresses treatment into six hours of once-weekly personalized, one-on-one training by selecting treatment modules based on patient needs and priorities-substantially reducing the total amount of time required to complete treatment. PACT can be offered either in-person (in clinic) or via home-based video telemedicine, depending upon patients' preferences. Additionally, PACT includes training and encouragement for service members and Veterans to make self-directed use of mobile apps that train cognitive skills and strategies.The primary goal of this study is to evaluate whether PACT is effective at improving cognition, symptoms, and functional outcomes among military service members and Veterans with a history of mild TBI. The study will also yield information about factors that can enhance or interfere with treatment, such as number of previous TBIs, presence of post-traumatic stress; and choice of in-person vs. video telemedicine delivery of care.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All participants:

  • Male or female
  • All racial and ethnic groups
  • Ages 18 to 55
  • Veteran or service member
  • History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBIID method)
  • Score of ≥4 on the cognitive subscale of the Neurobehavioral Symptom Inventory reflecting 'very severe' symptoms in at least one area or at least 'mild' symptoms in all four areas surveyed
  • have a compatible device (computer, tablet, or smartphone) with internet connection (wifi or cellular plan).

Exclusion criteria

  • Mild TBI sustained < 3 months previously
  • History of moderate, severe, or penetrating TBI
  • History of other neurological condition unrelated to TBI
  • Current psychiatric disturbance that would preclude study participation (e.g. clinically significant mania or psychosis)
  • Current substance use disorder
  • Current, active suicidal or homicidal ideation
  • Current use of benzodiazepines or medications with anticholinergic effects
  • Not stable on psychiatric medications for at least 6 weeks
  • Impaired decision making capacity
  • Unable to provide voluntary informed consent
  • Previously completed >4 sessions of cognitive rehabilitation

Treatment and study plan

Personalized Augmented Cognitive Training (PACT)

Behavioral

Personalized Augmented Cognitive Training (PACT) group. Intervention: Behavioral: The study neuropsychologist will use a portion of the TBI education session to describe available treatment modules and make recommendations for module selection based on results from baseline assessment. After discussion, five 60-minute CogSMART modules will be selected. PACT participants will receive guidance to complete 2 modules per week of the CogSMART app. PACT participants will also receive guidance to complete BrainHQ exercises of their choice for 30 minutes a day, 5 days per week, for a total training time of 15 hours.

Enhanced Treatment as Usual

Behavioral

Enhanced Treatment As Usual (ETAU) group. Intervention: Behavioral: The ETAU condition was designed to replicate treatment as usual following neuropsychological assessment of post-TBI cognitive problems. Treatment as usual for mTBI patients at the VA hospital usually consists of: 1) A general evaluation by the polytrauma clinic, 2) Possible neuropsychological assessment evaluation by the TBI Cognitive Rehabilitation Clinic, and 3) If impairments are present, cognitive rehabilitation is offered. The current study's condition is considered "enhanced" treatment as usual because standard of care for chronic mTBI does not always involve neuropsychological assessment with feedback and psychoeducation or the provision of self-directed tools such as the CogSMART app or BrainHQ cognitive training software.

Primary outcomes

  1. Change in the Neurobehavioral Symptom Inventory (NSI)

    Time frame: 6, 12 weeks

    Measure of post concussive symptoms

Secondary outcomes

  1. Change in UCSD Performance-Based Skills Assessment-B (UPSA-B)

    Time frame: 6, 12 weeks

    Measure of everyday communication and financial capacity

  2. Change in WMS-IV Digit Span

    Time frame: 6, 12 weeks

    Measure of verbal working memory

  3. Change in California Verbal Learning Test-III (CVLT-III)

    Time frame: 6, 12 weeks

    Measure of verbal and learning memory

  4. Change in D-KEFS Verbal Fluency

    Time frame: 6, 12 weeks

    Measure of executive function

  5. Change in Oral Trails

    Time frame: 6, 12 weeks

    Measure of visual psychomotor, and executive processes

  6. Change in Test My Brain Continuous Performance Test

    Time frame: 6, 12 weeks

    Measure of sustained attention

  7. Change in Test My Brain Matrix Reasoning

    Time frame: 6, 12 weeks

    Measure of visual reasoning

  8. Change in Test My Brain Digit Symbol Matching

    Time frame: 6, 12 weeks

    Measure of visual scanning and information processing speed

  9. Change in Test My Brain Choice Reaction Time

    Time frame: 6, 12 weeks

    Measure of reaction time

  10. Change in the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 6, 12 weeks

    Measure of sleep quality and disturbances over the past month

  11. Change in Cognitive Problems and Strategies Assessment

    Time frame: 6, 12 weeks

    Measure of frequency of use of common strategies to enhance cognitive performance, as well as perceived cognitive problems

  12. Change in Patient Global Impression of Change (PGIC)

    Time frame: 6, 12 weeks

    Measure of activity limitations, symptoms, and overall quality of life

  13. Change in Traumatic Brain Injury Quality of Life (TBI-QoL)

    Time frame: 6, 12 weeks

    Measure of patient reported outcomes and NINDS CDEs for TBI

  14. Change in WHO Disability Assessment Schedule (WHODAS) 2.0 (plus supplementary questions for duty status, work/school)

    Time frame: 6, 12 weeks

    Measure of function in the following areas: life activities (work, school, domestic responsibilities), cognition, mobility, self-care, social, and community participation. To supplement the WHODAS 2.0, we will also ask supplemental questions regarding current duty status (for military service members), and number of hours of work/school per week

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • United States Naval Medical Center, San Diego

Registry information

Acronym: PACT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2020
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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