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

Veterans Medical Research Foundation

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Behavioral: Enhanced Treatment As Usual; Behavioral: Personalized Augmented Cognitive Training (PACT)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04560946

W81XWH1910656

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All participants:

1. Male or female
2. All racial and ethnic groups
3. Ages 18 to 55
4. Veteran or service member
5. History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBIID method)
6. 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
7. have a compatible device (computer, tablet, or smartphone) with internet connection (wifi or cellular plan).

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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107 participants in 2 patient groups

PACT

Experimental group

Description:

Personalized Augmented Cognitive Training (PACT)

Treatment:

Behavioral: Personalized Augmented Cognitive Training (PACT)

ETAU

Active Comparator group

Description:

Enhanced Treatment As Usual (ETAU)

Treatment:

Behavioral: Enhanced Treatment As Usual