NCT04560946

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Veterans Medical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	Personalized Augmented Cognitive Training (PACT)	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.
BEHAVIORAL	Enhanced Treatment As Usual	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.

Timeline

• Start date: 2019-09-30
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2020-09-23
• Last updated: 2024-11-21

Locations

2 sites across 1 country: United States