Clinical trial NCT04560946: Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans with a History of TBI
Official title: Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans with a History of TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
cognitive rehabilitation
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: United States Naval Medical Center, San Diego
First posted: 2020-09-23
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized controlled trial.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Neurobehavioral Symptom Inventory (NSI)
timeFrame: 6, 12 weeks
Secondary outcomes:
measure: Change in UCSD Performance-Based Skills Assessment-B (UPSA-B)
timeFrame: 6, 12 weeks
measure: Change in WMS-IV Digit Span
timeFrame: 6, 12 weeks
measure: Change in California Verbal Learning Test-III (CVLT-III)
timeFrame: 6, 12 weeks
measure: Change in D-KEFS Verbal Fluency
timeFrame: 6, 12 weeks
measure: Change in Oral Trails
timeFrame: 6, 12 weeks
measure: Change in Test My Brain Continuous Performance Test
timeFrame: 6, 12 weeks
measure: Change in Test My Brain Matrix Reasoning
timeFrame: 6, 12 weeks
measure: Change in Test My Brain Digit Symbol Matching
timeFrame: 6, 12 weeks
measure: Change in Test My Brain Choice Reaction Time
timeFrame: 6, 12 weeks
measure: Change in the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6, 12 weeks
measure: Change in Cognitive Problems and Strategies Assessment
timeFrame: 6, 12 weeks
measure: Change in Patient Global Impression of Change (PGIC)
timeFrame: 6, 12 weeks
measure: Change in Traumatic Brain Injury Quality of Life (TBI-QoL)
timeFrame: 6, 12 weeks
measure: Change in WHO Disability Assessment Schedule (WHODAS) 2.0 (plus supplementary questions for duty status, work/school)
timeFrame: 6, 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: Veterans Medical Research Foundation
name: Elizabeth W Twamley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Veterans Medical Research Foundation
name: Mark L Ettenhofer, PhD
role: PRINCIPAL_INVESTIGATOR
References: