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

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: Enhanced Treatment As Usual; Behavioral: Personalized Augmented Cognitive Training (PACT)

• Registration Number: NCT04560946
• Lead Sponsor: Veterans Medical Research Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-30
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Status Verified: 2023-04
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETAU	Enhanced Treatment As Usual	Enhanced Treatment As Usual (ETAU)
PACT	Personalized Augmented Cognitive Training (PACT)	Personalized Augmented Cognitive Training (PACT)

Primary Outcome Measures

Name	Time	Method
Change in the Neurobehavioral Symptom Inventory (NSI)	6, 12 weeks	Measure of post concussive symptoms

Secondary Outcome Measures

Name	Time	Method
Change in UCSD Performance-Based Skills Assessment-B (UPSA-B)	6, 12 weeks	Measure of everyday communication and financial capacity
Change in California Verbal Learning Test-III (CVLT-III)	6, 12 weeks	Measure of verbal and learning memory
Change in D-KEFS Verbal Fluency	6, 12 weeks	Measure of executive function
Change in Oral Trails	6, 12 weeks	Measure of visual psychomotor, and executive processes
Change in Test My Brain Continuous Performance Test	6, 12 weeks	Measure of sustained attention
Change in Test My Brain Matrix Reasoning	6, 12 weeks	Measure of visual reasoning
Change in Test My Brain Choice Reaction Time	6, 12 weeks	Measure of reaction time
Change in the Pittsburgh Sleep Quality Index (PSQI)	6, 12 weeks	Measure of sleep quality and disturbances over the past month
Change in Cognitive Problems and Strategies Assessment	6, 12 weeks	Measure of frequency of use of common strategies to enhance cognitive performance, as well as perceived cognitive problems
Change in Patient Global Impression of Change (PGIC)	6, 12 weeks	Measure of activity limitations, symptoms, and overall quality of life
Change in Traumatic Brain Injury Quality of Life (TBI-QoL)	6, 12 weeks	Measure of patient reported outcomes and NINDS CDEs for TBI
Change in WHO Disability Assessment Schedule (WHODAS) 2.0 (plus supplementary questions for duty status, work/school)	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
Change in WMS-IV Digit Span	6, 12 weeks	Measure of verbal working memory
Change in Test My Brain Digit Symbol Matching	6, 12 weeks	Measure of visual scanning and information processing speed

Trial Locations

Locations (2)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States