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

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.

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Personalized Augmented Cognitive Training (PACT); Behavioral: Enhanced Treatment As Usual

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth W Twamley, PhD; Phone Number: (858) 642-3848; Email: Elizabeth.Twamley@va.gov
• Study Contact Backup: Name: Mark L Ettenhofer, PhD; Phone Number: (619) 532-6601; Email: Mark.L.Ettenhofer.ctr@mail.mil

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Recruiting
      • Naval Medical Center San Diego
      • Contact: Mark L Ettenhofer, PhD; Phone Number: 619-532-6601; Email: Mark.L.Ettenhofer.ctr@mail.mil
      • Contact: Angelica D Aguirre, MPH, CCRC; Phone Number: 619-532-6132; Email: angelica.d.aguirre2.ctr@mail.mil
    • San Diego, California, United States, 92161
      • Recruiting
      • VA San Diego Healthcare System
      • Contact: Elizabeth W Twamley, PhD; Phone Number: 858-642-3848; Email: Elizabeth.Twamley@va.gov
      • Contact: Michelle P Seewald, MA; Phone Number: (858) 255-4368; Email: Michelle.Seewald@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PACT; Personalized Augmented Cognitive Training (PACT)	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.
ACTIVE_COMPARATOR: ETAU; Enhanced Treatment As Usual (ETAU)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Neurobehavioral Symptom Inventory (NSI)	Measure of post concussive symptoms	6, 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Veterans Medical Research Foundation
• Collaborators: United States Naval Medical Center, San Diego
• Investigators: Principal Investigator: Elizabeth W Twamley, PhD, Veterans Medical Research Foundation; Principal Investigator: Mark L Ettenhofer, PhD, Veterans Medical Research Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ANTICIPATED): September 29, 2022
• Study Completion (ANTICIPATED): September 29, 2022

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (ACTUAL): September 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: cognitive rehabilitation; traumatic brain injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: W81XWH1910656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No