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

NCT04560946 | Completed

• 1 other identifier: W81XWH1910656
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; cognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in the Neurobehavioral Symptom Inventory (NSI)

  Measure of post concussive symptoms

  6, 12 weeks

Secondary Outcomes (14)

• Change in UCSD Performance-Based Skills Assessment-B (UPSA-B)

  6, 12 weeks

• Change in WMS-IV Digit Span

  6, 12 weeks

• Change in California Verbal Learning Test-III (CVLT-III)

  6, 12 weeks

• Change in D-KEFS Verbal Fluency

  6, 12 weeks

• Change in Oral Trails

  6, 12 weeks

Study Arms (2)

PACT

EXPERIMENTAL

Personalized Augmented Cognitive Training (PACT)

Behavioral: Personalized Augmented Cognitive Training (PACT)

ETAU

ACTIVE COMPARATOR

Enhanced Treatment As Usual (ETAU)

Behavioral: Enhanced Treatment As Usual

Interventions

Personalized Augmented Cognitive Training (PACT) BEHAVIORAL

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.

PACT

Enhanced Treatment As Usual BEHAVIORAL

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.

ETAU

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• United States Naval Medical Center, San Diego: collaborator

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Elizabeth W Twamley, PhD

  Veterans Medical Research Foundation

  PRINCIPAL INVESTIGATOR

• Mark L Ettenhofer, PhD

  Veterans Medical Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blind to treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two group randomized controlled trial.

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 23, 2020
• Study Start: September 30, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 21, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)