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

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ClinicalTrials.gov Identifier: NCT04560946
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborator:
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Personalized Augmented Cognitive Training (PACT) Behavioral: Enhanced Treatment As Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two group randomized controlled trial.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors will be blind to treatment group assignment.
Primary Purpose: Treatment
Official Title: Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 29, 2022
Estimated Study Completion Date : September 29, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in the Neurobehavioral Symptom Inventory (NSI) [ Time Frame: 6, 12 weeks ]
    Measure of post concussive symptoms


Secondary Outcome Measures :
  1. Change in UCSD Performance-Based Skills Assessment-B (UPSA-B) [ Time Frame: 6, 12 weeks ]
    Measure of everyday communication and financial capacity

  2. Change in WMS-IV Digit Span [ Time Frame: 6, 12 weeks ]
    Measure of verbal working memory

  3. Change in California Verbal Learning Test-III (CVLT-III) [ Time Frame: 6, 12 weeks ]
    Measure of verbal and learning memory

  4. Change in D-KEFS Verbal Fluency [ Time Frame: 6, 12 weeks ]
    Measure of executive function

  5. Change in Oral Trails [ Time Frame: 6, 12 weeks ]
    Measure of visual psychomotor, and executive processes

  6. Change in Test My Brain Continuous Performance Test [ Time Frame: 6, 12 weeks ]
    Measure of sustained attention

  7. Change in Test My Brain Matrix Reasoning [ Time Frame: 6, 12 weeks ]
    Measure of visual reasoning

  8. Change in Test My Brain Digit Symbol Matching [ Time Frame: 6, 12 weeks ]
    Measure of visual scanning and information processing speed

  9. Change in Test My Brain Choice Reaction Time [ Time Frame: 6, 12 weeks ]
    Measure of reaction time

  10. Change in the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 6, 12 weeks ]
    Measure of sleep quality and disturbances over the past month

  11. Change in Cognitive Problems and Strategies Assessment [ Time Frame: 6, 12 weeks ]
    Measure of frequency of use of common strategies to enhance cognitive performance, as well as perceived cognitive problems

  12. Change in Patient Global Impression of Change (PGIC) [ Time Frame: 6, 12 weeks ]
    Measure of activity limitations, symptoms, and overall quality of life

  13. Change in Traumatic Brain Injury Quality of Life (TBI-QoL) [ Time Frame: 6, 12 weeks ]
    Measure of patient reported outcomes and NINDS CDEs for TBI

  14. Change in WHO Disability Assessment Schedule (WHODAS) 2.0 (plus supplementary questions for duty status, work/school) [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560946


Contacts
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Contact: Elizabeth W Twamley, PhD (858) 642-3848 Elizabeth.Twamley@va.gov
Contact: Mark L Ettenhofer, PhD (619) 532-6601 Mark.L.Ettenhofer.ctr@mail.mil

Locations
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United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Mark L Ettenhofer, PhD    619-532-6601    Mark.L.Ettenhofer.ctr@mail.mil   
Contact: Angelica D Aguirre, MPH, CCRC    619-532-6132    angelica.d.aguirre2.ctr@mail.mil   
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact: Elizabeth W Twamley, PhD    858-642-3848    Elizabeth.Twamley@va.gov   
Contact: Michelle P Seewald, MA    (858) 255-4368    Michelle.Seewald@va.gov   
Sponsors and Collaborators
Veterans Medical Research Foundation
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Elizabeth W Twamley, PhD Veterans Medical Research Foundation
Principal Investigator: Mark L Ettenhofer, PhD Veterans Medical Research Foundation
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Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT04560946    
Other Study ID Numbers: W81XWH1910656
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Veterans Medical Research Foundation:
traumatic brain injury
cognitive rehabilitation
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries