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

Primary Purpose

Traumatic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Augmented Cognitive Training (PACT)
Enhanced Treatment As Usual
Sponsored by
Veterans Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, cognitive rehabilitation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Naval Medical Center San DiegoRecruiting
  • VA San Diego Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PACT

ETAU

Arm Description

Personalized Augmented Cognitive Training (PACT)

Enhanced Treatment As Usual (ETAU)

Outcomes

Primary Outcome Measures

Change in the Neurobehavioral Symptom Inventory (NSI)
Measure of post concussive symptoms

Secondary Outcome Measures

Change in UCSD Performance-Based Skills Assessment-B (UPSA-B)
Measure of everyday communication and financial capacity
Change in WMS-IV Digit Span
Measure of verbal working memory
Change in California Verbal Learning Test-III (CVLT-III)
Measure of verbal and learning memory
Change in D-KEFS Verbal Fluency
Measure of executive function
Change in Oral Trails
Measure of visual psychomotor, and executive processes
Change in Test My Brain Continuous Performance Test
Measure of sustained attention
Change in Test My Brain Matrix Reasoning
Measure of visual reasoning
Change in Test My Brain Digit Symbol Matching
Measure of visual scanning and information processing speed
Change in Test My Brain Choice Reaction Time
Measure of reaction time
Change in the Pittsburgh Sleep Quality Index (PSQI)
Measure of sleep quality and disturbances over the past month
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
Change in Patient Global Impression of Change (PGIC)
Measure of activity limitations, symptoms, and overall quality of life
Change in Traumatic Brain Injury Quality of Life (TBI-QoL)
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)
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

Full Information

First Posted
September 16, 2020
Last Updated
September 28, 2020
Sponsor
Veterans Medical Research Foundation
Collaborators
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04560946
Brief Title
Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI
Acronym
PACT
Official Title
Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 29, 2022 (Anticipated)
Study Completion Date
September 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
United States Naval Medical Center, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, cognitive rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group randomized controlled trial.
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will be blind to treatment group assignment.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth W Twamley, PhD
Phone
(858) 642-3848
Email
Elizabeth.Twamley@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Mark L Ettenhofer, PhD
Phone
(619) 532-6601
Email
Mark.L.Ettenhofer.ctr@mail.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth W Twamley, PhD
Organizational Affiliation
Veterans Medical Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark L Ettenhofer, PhD
Organizational Affiliation
Veterans Medical Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark L Ettenhofer, PhD
Phone
619-532-6601
Email
Mark.L.Ettenhofer.ctr@mail.mil
First Name & Middle Initial & Last Name & Degree
Angelica D Aguirre, MPH, CCRC
Phone
619-532-6132
Email
angelica.d.aguirre2.ctr@mail.mil
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth W Twamley, PhD
Phone
858-642-3848
Email
Elizabeth.Twamley@va.gov
First Name & Middle Initial & Last Name & Degree
Michelle P Seewald, MA
Phone
(858) 255-4368
Email
Michelle.Seewald@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared with other researchers.

Learn more about this trial

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

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