Combining Attention and Metacognitive Training to Improve Goal Directed Behavior in Veterans With TBI

NCT04044456 | Completed Results

• 1 other identifier: N3189-P
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Veterans with mild traumatic brain injury continue to deal with symptoms that interfere with their ability to engage in productive activities. In combination with other psychosocial difficulties, impairments are found in cognition, such as attention and executive function. Few interventions are available to treat attention in Veterans with mTBI. Of the interventions available, none rigorously train attention combined with strategy training. This project will innovatively combine a strategy training called Goal Management Training with computerized attention training to improve tests of problem solving, attention and functional tasks compared to a control group.

Conditions

Mild Traumatic Brain Injury

Keywords

Brain Injury; Cognition; Veteran; Attention; Metacognition

Outcome Measures

Primary Outcomes (2)

• Computerized Tower of London Average Time to Complete Problems/Total Time

  Computerized Tower of London (cTOL) total time, week 1, week 11 and week 36. Complete game board of three colored balls to match goal board in the least amount of moves and as quickly as possible. range of total time is 0-59 seconds with lower time=better performance.

  week 1, 11, 36

• Test of Grocery Shopping Skills

  Total time, week 1 and week 11 on a task of shopping in a local grocery store for 10 items as efficiently as possible, while selecting the correct size and cheapest unit cost. Total time with lower times=better performance.

  week 1, 11

Secondary Outcomes (2)

• Attention Network Task

  week 1, 11, 36

• Community Reintegration of Service Members

  week 1, 11, 36

Study Arms (2)

GMT plus attention

EXPERIMENTAL

GMT consists of 2-hour, 10 weekly sessions using an interactive Power Point presentations. Attention training consists of 2-hour computerized attention training using Attention Process Training III and Brain HQ.

Behavioral: Goal Management Training; Behavioral: Attention Training

BHW plus movies

PLACEBO COMPARATOR

Brain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions).

Behavioral: Brain Health Workshop; Behavioral: National geographic movies

Interventions

Goal Management Training BEHAVIORAL

GMT: is a 10-session intervention to improve planning and problem solving. Interactive Power Point modules are administered by a cognitive therapist. Each session builds on the steps of a five-stage planning and problem-solving strategy. Veterans will be taught to generate and verbalize the following five-steps: "stop-what am I doing?", "define the goal", "list the steps", "learn the steps"; then, "check-am I doing what I planned?" The five-stage strategy is then incorporated into a variety of activities in the laboratory and in-home assignments.

Also known as: GMT

GMT plus attention

Attention Training BEHAVIORAL

Attention Process Training (APT-III) will be administered for a second weekly session in addition to the GMT session. Each session will be 2 hours/ week for 10 weeks. Veterans will also engage in BrainHQTM attention training at home for one-hour, five days/ week comprised of selected components of BrainHQ from Posit Science Corporation. This web-based computerized CRT modality of cognitive training is a restorative or "bottom-up" approach that targets basic cognitive skills such as arousal and vigilance processes, attention and information processing, and directly engages fundamental attention-control skills through repetitive graded exercises.

Also known as: APT III, Brain HQ

GMT plus attention

Brain Health Workshop BEHAVIORAL

. BHW was developed specifically for consistency with GMT session length and contact with the facilitator49. BHW is an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered. To match time and contact of attention training, control participants will meet with the therapist for a separate two-hour session from BHW

Also known as: BHW

BHW plus movies

National geographic movies BEHAVIORAL

participants will select movies to watch and answer a few questions about to equate the time and therapist interaction to attention training in arm 1.

Also known as: movies

BHW plus movies

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Veterans with a diagnosis mTBI between the ages of 18 to 55, that demonstrate a deficit in attention, pass effort testing and have not changed psychotropic medication within the past two weeks.
• all Veterans who have served in OIF-OEF-OND with single- (at least brief loss of conscious) or multiple (with at least alteration of consciousness) mild traumatic brain injury (mTBI) during deployment, who seek services at North Florida/South Georgia Veterans Health System (NF-VHS).
• TBI must have suffered their injury at least 6 months prior to study enrollment and currently be in stable neurological condition.
• age range 19-55 years to reduce the impact of aging on treatment improvement.
• Attention deficit of 1.5 SD below the mean of the RBANS attention index. This will ensure that participants have an objective deficit attention.
• Family member or friend that is willing to complete the BRIEF-A (BRIEF-A guidelines of face to face interaction with the participant at least twice a week) at all measurement time points.
• Access to a home computer, or smartphone with internet access.

You may not qualify if:

• History of pre-morbid learning disability
• History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
• Neurological disease unrelated to TBI (seizure disorder, stroke)
• Score \< 90 on National Adult Reading Test (NART)
• Failure of validity testing on either the Test of Memory Malingering (TOMM),). Score of 45 or less on TOMM Trial 2 or retention trial.
• Reported alcohol or substance abuse within the past year
• Reported involvement in current litigation
• Recent change of medications for seizures, depression or memory.
• Currently enrolled in other cognitive therapy that cannot be discontinued
• Does not speak English fluently
• Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).
• Uncontrolled, acute medical or psychiatric condition as indicated by the participant or observed by the research team member that would make it unsafe to participate in the research activities, i.e. precautions for active homicidal/suicidal intent, active psychosis, or acute symptoms requiring immediate medical attention.
• Psychotropic drugs that have changed within the past two-weeks that would impact performance during assessment.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries

Interventions

Motion Pictures

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Health Science Specialist
• Organization: Malcom Randall VAMC

julia.waid-ebbs@va.gov

352-376-1611

Study Officials

• Julia K. Waid-Ebbs, PhD

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: participants meeting inclusion criteria will be randomized to either treatment (Goal management training and attention training) or control (Brain Health Workshop and national geographic movies).

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 30, 2024
• Results First Posted: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)