Trial Outcomes & Findings for Combining Attention and Metacognitive Training to Improve Goal Directed Behavior in Veterans With TBI (NCT NCT04044456)
NCT ID: NCT04044456
Last Updated: 2024-08-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
week 1, 11, 36
Results posted on
2024-08-30
Participant Flow
Participant milestones
| Measure |
GMT Plus Attention
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.
Goal Management Training: 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.
Attention Training: 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.
|
BHW Plus Movies
Brain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions).
Brain Health Workshop: . 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
National geographic movies: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
2
|
|
Overall Study
COMPLETED
|
13
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
GMT Plus Attention
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.
Goal Management Training: 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.
Attention Training: 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.
|
BHW Plus Movies
Brain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions).
Brain Health Workshop: . 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
National geographic movies: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
number analyzed were participants that completed treatment
Baseline characteristics by cohort
| Measure |
GMT Plus Attention
n=18 Participants
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.
Goal Management Training: 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.
Attention Training: 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.
|
BHW Plus Movies
n=2 Participants
Brain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions).
Brain Health Workshop: . 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
National geographic movies: 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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 6.54 • n=13 Participants • number analyzed were participants that completed treatment
|
38 years
STANDARD_DEVIATION 0 • n=1 Participants • number analyzed were participants that completed treatment
|
42 years
STANDARD_DEVIATION 6.52 • n=14 Participants • number analyzed were participants that completed treatment
|
|
Sex: Female, Male
Female
|
3 Participants
n=18 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=18 Participants
|
2 Participants
n=2 Participants
|
17 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=18 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=18 Participants
|
1 Participants
n=2 Participants
|
18 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=18 Participants
|
1 Participants
n=2 Participants
|
11 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=18 Participants
|
1 Participants
n=2 Participants
|
9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=18 Participants
|
2 Participants
n=2 Participants
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: week 1, 11, 36Population: Veterans with mild TBI that completed GMT training and 1 Veteran with mild TBI that completed the control sessions.
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.
Outcome measures
| Measure |
GMT Plus Attention
n=13 Participants
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.
Goal Management Training: 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.
Attention Training: 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.
|
BHW Plus Movies
n=1 Participants
Brain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions).
Brain Health Workshop: . 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
National geographic movies: 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.
|
|---|---|---|
|
Computerized Tower of London Average Time to Complete Problems/Total Time
Computerized Tower of London (cTOL) total time week 1
|
27.79 seconds
Standard Deviation 5.79
|
26.78 seconds
Standard Deviation 0
|
|
Computerized Tower of London Average Time to Complete Problems/Total Time
Computerized Tower of London (cTOL) total time week 11
|
25.21 seconds
Standard Deviation 5.07
|
22.44 seconds
Standard Deviation 0
|
|
Computerized Tower of London Average Time to Complete Problems/Total Time
Computerized Tower of London (cTOL) total time week 36
|
21.73 seconds
Standard Deviation 3.08
|
26.78 seconds
Standard Deviation 0
|
PRIMARY outcome
Timeframe: week 1, 11Total 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.
Outcome measures
| Measure |
GMT Plus Attention
n=13 Participants
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.
Goal Management Training: 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.
Attention Training: 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.
|
BHW Plus Movies
n=1 Participants
Brain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions).
Brain Health Workshop: . 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
National geographic movies: 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.
|
|---|---|---|
|
Test of Grocery Shopping Skills
Test of grocery shopping skills week 11
|
22.356 minutes
Standard Deviation 9.07
|
13.12 minutes
Standard Deviation 0
|
|
Test of Grocery Shopping Skills
Test of grocery shopping skills week 1
|
24.34 minutes
Standard Deviation 9.16
|
14.05 minutes
Standard Deviation 0
|
SECONDARY outcome
Timeframe: week 1, 11, 36Population: BHW participant 36 week Attention Network Task was not assessed.
Flanker task that dissociates attention into three components: alerting, orienting and executive control. Attention network effects were calculated using the following mean response time (RT) subtractions: alerting effect = no-cue RT minus center cue RT; orienting effect = invalid spatial cue RT minus valid spatial cue RT; executive control (conflict) effect = incongruent RT minus congruent RT. Mean response time for week 1, week 11 and week 36 on each component., lower=better performance.
Outcome measures
| Measure |
GMT Plus Attention
n=14 Participants
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.
Goal Management Training: 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.
Attention Training: 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.
|
BHW Plus Movies
n=1 Participants
Brain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions).
Brain Health Workshop: . 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
National geographic movies: 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.
|
|---|---|---|
|
Attention Network Task
Attention Network Task Alerting, week 1
|
9.79 milliseconds
Standard Deviation 30.04
|
38 milliseconds
Standard Deviation 0
|
|
Attention Network Task
Attention Network Task Alerting week 11
|
39.39 milliseconds
Standard Deviation 22.50
|
22 milliseconds
Standard Deviation 0
|
|
Attention Network Task
Attention Network Task Alerting week 36
|
31.54 milliseconds
Standard Deviation 15.88
|
—
|
|
Attention Network Task
Attention Network Task Orienting week 1
|
57.61 milliseconds
Standard Deviation 31.65
|
21 milliseconds
Standard Deviation 0
|
|
Attention Network Task
Attention Network Task Orienting week 11
|
51.21 milliseconds
Standard Deviation 31.65
|
15 milliseconds
Standard Deviation 0
|
|
Attention Network Task
Attention Network Task Orienting week 36
|
46.21 milliseconds
Standard Deviation 30.50
|
—
|
|
Attention Network Task
Attention Network Task EC week 1
|
130.96 milliseconds
Standard Deviation 64.88
|
145.5 milliseconds
Standard Deviation 0
|
|
Attention Network Task
Attention Network Task EC week 11
|
80.68 milliseconds
Standard Deviation 56.48
|
127 milliseconds
Standard Deviation 0
|
|
Attention Network Task
Attention Network Task EC week 36
|
83.29 milliseconds
Standard Deviation 29.22
|
—
|
SECONDARY outcome
Timeframe: week 1, 11, 36Population: week 36 was not assessed for the BHW participant
week 1, 11 and to week 36. The scale for each of the 46 items ranged from 1=extremely unsatisfied to 5=extremely satisfied. The total score is the mean of the responses of 46 items X 10. The range is 10 to 50 with higher numbers indicating better satisfaction with participation in the community.
Outcome measures
| Measure |
GMT Plus Attention
n=13 Participants
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.
Goal Management Training: 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.
Attention Training: 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.
|
BHW Plus Movies
n=1 Participants
Brain Health Workshop consists of 2-hour, 10 weekly sessions using Power Point presentations and national geographic movies (2-hour, 10 weekly sessions).
Brain Health Workshop: . 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
National geographic movies: 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.
|
|---|---|---|
|
Community Reintegration of Service Members
Community Reintegration of Service members Satisfaction week 1
|
23.23 score on a scale
Standard Deviation 7.11
|
28.8 score on a scale
Standard Deviation 0
|
|
Community Reintegration of Service Members
Community Reintegration of Service members Satisfaction week 11
|
27.97 score on a scale
Standard Deviation 7.02
|
29.29 score on a scale
Standard Deviation 0
|
|
Community Reintegration of Service Members
Community Reintegration of Service members Satisfaction week 36
|
27.59 score on a scale
Standard Deviation 9.62
|
—
|
Adverse Events
GMT Plus Attention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BHW Plus Movies
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place