NCT04044456

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

Completed NA Results posted Last updated 30 August 2024

What this trial tests

NA trial testing Goal Management Training in Mild Traumatic Brain Injury in 20 participants. Completed in 31 December 2022.

Timeline

1 January 2019

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	1 January 2019
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Goal Management Training
• Attention Training
• Brain Health Workshop
• National geographic movies

Conditions studied

• Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 19 to 55, any sex, with Mild Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Computerized Tower of London Average Time to Complete Problems/Total Time Primary · week 1, 11, 36

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.

Computerized Tower of London (cTOL) total time week 1

Group	Value	95% CI
GMT Plus Attention	27.79	± 5.79
BHW Plus Movies	26.78	± 0

Computerized Tower of London (cTOL) total time week 11

Group	Value	95% CI
GMT Plus Attention	25.21	± 5.07
BHW Plus Movies	22.44	± 0

Computerized Tower of London (cTOL) total time week 36

Group	Value	95% CI
GMT Plus Attention	21.73	± 3.08
BHW Plus Movies	26.78	± 0

Test of Grocery Shopping Skills Primary · week 1, 11

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.

Test of grocery shopping skills week 1

Group	Value	95% CI
GMT Plus Attention	24.34	± 9.16
BHW Plus Movies	14.05	± 0

Test of grocery shopping skills week 11

Group	Value	95% CI
GMT Plus Attention	22.356	± 9.07
BHW Plus Movies	13.12	± 0

Attention Network Task Secondary · week 1, 11, 36

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.

Attention Network Task Alerting, week 1

Group	Value	95% CI
GMT Plus Attention	9.79	± 30.04
BHW Plus Movies	38	± 0

Attention Network Task Alerting week 11

Group	Value	95% CI
GMT Plus Attention	39.39	± 22.50
BHW Plus Movies	22	± 0

Attention Network Task Alerting week 36

Group	Value	95% CI
GMT Plus Attention	31.54	± 15.88

Attention Network Task Orienting week 1

Group	Value	95% CI
GMT Plus Attention	57.61	± 31.65
BHW Plus Movies	21	± 0

Attention Network Task Orienting week 11

Group	Value	95% CI
GMT Plus Attention	51.21	± 31.65
BHW Plus Movies	15	± 0

Attention Network Task Orienting week 36

Group	Value	95% CI
GMT Plus Attention	46.21	± 30.50

Attention Network Task EC week 1

Group	Value	95% CI
GMT Plus Attention	130.96	± 64.88
BHW Plus Movies	145.5	± 0

Attention Network Task EC week 11

Group	Value	95% CI
GMT Plus Attention	80.68	± 56.48
BHW Plus Movies	127	± 0

Community Reintegration of Service Members Secondary · week 1, 11, 36

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.

Community Reintegration of Service members Satisfaction week 1

Group	Value	95% CI
GMT Plus Attention	23.23	± 7.11
BHW Plus Movies	28.8	± 0

Community Reintegration of Service members Satisfaction week 11

Group	Value	95% CI
GMT Plus Attention	27.97	± 7.02
BHW Plus Movies	29.29	± 0

Community Reintegration of Service members Satisfaction week 36

Group	Value	95% CI
GMT Plus Attention	27.59	± 9.62

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.