Trial Outcomes & Findings for Metacognitive Training to Enhance Strategy Use in Blast-Related TBI (NCT NCT00857207)

Last Updated: 2021-03-30

Results Overview

a computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards within 60 seconds. Each baseline and 10 week set of 30 problems consists of the same number of 4, 5, 6 or 7 move problems and has the same average difficulty level. The dependent variables are the total time spent solving the problem (0-60 seconds for each problem; less time is better) and the proportion of optimal moves (toward the goal 0-1 with 1 being the best outcome) and time to first move (0-60 seconds with more planning time indicating better outcome).

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

Baseline, 10 weeks

Results posted on

2021-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Treatment Goal Management Training Treatment Goal Management Training Goal Management Training: Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.	Arm 2: Control-Brain Health Workshop Control-Brain Health Workshop Brain Health Workshop is a 10-week therapy that teaches information about how the brain works with equal contact to the therapist as Goal Management Training
Overall Study STARTED	48	3
Overall Study COMPLETED	14	3
Overall Study NOT COMPLETED	34	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Treatment Goal Management Training Treatment Goal Management Training Goal Management Training: Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.	Arm 2: Control-Brain Health Workshop Control-Brain Health Workshop Brain Health Workshop is a 10-week therapy that teaches information about how the brain works with equal contact to the therapist as Goal Management Training
Overall Study Withdrawal by Subject	13	0
Overall Study did not meet inclusion criteria for deficit in inhibition or failed the TOMM	18	0
Overall Study Subject chose not to participate after signing consent	3	0

Baseline Characteristics

Metacognitive Training to Enhance Strategy Use in Blast-Related TBI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Treatment Goal Management Training n=14 Participants Treatment Goal Management Training Goal Management Training: Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.	Arm 2: Control-Brain Health Workshop n=3 Participants Control-Brain Health Workshop Brain Health Workshop is a 10-week therapy that teaches information about how the brain works with equal contact to the therapist as Goal Management Training	Total n=17 Participants Total of all reporting groups
Age, Continuous	38.4 years STANDARD_DEVIATION 7.2 • n=5 Participants	41.7 years STANDARD_DEVIATION 4.2 • n=7 Participants	38.98 years STANDARD_DEVIATION 6.59 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	3 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants	3 Participants n=7 Participants	17 Participants n=5 Participants
Post-traumatic stress disorder checklist-military version	60.9 units on a scale STANDARD_DEVIATION 16.4 • n=5 Participants	64.3 units on a scale STANDARD_DEVIATION 4.7 • n=7 Participants	62.6 units on a scale STANDARD_DEVIATION 14.86 • n=5 Participants
Beck's Depression Inventory-II	31 units on a scale STANDARD_DEVIATION 12.2 • n=5 Participants	25.7 units on a scale STANDARD_DEVIATION 12.0 • n=7 Participants	30.06 units on a scale STANDARD_DEVIATION 11.97 • n=5 Participants
North American Reading Test Estimated Intelligence Quotion	111.1 units on a scale STANDARD_DEVIATION 7.02 • n=5 Participants	104.4 units on a scale STANDARD_DEVIATION 8.1 • n=7 Participants	109.95 units on a scale STANDARD_DEVIATION 7.22 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 10 weeks

Population: t-test

Outcome measures

Outcome measures
Measure	Arm 1: Treatment Goal Management Training n=14 Participants Treatment Goal Management Training Goal Management Training: Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.	Arm 2: Control-Brain Health Workshop n=3 Participants Control-Brain Health Workshop Brain Health Workshop is a 10-week therapy that teaches information about how the brain works with equal contact to the therapist as Goal Management Training
Computerized Tower Of London (cTOL) cTOL Total time baseline	24.6 Seconds Standard Deviation 5.37	25.1 Seconds Standard Deviation 4.43
Computerized Tower Of London (cTOL) cTOL Total time post treatment	21.7 Seconds Standard Deviation 4.3	24.7 Seconds Standard Deviation 1.68
Computerized Tower Of London (cTOL) cTOL Time to first move baseline	7.98 Seconds Standard Deviation 2.44	9.11 Seconds Standard Deviation 0.79
Computerized Tower Of London (cTOL) cTOL Time to first move Post	8.21 Seconds Standard Deviation 2.01	12.6 Seconds Standard Deviation 2.41

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: T-test

Behavior Rating Inventory of Executive Functions-Adult (BRIEF-A) is a self and informant report questionnaire consisting of 75 statements about executive behaviors. There are three possible responses to items: often, sometimes, never. Two subscale scores behavioral regulation index and metacognitive index are reported as T-scores adjusted for age with a possible score of 0-100. Lower scores are better indicating less trouble with executive function.

Outcome measures

Outcome measures
Measure	Arm 1: Treatment Goal Management Training n=14 Participants Treatment Goal Management Training Goal Management Training: Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.	Arm 2: Control-Brain Health Workshop n=3 Participants Control-Brain Health Workshop Brain Health Workshop is a 10-week therapy that teaches information about how the brain works with equal contact to the therapist as Goal Management Training
BRIEF-A BRIEF Metacognitive Index Baseline	78.6 score on a scale Standard Deviation 11.1	70.3 score on a scale Standard Deviation 9.29
BRIEF-A BRIEF-A Metacognitive Index Post	75.9 score on a scale Standard Deviation 11.0	68.7 score on a scale Standard Deviation 20.5
BRIEF-A BRIEF-A Behavioral Regulation Index Baseline BRIEF-A Behavioral Regulation Index Baseline	72.1 score on a scale Standard Deviation 13.1	66.3 score on a scale Standard Deviation 3.79
BRIEF-A BRIEF-A Behavioral Regulation Index Post	69.5 score on a scale Standard Deviation 12.8	60.0 score on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: baseline, 10 weeks

Population: Veterans with mTBI

computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards within 60 seconds. Each baseline and 10 week set of 30 problems consists of the same number of 4, 5, 6 or 7 move problems and has the same average difficulty level. Optimal moves are a proportion of optimal moves (toward the goal 0-1 with 1 being the best outcome).

Outcome measures

Outcome measures
Measure	Arm 1: Treatment Goal Management Training n=14 Participants Treatment Goal Management Training Goal Management Training: Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.	Arm 2: Control-Brain Health Workshop n=3 Participants Control-Brain Health Workshop Brain Health Workshop is a 10-week therapy that teaches information about how the brain works with equal contact to the therapist as Goal Management Training
cTOL Optimal Moves Baseline Optimal Moves	0.67 proportion of optimal moves Standard Deviation 0.13	0.71 proportion of optimal moves Standard Deviation 0.03
cTOL Optimal Moves 10 week Optimal moves	0.71 proportion of optimal moves Standard Deviation 0.12	0.80 proportion of optimal moves Standard Deviation 0.07

Adverse Events

Arm 1: Treatment Goal Management Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Control-Brain Health Workshop

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

Julia Kay Waid-Ebbs, Health Science Specialist

Malcom Randall VAMC

Phone: 352-871-0282

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place