Trial Outcomes & Findings for Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI (NCT NCT01921179)

NCT ID: NCT01921179

Last Updated: 2020-02-17

Results Overview

Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching. (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

baseline, 5 weeks

Results posted on

2020-02-17

Participant Flow

Out of 76 enrolled participants: 12 were excluded after in person screening for not meeting inclusion criteria CAPS diagnosis of PTSD (n=11), or substance abuse (n=1); 8 participants left study after consent for scheduling, medical/family issues; and 10 left study during baseline assessment (were not randomized) 46 participants were randomized

Participant milestones

Participant milestones
Measure	GOALS (Goal-Oriented Attentional Regulation) Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.	EDU (Brain Health Education) Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
5 Week Randomized GOALS vs EDU Training STARTED	24	22
5 Week Randomized GOALS vs EDU Training COMPLETED	21	19
5 Week Randomized GOALS vs EDU Training NOT COMPLETED	3	3
Long Term Follow-up After GOALS Training STARTED	34	0
Long Term Follow-up After GOALS Training COMPLETED	32	0
Long Term Follow-up After GOALS Training NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	GOALS (Goal-Oriented Attentional Regulation) Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.	EDU (Brain Health Education) Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
5 Week Randomized GOALS vs EDU Training Withdrawal by Subject	3	3
Long Term Follow-up After GOALS Training Lost to Follow-up	2	0

Baseline Characteristics

Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GOALS (Goal-Oriented Attentional Regulation) n=21 Participants Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to GOALS intervention, did no receive EDU training after completion of GOALS.	EDU (Brain Health Education) n=19 Participants Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training , 3 hours of individual training ,and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects who completed EDU training during the randomized phase, completed additional 5 weeks of GOALS training.	Total n=40 Participants Total of all reporting groups
Age, Continuous	42.1 years STANDARD_DEVIATION 13.95 • n=5 Participants	47.53 years STANDARD_DEVIATION 14.86 • n=7 Participants	45.08 years STANDARD_DEVIATION 14.74 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Attention/Executive Function Overall Z Score	-0.39 z score STANDARD_DEVIATION 0.72 • n=5 Participants	-0.38 z score STANDARD_DEVIATION 0.77 • n=7 Participants	-0.39 z score STANDARD_DEVIATION 0.72 • n=5 Participants
Goal Processing Scale (GPS) Overall Performance Score	7.17 score on a scale STANDARD_DEVIATION 1.48 • n=5 Participants	7.31 score on a scale STANDARD_DEVIATION 1.44 • n=7 Participants	7.27 score on a scale STANDARD_DEVIATION 1.39 • n=5 Participants
Profile of Mood States (POMS)-Total Mood Disturbance Score	-1.69 z score STANDARD_DEVIATION 1.57 • n=5 Participants	-1.94 z score STANDARD_DEVIATION 1.06 • n=7 Participants	-1.81 z score STANDARD_DEVIATION 1.34 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, 5 weeks

Population: Out of 21 participants who completed GOALS, 3 participants did not complete one or more neuropsychological tests

Outcome measures

Outcome measures
Measure	GOALS (Goal-Oriented Attentional Regulation) n=18 Participants Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals. Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.	EDU (Brain Health Education) n=19 Participants Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework. Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training	-0.03 z score Standard Deviation 0.68	-0.39 z score Standard Deviation 0.72

PRIMARY outcome

Timeframe: baseline, 6+ months after GOALS training

Outcome measures

Outcome measures
Measure	GOALS (Goal-Oriented Attentional Regulation) n=27 Participants Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals. Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.	EDU (Brain Health Education) Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework. Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline	-0.2 z score Standard Deviation 0.78	—

SECONDARY outcome

Timeframe: baseline; 5 weeks

Population: Out of 21 participants who completed GOALS training 3 participants did not complete one or more sub-tests of GPS. Out of 19 participants who completed EDU training 2 participants did not complete one or more sub-tests of GPS

Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome.

Outcome measures

Outcome measures
Measure	GOALS (Goal-Oriented Attentional Regulation) n=18 Participants Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals. Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.	EDU (Brain Health Education) n=17 Participants Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework. Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training	8.10 score on a scale Standard Deviation 1.10	7.60 score on a scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: baseline, 6 months post GOALS training

Outcome measures

Outcome measures
Measure	GOALS (Goal-Oriented Attentional Regulation) n=24 Participants Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals. Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.	EDU (Brain Health Education) Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework. Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline	8.23 score on a scale Standard Deviation 1.20	—

SECONDARY outcome

Timeframe: baseline, 5 weeks

Population: Out of 21 participants who completed GOALS training 3 participants did not complete one or more questions on POMS Out of 19 participants who completed EDU training 2 participants did not complete one or more questions on POMS

Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure). (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)

Outcome measures

Outcome measures
Measure	GOALS (Goal-Oriented Attentional Regulation) n=18 Participants Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals. Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.	EDU (Brain Health Education) n=17 Participants Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework. Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training	-1.37 z score Standard Deviation 1.82	-2.09 z score Standard Deviation 0.94

SECONDARY outcome

Timeframe: baseline, 6 months

Overall psychological distress is assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure) (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)

Outcome measures

Outcome measures
Measure	GOALS (Goal-Oriented Attentional Regulation) n=25 Participants Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals. Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.	EDU (Brain Health Education) Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework. Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention	-1.01 z score Standard Deviation 1.40	—

Adverse Events

GOALS (Goal-Oriented Attentional Regulation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EDU (Brain Health Education)

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

Dr Tatjana Novakovic-Agopian

San Francisco VA HCS

Phone: 415-753-3888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place