Trial Outcomes & Findings for Enhancement of PTSD Treatment With Computerized Executive Function Training (NCT NCT03260127)

Results Overview

Wisconsin Card Sorting Test (WCST) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -22 to 15, higher scores mean a worse outcome

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

change from baseline to completion of computerized cognitive training (6 weeks)

Results posted on

2024-04-01

Participant Flow

All participants who were were enrolled were randomly assigned to groups.

Participant milestones

Participant milestones
Measure	CEFT-CPT Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
Overall Study STARTED	42	40
Overall Study Post-training Assessment	31	32
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	20	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancement of PTSD Treatment With Computerized Executive Function Training

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CEFT-CPT n=42 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=40 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	Total n=82 Participants Total of all reporting groups
Age, Continuous	37.07 Years STANDARD_DEVIATION 8.14 • n=5 Participants	38.40 Years STANDARD_DEVIATION 8.31 • n=7 Participants	37.72 Years STANDARD_DEVIATION 8.20 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	24 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Education in years	14.93 years STANDARD_DEVIATION 1.83 • n=5 Participants	15.25 years STANDARD_DEVIATION 2.10 • n=7 Participants	15.09 years STANDARD_DEVIATION 1.96 • n=5 Participants

PRIMARY outcome

Timeframe: change from baseline to completion of computerized cognitive training (6 weeks)

Population: Two participants did not complete this measure prior to being lost to follow-up

Wisconsin Card Sorting Test (WCST) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -22 to 15, higher scores mean a worse outcome

Outcome measures

Outcome measures
Measure	CEFT-CPT n=29 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=32 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
Wisconsin Card Sorting Test (WCST)	-2.69 score on a scale Standard Deviation 4.24	-1.47 score on a scale Standard Deviation 6.41

PRIMARY outcome

Timeframe: change from baseline to completion of computerized cognitive training (6 weeks)

Paced Auditory Serial Addition Test (PASAT) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -22 to 47, higher scores mean a better outcome

Outcome measures

Outcome measures
Measure	CEFT-CPT n=31 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=32 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
Paced Auditory Serial Addition Test (PASAT)	14.32 score on a scale Standard Deviation 13.03	10.88 score on a scale Standard Deviation 14.61

PRIMARY outcome

Timeframe: change from baseline to completion of computerized cognitive training (6 weeks)

Population: A participant was not able to complete this measure due to color blindness

Delis Kaplan Executive Function System (D-KEFS) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -39 to 27, higher scores mean a worse outcome

Outcome measures

Outcome measures
Measure	CEFT-CPT n=31 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=31 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
Delis Kaplan Executive Function System (D-KEFS)	-4.90 score on a scale Standard Deviation 8.83	-3.81 score on a scale Standard Deviation 10.05

PRIMARY outcome

Timeframe: change in subjective executive functioning from baseline to completion of computerized cognitive training (6 weeks)

Population: Two participants did not complete this measure prior to being lost to follow-up

Behavior Rating Inventory of Executive Function (BRIEF) is a self-report measure of executive functioning, items are summed to create a total score, range: -32 to 30, higher scores mean a worse outcome

Outcome measures

Outcome measures
Measure	CEFT-CPT n=29 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=32 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
Behavior Rating Inventory of Executive Function (BRIEF)	-6.52 score on a scale Standard Deviation 12.39	-3.50 score on a scale Standard Deviation 16.29

PRIMARY outcome

Timeframe: change from baseline to completion of computerized cognitive training (6 weeks)

Population: One participant did not complete this measure prior to being lost to follow-up

Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span Sequencing subtest is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -3 to 3, higher scores mean a better outcome

Outcome measures

Outcome measures
Measure	CEFT-CPT n=30 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=32 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
WAIS-IV Digit Span Sequencing Subtest	1.03 score on a scale Standard Deviation 1.63	.31 score on a scale Standard Deviation 1.57

PRIMARY outcome

Timeframe: change from baseline to completion of computerized cognitive training (6 weeks)

Population: Some participants were unable to complete this measure due to COVID restrictions related to in-person study visits

N-Back is a task that tests executive functioning, range: -.25 to .28, higher scores means a better outcome

Outcome measures

Outcome measures
Measure	CEFT-CPT n=27 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=32 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
N-Back Task Performance	.04 score on a scale Standard Deviation .12	-.01 score on a scale Standard Deviation .11

PRIMARY outcome

Timeframe: change from baseline to completion of computerized cognitive training (6 weeks)

Population: Some participants were unable to complete this measure due to COVID restrictions related to in-person study visits

Go/No-Go is a task that tests executive functioning, range: -.04 to .02, higher scores mean a worse outcome

Outcome measures

Outcome measures
Measure	CEFT-CPT n=27 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=32 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
Go/No-Go Task Performance	-.01 score on a scale Standard Deviation .01	-.001 score on a scale Standard Deviation .02

SECONDARY outcome

Timeframe: change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment

Clinician-Administered PTSD Scale for DSM 5 (CAPS-5) is a clinical interview assessing PTSD symptoms that will be administered at 3 time points: baseline, after completion of cognitive training, and after completion of Cognitive Processing Therapy, range: -38 to 18, higher scores mean a worse outcome

Outcome measures

Outcome measures
Measure	CEFT-CPT n=22 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=23 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
Clinician-Administered PTSD Scale for DSM 5 (CAPS-5)	-8.18 score on a scale Standard Deviation 13.20	-4.96 score on a scale Standard Deviation 11.67

SECONDARY outcome

Timeframe: change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment

PTSD Checklist for DSM-5 (PCL-5) is a self-report questionnaire that will be administered at 15 time points: at baseline, after completion of cognitive training, at each of the 12 therapy sessions, and after completion of Cognitive Processing Therapy, range: -49 to 28, higher scores mean a worse outcome

Outcome measures

Outcome measures
Measure	CEFT-CPT n=22 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=23 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
PTSD Checklist for DSM-5 (PCL-5)	-12.64 score on a scale Standard Deviation 17.85	-11.70 score on a scale Standard Deviation 12.32

SECONDARY outcome

Timeframe: change in quality of life from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment

World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self-report questionnaire assessing quality of life that will be administered at 3 time points: baseline, after completion of cognitive training, and after completion of Cognitive Processing Therapy. Four subscales are computed (range 4-20): physical health, psychological, social relationships, and environment, range: -2.7 to 6.7, higher scores mean a better outcome

Outcome measures

Outcome measures
Measure	CEFT-CPT n=22 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=23 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
World Health Organization Quality of Life - BREF	1.61 score on a scale Standard Deviation 2.52	1.39 score on a scale Standard Deviation 2.10

SECONDARY outcome

Timeframe: time (in minutes) spent completing homework from CPT session 1 to CPT session 12 (across approximately 6 weeks, weeks 7-12 after baseline)

Population: Number of participants reflect only those participants who completed at least 2 sessions of CPT (i.e., enough sessions to complete at least one homework assignment)

At each of the CPT sessions, participants will report how much time they spent completing homework since the previous session

Outcome measures

Outcome measures
Measure	CEFT-CPT n=28 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=29 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
Time (in Minutes) Spent Completing Cognitive Processing Therapy Homework	426.68 minutes Standard Deviation 356.59	448.28 minutes Standard Deviation 610.06

SECONDARY outcome

Timeframe: CPT sessions completed (out of a possible 12) after completing the cognitive training (across approximately 6 weeks, weeks 7-12 after baseline)

Number of CPT sessions completed out of a possible total of 12 sessions

Outcome measures

Outcome measures
Measure	CEFT-CPT n=42 Participants Computerized executive function training plus Cognitive Processing Therapy for PTSD Computerized executive function training plus CPT (CEFT-CPT): Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)	WT-CPT n=40 Participants Word game training plus Cognitive Processing Therapy for PTSD Word game training plus CPT (WT-CPT): Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
Number of CPT Sessions Completed	6.76 number of CPT sessions completed Standard Deviation 5.56	7.78 number of CPT sessions completed Standard Deviation 5.31

Adverse Events

CEFT-CPT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

WT-CPT

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

Laura Crocker

VA San Diego Healthcare System

Phone: 8586426484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place